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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.

Clinical Development Services & Solutions

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

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

Premarket Submissions

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

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.

Marketing & Promotional Practices

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

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.

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.

Supporting Drug Development at Phase IV

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

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

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.

Phase lllb-lV

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

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.

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.