Newsletter | November 10, 2022

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


Welcome to the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & ComplianceUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Regulatory & Compliance
Tips For Your Virtual Meetings With The FDA

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.

Fast Track Designations For Your 505(b)(2) Drug Development Program

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.

Similarities And Differences Between The CTA And IND

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

Quality Metrics: How To Add Value And Meet The FDA's Expectations

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.

Local Affiliate Product Services

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

Medical And Regulatory Consulting

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.

Outsourcing Models
What Is A Risk-Based Approach To CRO Oversight?

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?

How To Optimize Clinical Supply Chain Management

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.

Are You An Emerging Biotech? Things To Consider When Selecting A CRO

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

Strategically Controlling Clinical Trial Costs: 5 Big Takeaways

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.

5 Ways SuiteSuccess For CROs Helps Grow Your Business

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.