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Clinical Development / Phase IIb-IV

Compliance, Regulatory & Consulting

Core / Central Lab

Early Clinical / Phase I-IIa

Medical Writing & Language Translation

Packaging & Logistics

Patient / Investigator Recruitment

Post Marketing

Technology / Data / Analytics

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BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Basic Pharma

CLINICAL SUPPLIES MANAGEMENT HOLDINGS, INC.

Celerion

Chiltern International Ltd

ClinPlus

Covigilant LLC

Cryoport Systems Inc

DZS Clinical Services

ERT

Elligo Health Research

Evidera

Factory CRO

Greenleaf Health Inc

KAI Research

LabConnect

Legacy Pharmaceuticals Switzerland

Litera Microsystems

Lovelace Scientific Resources

MI Bioresearch

MPI Research Inc

Mapi Group

Merck Millipore

Navitas Inc

Nutrasource

OTTR Chronic Care Solutions

PAREXEL International Corporation

PHA Farmed d.o.o

Particle Sciences

Pharmaceutical Product Development, LLC

QUINTA-ANALYTICA s.r.o

Quorum Review, Inc.

Quotient Sciences

RegPak BioPharma

Reliance Clinical Testing Services, Inc

Spaulding Clinical, LLC

SubjectWell

Synexus Limited

TFS International AB

TransPerfect

Trial By Fire Solutions, LLC

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CANADA

CZECH REPUBLIC

NETHERLANDS

Netherlands

PORTUGAL

SLOVENIA

SWEDEN

SWITZERLAND

UNITED KINGDOM

UNITED STATES

Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

Phase I clinical trials, BE/BA study, general...

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Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

Virtual Booth Transforming Drug Development with Science & Innovation.

American DDF Summit

Phase 1 Clinical Pharmacology Study

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- Service Details

Quotient has the experience and expertise to deliver studies with the highest quality service and speed to clinical data. If you need a complete service including data management, data analysis, statistics and medical writing, Quotient is your answer.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

cGMP Global Storage & Distribution

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- Service Details

We offer a wide variety of solutions to accommodate your specific storage and distribution needs. For projects of any size and scope, CSM offers solutions through all stages of the supply chain as well as options to track and monitor your supplies in real-time.

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Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Storage Solutions

Premarket Preparation

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- Service Details

Greenleaf Health Inc. offers various services such as: Combination product designations; Requests for device classification (513(g)); Presubmission strategy; Identification of predicate devices; Determination of and compliance with performance data and labeling requirements; etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Medical Writing & Healthcare Communications

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- Service Details

Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully compliant with regulations, industry best practices, and your corporate guidance.

Global Regulatory Affairs Services

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- Service Details

PPD provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

ERT

  • FDA

ERT Imaging

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As the leading expert in holistic imaging for clinical trials and pre-market approval research, ERT Imaging helps you visualize and realize compliant, high-quality imaging results.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Radiolabeled ADME Studies

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- Service Details

In response to a growing interest in conducting human 14C-radiolabeled ADME studies earlier in drug development, Celerion has expanded its ADME suite in Lincoln, Nebraska.

Clinical Development Strategy

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DZS Clinical Services provides expert consultation and advice on the strategic direction of your clinical trial for your drug product or device across many therapeutic areas in the biopharmaceutical, medical device and government and nonprofit sectors.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

AxxiTRIALS

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AxxiTRIALS is a fully automated, unified eTMF and site investigator portal that allows regulatory document exchange between clinical trial sites and sponsors.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Subcutaneous Models

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- Service Details

At MI Bioresearch, we offer more than 450 syngeneic and human tumor xenograft models, including drug-resistant and specialty models, and we are continually validating new models.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Regulatory Outsourcing Services

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- Service Details

Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Best in Class Patient Retention

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We develop study-specific retention plans when needed but our main retention strategy for all studies is to maintain close interaction with both patients and the primary care provider. We ensure patients feel valued, are kept informed.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Find Patients & Fill Trials

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- Service Details

Our team focuses on narrowing the gap between patients and clinical research by reaching out to physicians and their patients and helping them participate in clinical trials.

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Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Solid Organ Transplant Solutions

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The OTTR CompleteOrgan solution simplifies data collection, patient tracking and data management. Our software includes liver, kidney, pancreas, heart, lung, intestine and islet cell transplant solutions.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

BioVisualization

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- Service Details

Our BioVisualization service is designed to query our clinical sample databases in real-time, so your most current data is being examined. The figures are downloadable for ease of sharing with colleagues and incorporation into reporting documents.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Strategic Regulatory Services

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- Service Details

Our regulatory consulting team serves clients around the globe from biotech startups to big pharma as well as the research, investment, and legal firms that serve them.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Boost Patient Enrollment

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- Service Details

Traditional methods of increasing enrollment are expensive and inefficient. SubjectWell’s recruitment marketplace helps you find the right candidates faster so you can stay on schedule, avoid risky spending on recruitment, and get to market faster.

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Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Clinical Trial Management System (CTMS) Softw...

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- Service Details

A Clinical Trial Management System (CTMS) is a software solution targeted for the Life Science industry. CTMS is commonly used to manage processes and large amounts of data involved with clinical trial management and clinical study management.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Device Studies

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- Service Details

Quorum understands the complexities of device research. Our boards have extensive experience with devices, our regulatory team can help determine the appropriate classifications for your product, and our support staff can guide you through the particulars of reviewing device research.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

Pharmacovigilance & Safety Reporting

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- Service Details

We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.

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Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Regulatory Services 

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- Service Details

We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Cryoport Express® Dry Shippers

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- Service Details

For materials that need to be kept at frozen temperatures, Cryoport’s signature Cryoport Express® dry shippers are the most advanced storage and shipping containers on the market.

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Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

Periodic Benefit-Risk Evaluation Reports (PBR...

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- Service Details

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

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Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Product Development Consulting

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- Service Details

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Human Repeat Insult Patch Test (HRIPT)

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- Service Details

To determine the safety of topical products, RCTS provides a range of clinical testing procedures, including a broad range of in-use and patch studies. Human repeat insult patch tests (HRIPT) for contact sensitization/irritation and acute or cumulative patch tests irritation.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

Clinical Development Services & Solutions

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- Service Details

Chiltern provides the following services for Phase lllb - IV Post-marketing Late-stage programs: Post-approval GCP studies, Disease, product and pregnancy registries, Epidemiological studies, Restricted access and compassionate use programs, Retrospective and chart extraction studies, Risk

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

ClinPlus® Data Management

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- Service Details

ClinPlus Data Management (CPDM) software, our classic data management system designed to support paper-based studies, has helped clients manage clinical studies across multiple therapeutic areas and collect quality data while meeting strict timelines and budget constraints.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Molecular Imaging and Radiochemistry

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- Service Details

Radiochemistry and advanced preclinical and clinical imaging research services

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Regulatory Affairs

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- Service Details

We always ensure we are in line with the latest regulations and compliance guidelines. We thoroughly assess participant safety and ensure that the participants are committed and motivated to complete their study.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Enrolling Participants for Your Study

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- Service Details

When you place a study with Spaulding Clinical Research you have access to a team of recruitment experts, who are dedicated to enrolling participants for your study. Our recruitment metrics show that our team delivers and they do it on budget.

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Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Clinical Evaluation Report (CER)

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Factory has an expert team of medical writers that has this knowledge and experience and that can help you compiling these reports making sure you do it right the first time so you don’t loose time and resources.

Virtual Booth Transforming Drug Development with Science & Innovation.

American DDF Summit

Rapid Subject Recruitment

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- Service Details

Quotient has the experience and expertise to deliver studies with the highest quality service and speed to clinical data. If you need a complete service including data management, data analysis, statistics and medical writing, Quotient is your answer.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Goes Direct Approach

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- Service Details

Our team Goes Direct with an approach that redefines the clinical trial process — finding and identifying patients for studies, then providing their physicians with the personnel, processes, technology and infrastructure to conduct them in their own clinics.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

Patient Recruitment & Clinical Site Partnersh...

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- Service Details

We understand potential obstacles to recruitment and recognize the importance of a well-outlined recruitment and retention plan developed in conjunction with the study protocol.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Cold Chain Logistics

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- Service Details

CSM has an extensive list of available packaging, labeling, storage and distribution services for your temperature-sensitive products worldwide.

