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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

Pharmaceutical Product Development, LLC

Prorelix Research

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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.

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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: 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

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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

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PAREXEL® has provided world class Late Phase services for over a decade. This is why we know this part of your journey so well. We helped plan it.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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ProRelix Research's dedicated clinical trial project management team provides high-principled, smooth running of clinical trial operational services from Phase I to IV in India, USA, Europe and UK.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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We provide end to end services on clinical trial: Early Phase Trials – Phase I & Phase II, Late Phase Trials - Phase III & Phase IV. We are providing solutions for Early & Late Phases trials with our hospital network across India & abroad.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Azidus offers preparation of regulatory dossiers for semi-regulated & regulated markets, preparation of dossiers in CTD format for Market Authorization in various countries, review & preparation of all modules of CTD for regulatory submission.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Cliantha Research has robust expertise in conducting phase I IND to phase IV for various therapeutic areas like oncology, dermatology, immunotherapy, cardiology, diabetology, psychiatry, ophthalmology, etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Clinical trials are integral part of Drug Development. ICBio CRO offers end-to-end services for Phase II to IV clinical trials on small molecules, large molecules and medical devices with fully ICH GCP compliant operations.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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