Familiarize yourself with the new FDA draft guidance on blood pressure response which carries important implications for drug developers.
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
Why you should prepare now even with nearly a year remaining.
What can you do during your study to maximize your chances of success when it comes time to submit?
Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
A video overview of the valuable content that can be accessed as a DIA NOW user.
Don't let the complex logistics involved in the handling of clinical supplies in certain regions of the world put your patients at risk or jeopardize both the study budget and timeline.
How technology-based imaging improves quality and regulatory compliance, and how these improvements benefit sponsors.
In this webinar, INC Research/inVentiv Health experts discuss the factors that sponsors must take into account as they design and execute clinical trials in this space, beginning with a review of the immunotherapy landscape.
See how a life sciences organization uses CoSign to securely and compliantly sign an FDA form.
Get your trials up and running faster and your products to market more quickly. Learn how Startup InSite™ technology and the CFS Clinical Contract and Regulatory Services team speeds up the process.
DIA’s Conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to challenges associated with determining study endpoints and outcomes.
The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval.
Contracting an in-country clinical depot helps bring costs and timelines under control.