11.10.22 -- UCB's Approach To Risk-Based CRO Oversight

It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

One FDA tenet is to get safe, effective drugs to market as soon as possible. Understand the details of Fast Track designation (FTD) and how 505(b)(2) products can qualify for this program.

Consider the purpose, content, and procedural similarities and differences between the Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications.

It can be challenging to select the right quality metrics, since quality can be subjective and hard to measure. Explore the types of metrics used to provide assurance to customers and regulatory authorities.

Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies.

Review an interdisciplinary approach that coordinates medical writing, pharmacovigilance, medical monitoring, and central lab services fundamental to the continuity and operational success of clinical trials.

Ian Wyglendowski, head of strategic clinical partnering at UCB, recommends taking a risk-based approach to CRO oversight. The first step is understanding the risk that exists. If an inspector walked in today and asked how you, the sponsor, could ensure that an activity you have outsourced complies with ICH GCP regulations, would you know how to answer?

Sponsors have traditionally lacked the tools to optimize clinical supply chain management and avoid the many pitfalls they face. This playbook explains how a sponsor freed itself from those problems by adopting an eClinical supply chain management platform.

Delve into the understanding of how smaller biotech companies should approach CRO selection and what they should consider before launching their clinical development program.

Ensuring your trial is delivered with the highest quality, on time, and on budget is essential to avoid unnecessary and often required change orders. Build a focus on quality while controlling clinical trial costs.

SuiteSuccess can completely transform the CRO business with resource management and finance. Explore some ways SuiteSuccess also helps you control and build CRO business growth.