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Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

Hematopoietic Cellular Therapy Solutions

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- Service Details

With the growth of next-generation therapies, you’ll need a software solution that keeps pace with evolving regulatory requirements. Our cellular therapy software includes workflow support for all hematopoietic cellular therapy products.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Combination Product Studies

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- Service Details

Quorum has extensive experience with combination products. Our boards and regulatory teams understand the intricacies of combination product research. We can help determine the correct way to manage your study, and we will apply the proper standards for your product.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

ClinPlus® eClinical Software

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Leveraging our industry-leading ClinPlus® eClinical software platform to manage the trial, ensure data accuracy and implement smart, proprietary algorithms to identify and mitigate risk

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

Premarket Submissions

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- Service Details

Greenleaf Health Inc. offers various services such as: 510(k) premarket notifications; Premarket approval applications (PMAs); Requests for de novo review of automatic Class III classification; Humanitarian use designation (HUD) / humanitarian device exemption (HDE) applications; etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Surpass Your Enrollment Targets

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- Service Details

SubjectWell continuously engages the 96% of Americans who have never participated in a clinical trial. We are already talking to patients near your site who are looking for studies and have relevant health conditions.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Development Safety Update Reports (DSUR)

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- Service Details

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

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Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pragmatic / Adaptive Studies

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- Service Details

Pragmatic studies aim to quantify the risks, benefits and costs of an intervention in routine clinical practice, often helping to inform how a treatment may be applied by clinicians outside of the clinical trial environment.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

PK / PD Modelling & Simulation

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- Service Details

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

Safety-in-Use (SIU) Studies

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- Service Details

To determine the safety of topical products, RCTS provides a range of clinical testing procedures, including a broad range of in-use and patch studies. Determining product safety under normal or exaggerated use conditions.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Patient-Centered Sciences

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Patient-Centered Sciences combined services establish Mapi as the clear industry leader in supporting patients or their caregivers, and offer proven results for accelerated drug development, improved recruitment, increased patient engagement, excellence in patient-reported data, and minimized

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Supporting All Phases of Drug Development

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- Service Details

MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

Clinical Development Services & Solutions

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- Service Details

Chiltern provides the following services for Phase I - lla Patient Studies early stage programs: Protocol feasibility and design, CRF development, Recruitment, Data management, Bioanalytical, Biostatistics

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Clinical Data Management Software LSR Trials

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LSR Trials’ custom database software is used at all sites to manage information flow.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Certified Translation & Language Services

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With more than 300 drug products and vaccines currently in clinical trials, TransPerfect's expertise in medical and life science translation and language services provides the quality, efficiency, and reliability necessary to compete in this fast-paced industry.

ERT

  • FDA

Patient Engagement

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- Service Details

Optimize study power and achieve maximum enrollment, retention and compliance with our patient-centric design, tailored patient outreach and automated BYOD technology.

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Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Postmarketing Surveillance (PMS)

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Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts.

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Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Phase I Clinical Research Facility

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- Service Details

With a highly focused staff/subject ratio, custom-designed facility for cardiac safety, and enhanced data collection processes, Spaulding Clinical is truly in a class of its own.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Late Phase Partnerships

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- Service Details

PAREXEL's Peri/Post-Approval Services group of experts are dedicated to late phase research, offering a proven partnership model designed specifically for Late Phase.

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Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Orthotopic Models

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- Service Details

At MI Bioresearch, we work closely with you to determine the most relevant imaging modality for the question you are trying to answer.We offer highly reproducible orthotopic models for many tissue types.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Data Management

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- Service Details

At LabConnect, we’ve combined these processes with a state-of-the-art data management platform ensuring delivery of clean data according to your exact specifications. Upon study award, we will establish your global data and information management plan.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

DocXtools

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- Service Details

DocXtool for Life Sciences is a Microsoft Word toolbar that accelerates the creation, review, and formatting of your electronic common technical document (eCTD), helping get your documents submission-ready faster.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Global Post-Approval Services

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- Service Details

Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Standard Dry Vapor Shipper / Combo Dry Vapor ...

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- Service Details

From point of origin to destination, Cryoport provides easy ordering, fulfillment, shipping, continuous tracking and monitoring, documentation assistance and 24/7/365 customer support for your complete cold chain logistics needs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

Patient Engagement Plans

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- Service Details

The Patient Engagement Plan places the patient at the centre of the clinical trial’s preparation and management. Each plan is different, tailored to the specific circumstances of the patient community within the chosen country.

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Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Virtual Booth Transforming Drug Development with Science & Innovation.

American DDF Summit

High-Quality Regulatory Submissions

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- Service Details

Quotient has an in-depth understanding of the evolving clinical trial regulatory environment in Europe and the U.S., ensuring the production of high-quality dossiers and a seamless submission and approval process for Phase I clinical trial application.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Specimen Logistics

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- Service Details

Logistics management plays a pivotal role in both the execution of laboratory services.Prior to the enrollment, our team will evaluate the investigator site list and determine if specific locations should be subject to a logistics dry-run shipment.

