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Phase IV studies are required post market approval. These might be single country marketing studies through to large global observational trial studies. Clinical monitoring is done for the safety related aspects as well as data integrity validation of clinical trials by pharmaceutical companies. Technologies, such as EDC and e-PRO, are utilized and offer expertise when developing the trial and defining patient and visit numbers to ensure statistical relevance. CRO’s not only provide complete ran

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Azidus Laboratories

Chiltern International Ltd

Cliantha Research

Dalmia

Evidera

Greenleaf Health Inc

ICBio Clinical Research Pvt Ltd

MPI Research Inc

PAREXEL International Corporation

PPD

Prorelix Research

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INDIA

UNITED KINGDOM

UNITED STATES

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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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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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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

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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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

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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

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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

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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: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

PPD

  • FDA

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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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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV