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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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CLINICAL SUPPLIES MANAGEMENT HOLDINGS, INC.

Capsugel

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

Litera Microsystems

Lovelace Scientific Resources

MI Bioresearch

MPI Research Inc

Mapi Group

Merck Millipore

OTTR Chronic Care Solutions

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

QUINTA-ANALYTICA s.r.o

Quorum Review, Inc.

Quotient Sciences

Reliance Clinical Testing Services, Inc

Sai Life Sciences Limited

Spaulding Clinical, LLC

SubjectWell

Synexus Limited

TFS International AB

TransPerfect

Trial By Fire Solutions, LLC

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CZECH REPUBLIC

INDIA

SWEDEN

UNITED KINGDOM

UNITED STATES

Virtual BoothGlobal Pharmaceutical Dosage Solutions Company

Specialized Clinical Capsules: Phase I / IIa

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- Service Details

PCcaps® provide a simple way for pre-clinical oral administration of pharmaceutical actives and formulation to rodents.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase I / IIa

Virtual BoothTransforming Drug Development with Science & Innovation.

High-Quality Regulatory Submissions

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- Service Details

Quotient Sciences’ team possesses an in-depth understanding of the evolving clinical trial regulatory environment in Europe & the U.S., ensuring the production of high-quality dossiers, submission & approval process for Phase I clinical trial application.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Virtual BoothTransforming Drug Development with Science & Innovation.

Phase 1 Clinical Pharmacology Study

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- Service Details

Quotient has the experience & expertise to seamlessly deliver your studies with the highest quality service & speed to clinical data. If you need a complete service including data management, analysis, statistics, 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

Virtual BoothDelivering Contract Development & Manufacturing Solutions, through a broad suite of expert capabilities across the molecular lifecycle

Drug Metabolism and Pharmacokinetics

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- Service Details

Sai Life Sciences has been a trusted partner for delivering high-quality In Vitro ADME services to a broad range of innovator clients.

Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

Phase I Clinical Trials & BE/BA Study

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- Service Details

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

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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

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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

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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

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Best in Class Patient Retention

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- Service Details

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.

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Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

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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.

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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

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Clinical Development Strategy

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- Service Details

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

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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

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Clinical Evaluation Report (CER)

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- Service Details

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.

ERT

  • FDA

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ERT Imaging

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- Service Details

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.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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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.

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Solid Organ Transplant Solutions

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- Service Details

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.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

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AxxiTRIALS

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- Service Details

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

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

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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

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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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

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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

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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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

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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

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: