phases IIIb/IV Interventional Studies
Transitioning from product development to the marketplace merits a variety of research approaches, including additional “traditionally” structured interventional studies to address specific uses and/or populations. These initiatives often are developed within the context of forging new relationships with key providers, opinion leaders and/or payers and, hence require precise and sensitive execution.
Our Late Stage team assesses our dedicated and broader clinical research resources for the specific needs of these critical studies, from design to regulatory support to site recruiting to data management and statistical analysis.
EXPANDED ACCESS AND COMPASSIONATE USE STUDIES
inVentiv Health Clinical's Late Stage team has industry-leading experience in developing and implementing these specialized initiatives designed to ensure at-need populations can continue to benefit from innovative therapies even as they are receiving final regulatory evaluation. By ensuring these studies generate valuable experience data, we can maximize their value for our clients while maintaining a focus on overall safety and patient access.
Our endpoint management team includes registered nurses and clinicians collaborate with our clients to collect critical site information and manage the flow of the event data to the Adjudication Committees.
We work closely with sites throughout a study to rapidly obtain the critical source documents needed to immediately report potential clinical events. Using state-of-the-art online tracking tools to manage the collection and review of event information, the team collaborates with data management and monitoring teams to ensure that all events are reported and documents submitted as quickly as possible.