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High-Quality Regulatory Submissions

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Device Studies

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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

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Strategic Regulatory Services

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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

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Global Regulatory Affairs Services

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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

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Regulatory Affairs

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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

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Regulatory Outsourcing Services

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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

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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

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Regulatory Services

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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

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Product Development Consulting

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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: Consulting Services

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Modeling & Simulation

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We provide modeling & simulation for all our formulation design & selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutical & PK data, providing valuable insight into the in vivo performance of molecules & formulations.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Goes Direct Approach

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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

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Combination Product Studies

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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

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Pragmatic / Adaptive Studies

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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

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Quality Assurance

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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

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Drug Safety Solutions Consultation

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

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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CE Marking

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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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

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Quality & Regulatory Support

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- Service Details

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

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Regulatory Affairs Strategy

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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: Regulatory Affairs

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Protocol Design

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- Service Details

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

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Advisory Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Market Access

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- Service Details

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

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Investigator Training & Support

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- Service Details

If investigator training meetings are required, LabConnect will send a PM to your investigator training meetings in the regions you designate. A detailed laboratory manual will be developed based on the protocol and may be translated upon your request.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

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

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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: Quality & Compliance

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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

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Modeling & Meta Research

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- Service Details

Evidera’s expert team of scientists, modelers and statisticians has developed hundreds of simulations, statistical models, and literature reviews to support reimbursement, market access, and internal decision making in all major therapeutic indications and across all major markets.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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International Clinical Trial Rescue

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- Service Details

We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Regulatory Policy Guidance

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- Service Details

Greenleaf Health Inc. offers various services such as: Analysis of FDA policies and processes; User fee requirements; Advisory committee analysis; Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Interaction with Regulatory Agencies World-Wi...

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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: Regulatory Affairs

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Medical Device Evaluation

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- Service Details

The medical device expertise available at MPI Research offers pharmaceutical and biotechnology companies leading-edge experience, efficiency, and precision.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Quality Assurance of Trials

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- Service Details

Our long experience in validating clinical studies has allowed us to strengthen internal procedures to maximize accountability, systematic feedback, and quality control in all aspects of studies and data handling.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Medical Device & Diagnostics

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- Service Details

We have an exceptional depth of knowledge in cardiovascular, ophthalmology, oncology, orthopedic, respiratory and women’s health applications of medical devices. Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Simplify Study Design

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- Service Details

During study design, it’s critical to to optimize protocol design and global placement to achieve predictable delivery and avoid amendments that slow the process. After all, 55% of trial delays happen at the site level[1], which can have a cascade effect downstream. PAREXEL's ForeSite™

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design