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Premarket Preparation

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

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.

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Interventional Studies

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

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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Pharmacokinetics / Pharmacodynamics (PK/PD)

Clinical Trials >> Clinical Development / Phase IIb-IV >> Pharmacokinetics / Pharmacodynamics / Pharmacometrics

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.

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Phase IV Monitored Trials

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

Phase IV monitored trials collect data to address issues that support product success in a real-world clinical practice. With our extensive Phase IIIb-IV experience, PPD designs and executes Phase IV monitored trials.

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Phase II And Phase III Clinical Trials

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase II / III

At Nutrasource, we combine clinical expertise in the areas of nutrition, nutraceuticals and pharmaceuticals, as appropriate, to manage trials efficiently and effectively to support product investigations in support of a successful product launch.

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Human Repeat Insult Patch Test (HRIPT)

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase II / III

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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Clinical Development Services & Solutions

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase II / III

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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PK / PD Modelling & Simulation

Clinical Trials >> Clinical Development / Phase IIb-IV >> Pharmacokinetics / Pharmacodynamics / Pharmacometrics

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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Biosimilars

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami and Nottingham.

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Non-compartmental PK & PD Analysis

Clinical Trials >> Clinical Development / Phase IIb-IV >> Pharmacokinetics / Pharmacodynamics / Pharmacometrics

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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