End-of-Trial Declarations

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product

Safety Surveillance & Predictive Signal Detection

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

Development Safety Update Reports (DSUR)

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

Medical Affairs & Pharmacovigilance

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

As part of our mission of ensuring sound scientific evidence in support of safe and effective products, our team places emphasis on product safety. We offer our clients a flexible suite of pharmacovigilance services during product development.

Risk Management & REMS Strategies

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Our risk management team works in a matrix approach with departments across PPD. Experts in epidemiology, registries and observational studies, regulatory affairs, pharmacovigilance and call center operations provide support to REMS programs.

Safety Surveillance / Observational Programs

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products.

Product Lifecycle Management

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Greenleaf Health Inc. offers various services such as: Strategic guidance on FDA’s regulatory process; All aspects of product development; Premarket review; Postmarket safety requirements; Analysis of the market to identify potential competition.

Pharmacovigilance

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Our global Pharmacovigilance teams have the knowledge of local regulations, standards of care and cultural customs you need to identify and assess risks during your clinical trial — keeping patient safety a top priority. And, we have locations around the world to accommodate your trials wherever

Periodic Benefit-Risk Evaluation Reports (PBRER)

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

Pharmacovigilance & Safety Reporting

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.