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Clinical Trial Supplies

Supporting All Phases of Drug Development

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- Service Details

MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Clinical Project Management

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- Service Details

With custom solutions for early- and late-phase clinical trials and a team of highly experienced project managers, DZS Clinical Services ensures that your projects are completed on schedule and within budget while complying with international quality standards.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Quality Assurance

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- Service Details

When contracting with LSR Trials, you can be assured that we will meet all deadlines and the data will be immaculate to ensure a successful trial.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

Label Design & Production

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- Service Details

Whatever your labeling challenges are, CSM can meet your exact protocol needs by providing unique and customizable solutions. We work with each client to aid in text creation and product design while ensuring patient compliance.

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Packaging Design & Development

High Volume Dry Vapor Shipper

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- Service Details

From point of origin to destination, Cryoport provides easy ordering, fulfillment, shipping, continuous tracking and monitoring, documentation assistance and 24/7/365 customer support for your complete cold chain logistics needs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

Interpreter Services

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- Service Details

Consecutive & escort interpretation, simultaneous/conference interpretation, remote/over-the-phone interpretation

Drug Safety Solutions Consultation

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- Service Details

Covigilant’s experts provide strategic advice and risk management services in a broad range of areas for your safety-systems-related operations.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Recruitment that’s Different

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- Service Details

Traditional trial recruitment methods look for patients with a particular health condition who happen to live close to a specific clinical site. This is targeting a needle in a haystack. At SubjectWell, we engage the entire haystack – the 96% of people who have never participated in clinical

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Epidemiology

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- Service Details

At PAREXEL® we have senior Epidemiologists, and Statisticians, who have many years experience within the pharmaceutical industry providing solutions to the questions faced by our clients.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Planning & Project Management

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- Service Details

Initially, our feasibility team develops the Synexus Delivery Plan. This provides an accurate assessment of how we plan to deliver the study with full protocol compliance, based on a medically evaluation of the protocol and any potential obstacles.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Clinical Development Services & Solutions

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- Service Details

Chiltern provides the following services for Phase llb - III Late-stage programs: Protocol feasibility and design, CRF development, Recruitment, Data management, Medical writing, Biostatistics, Drug safety monitoring committees

- Directory Listing

Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Active Recruiting Database

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- Service Details

On average, Celerion screens more than 2,300 subjects per month. This success rate is attributed to our experienced staff, our extensive recruiting efforts and our ability to understand both the study requirements and the local subject pool for each of our clinical facilities.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

ERT

  • FDA

ERT eCOA

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- Service Details

We built more than 40 years of scientific and technical experience into our eCOA environment. Streamlined workflows and regulatory adherence make ERT eCOA easy to use with less burden for both sites and patients.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Goes Direct Approach

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- Service Details

The Goes Direct approach allows you to focus on your patients and keeps them under your direct care.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Phase I EDC Solution

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- Service Details

Spaulding Clinical offers a fully integrated, paperless Phase I EDC solution that redefines efficiency.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Metastasis Models

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- Service Details

The genes and proteins involved in metastasis have long been sought after as potential therapeutic targets. Our tumor portfolio contains a number of proprietary, efficient, and reproducible metastasis models.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Informed Consent for the 21st Century

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- Service Details

Imagine an eConsent solution that improves compliance and consent accuracy and provides an IRB-integrated process that activates studies in days instead of weeks. Q Consent is the future of electronic informed consent and it’s available now for your research studies.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Pharmacovigilance & Risk Management

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- Service Details

Mapi provides a flexible, global pharmacovigilance service supporting regulatory compliance and management of patient safety issues.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Claims Substantiation & Efficacy Testing

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- Service Details

Claims substantiation plays a key role in a product’s success and helps ensure the product stands out against competitors. From moisturization and barrier function, to anti-aging and color changes, rely on RCTS for your product claims substantiation and efficacy testing needs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

CE Marking

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- Service Details

We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

Monitoring for Clinical Phases Studies

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- Service Details

We provide standard operating procedure (SOP)–guided study monitoring, auditing, and quality assurance support for all phases and inpatient/outpatient studies at over 50 clinical sites for the biopharmaceutical industry and the National Institutes of Health.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Protocol Design

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- Service Details

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

Interventional Studies

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Evidera’s interventional study team has extensive experience in designing global, regional and single country studies in the peri- and post-approval space, including traditional IIIb/IV studies as well as Extended Access/Open Label Extension, Expanded Access/Compassionate Use, etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Marketing & Promotional Practices

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Greenleaf Health Inc. offers various services such as: Strategic guidance on labeling requirements; Promotional materials; Direct-to-consumer advertising review processnRemediation of untitled and warning letters; Use of social media.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Virtual Booth Transforming Drug Development with Science & Innovation.

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In Silico Modeling & Simulation

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We provide in silico modeling and simulation for all our formulation design and selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutical and pharmacokinetic data, providing valuable insight into the in vivo performance.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

Market Access

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Our expert teams of industry leaders, former payers, policy experts, and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to help you achieve optimal price and access.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Return, Reconciliation & Destruction

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Closing the loop on our clinical services, CSM® manages returned drug accountability, reconciliation and destruction.

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Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Clinical Trial Supplies

Disseminated Models

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We offer more than 50 diff hematologic tumor lines, of both human and murine origin. We bring over a decade of industry-leading experience and expertise in model selection, study design, study execution, image acquisition, and proprietary data analysis.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Protocol Design

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RCTS designs protocols in adherence with International Conference of Harmonization (ICH) and good clinical practice (GCP) guidelines, The research protocol describes in detail how the clinical trial will be conducted.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Overview

Early Development Clinical Research Services

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Program services offered by both clinics range from medical writing, clinical conduct and data management to monitoring, biostatistics and clinical pharmacology.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

SAE / AE Reporting

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Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

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Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Quality & Regulatory Support

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Mapi provides customers with assistance on quality and compliance matters, including pharmaceutical quality assurance, medical device quality systems, and clinical compliance (GCP).

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

Regulatory Affairs Strategy

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The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

eCRF Design & System Configuration

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Supporting Drug Development at Phase III

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MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Clinical Monitoring

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The successful execution of your clinical trial hinges on the people involved day to day.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

OnQ Portal- Track Your Study

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The OnQ Portal™ helps you track your study through the IRB review process, from submission to approval documents

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Biostatistics & Statistical Programming

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Chiltern’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver the high-quality statistical output required for every aspect of drug development including the statistical

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

Data Management & Biometrics

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Data Management and Biometrics at Celerion bridges the gap between medical practice and laboratory science by assessing the safety of drug products to maximize drug effects and minimize side effects.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Data Management & eClinical Solutions

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For each project, we develop a data management plan (DMP) that identifies the study-specific quality control steps that we will take to review the data for accuracy and completeness.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Advisory Services

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Greenleaf’s advisory services include research and analysis of the following potential sources of risk: Marketing authorization; Manufacturing and quality; Promotion; Distribution and supply chain; Pipeline analysis; Compliance status; Labeling; Product safety

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Sliderite™ High Volume Dry Vapor Shipper

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From point of origin to destination, Cryoport provides easy ordering, fulfillment, shipping, continuous tracking and monitoring, documentation assistance and 24/7/365 customer support for your complete cold chain logistics needs.

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Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

E-Clinical Technology Solutions

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TransPerfect is proud to offer Trial Interactive, our 21 CFR Part 11 compliant, web-based e-clinical solution

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Virtual Booth Transforming Drug Development with Science & Innovation.

American DDF Summit

Data Management & Database Programming

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Study database set-up and maintenance, Data Management Plan, data cleaning, coding, query issue and database lock.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Clinical & Medical Imaging

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PPD partnered with VirtualScopics to provide an integrated and seamless clinical and medical imaging offering that spans multiple therapeutic areas and allows clients to realize time and cost efficiencies across all trials.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Clinical Data Management

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The data management process is one of the hallmarks of RCTS. Your data is never unattended as it moves through our system, and sign-off forms are required at every step to ensure complete accuracy.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Overview

Clinical Monitoring

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One of the services that distinguish us from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts in different clinical fields who can provide monitoring of clinical procedures so that you can verify that your device is used as you intended.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Clinical Supplies & Consulting

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No matter how complex your clinical supplies problems are, our experienced consulting team has the expertise and background to ensure a smooth supply process.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Clinical Development Document Management

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Trial Interactive is the all-inclusive source for all of your clinical data management needs. In addition to hosting clinical trial solutions and electronic case site solutions, we also provide a full array of scanning and clinical document management services.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Preparation & Submission of CTA/ITA, IND, PMA...

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The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

Pharmacokinetics / Pharmacodynamics (PK/PD)

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- Service Details

Celerion’s team of clinical pharmacologists has extensive expertise in PK/PD data assessment and consults with clients on the appropriate analytical approach for clinical studies.

CryoMax™ Lab Move Shipper

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From point of origin to destination, Cryoport provides easy ordering, fulfillment, shipping, continuous tracking and monitoring, documentation assistance and 24/7/365 customer support for your complete cold chain logistics needs.

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Pharma Service: Clinical Trials

Category: