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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 range of clinical study management and biometrics for typical Phase IV post approval studies. Retrospective/ prospective chart reviews (single/ multi centre), patient satisfaction surveys, PRO validation, Proof of concept studies are some of the angles in Phase IV studies to validate a product’s performance against a valid competitor in the market. Companies venture into post marketing studies to improve the potential of their product and this has been the fastest growing segment in the area of clinical research. Phase IV studies helps in finding data for new entrants in therapeutic segments and new markets for which the drug was not initially approved. These studies are randomised to improve and maximise the informational value. The Phase IV research environment is driven by the varying regulatory environment, increasing safety concerns of new medicines, and the need for real-world data on the marketed drugs. Phase IV studies have become a key component in the pharmaceutical industry’s product life cycle. This emerging area of clinical research is essential for the pharmaceutical firms to provide initiatives and assistance in areas such as client approvals, company expansion; marketing, New indication studies/labeling expansion, Product/ disease registries, Health-related quality of life, patient-reported outcomes via IVRS, Post-marketing surveillance, Retrospective chart reviews, Managed-care studies, Pharmacoeconomics. Late Phase solution is uniquely positioned to address key areas like Post-authorization safety studies (PASS) / Post-authorization efficacy studies (PAES), Phase IV trials — approved product, same indications (interventional), Registries — disease, product and safety (observational), Community-based and naturalistic studies.Literature-based meta-analysis, Post-market patient registry study and Randomized-controlled, multi-centre clinical trial are some of the major aspects of Phase IV studies. Real world outcomes like Health economic & outcomes research, pragmatic trials, patient reported outcomes, epidemiology data, lactation/placental transfer studies, consumer health studies are also subsets of post approval trials.

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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

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      Premarket Preparation

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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

      Chiltern International Ltd

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        UNITED KINGDOM United Kingdom

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        Clinical Development Services & Solutions

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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

        Greenleaf Health Inc

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          UNITED STATES United States

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          Premarket Submissions

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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

          Evidera

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            UNITED STATES United States

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            Interventional Studies

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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.

            - Directory Listing

            Pharma Service: Clinical Trials

            Category: Clinical Development / Phase IIb-IV

            Sub Category: Phase IV

            Greenleaf Health Inc

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              UNITED STATES United States

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              Marketing & Promotional Practices

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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

              MPI Research Inc

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                UNITED STATES United States

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                Supporting Drug Development at 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

                Pharmaceutical Product Development, LLC

                • FDA

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                UNITED STATES United States

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                Phase IV Monitored Trials

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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

                PAREXEL International Corporation

                • FDA

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                UNITED STATES United States

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                Phase lllb-lV

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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

                Prorelix Research

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                  INDIA India

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                  Phase IV Clinical Research Services

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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

                  Dalmia

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                    INDIA India

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                    Phase IV Clinical Trial

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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

                    Azidus Laboratories

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                      INDIA India

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                      Phase IV Studies

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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.

                      - Directory Listing

                      Pharma Service: Clinical Trials

                      Category: Clinical Development / Phase IIb-IV

                      Sub Category: Phase IV

                      Cliantha Research

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                        INDIA India

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                        Interphex Week Tokyo

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                        Phase I - IV Clinical Trial Services

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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

                        ICBio Clinical Research Pvt Ltd

                        • Audit Compliance

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                        INDIA India

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                        Phase II - phase IV clinical trials

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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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