To explore the challenges, opportunities and best practices for assessing and choosing a CRO, you may be interested in watching a recording of a webinar we recently hosted titled, “The Nuts & Bolts of Selecting a CRO.”
Founders provided unique insight on when to bring on new talent and skill sets, when to engage partners, investors and board members and how to recognize the need to evolve as organizations change.
Learn best practices for implementing a Quality by Design approach to remote site monitoring and eTMF compliance and inspection readiness.
In the process of finding a partner and negotiating an agreement, a central question arises: What is my drug candidate worth?
Maren Nelson has developed multiple medical devices during her career. Her projects have included internal and external resources for both the development and manufacturing of new products and product changes. Maren currently consults on medical product development strategy and Quality Management System implementation and improvements.
But successful biopharma partnerships don't happen by chance and negotiating an out-licensing deal can be complex—especially when the company may also be progressing the clinical portfolio.
Recent cutting-edge advances in genetic therapies are likely to provide game-changing treatments, if not cures, for many patients with rare inherited disorders.
GlaxoSmithKline CEO Andrew Witty once commented on the high cost of drug development, saying, “If you stop failing so often, you massively reduce the cost of drug development.” So, why do clinical trials fail, and what can be done about it?
As of May 5, 2017 submission of NDAs, ANDAs and BLAs to the Center for Drug Evaluation and Research (CDER) using the eCTD format became mandatory. For commercial INDs and Master Files the deadline is May 5, 2018.
Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. With so many CROs to choose from, what kind of evaluation criteria should be used?
