In the ever-evolving landscape of clinical development, the need for robust evaluation of interim clinical data through Independent Data Monitoring Committees (IDMC) has become increasingly vital. IDMCs play a pivotal role in ensuring patient safety and upholding trial integrity amid the growing complexity of clinical development programs. Independent data monitoring is especially critical in Central Nervous System (CNS) studies due to the challenges noted with proper enrollment of patients, rater variability, and placebo response rates, among others.
Furthermore, sponsors often grapple with a multitude of operational complexities that can significantly impact the success of their studies. These experiences often stem from the involvement of numerous vendors and technology platforms, contributing to a study failure rate that is surpassed only by the field of Oncology. To overcome these challenges, it is imperative for sponsors to select the right IDMC provider who can optimize their clinical research approach.
Here we present a compelling case study where Axio (a Cytel company) adeptly handled service partner transitions and empowered the DMC with the vital information needed to fulfill their critical role.
A clinical-stage biotechnology company developing novel medicines to address CNS diseases was facing significant challenges with their existing vendors for Data Monitoring Committee and Data Management and had concerns over the management and assessment of study data. In their active pursuit of an independent statistical center to provide DMC support for their ongoing studies, the company found Axio to be the chosen partner to expertly navigate this critical phase.
Download your copy of the case study below and discover how partnering with Axio enabled the client to expedite the creation of DMC safety reports, all while upholding the utmost standards of patient safety and trial integrity.
Read more from Perspectives on Enquiry and Evidence:
Sorry no results please clear the filters and try again
FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?
Maria Lundberg on a Holistic Approach to Therapeutics Development
New Ebook: “The Good Data Doctor on Data Submission and Data Integration”
At Cytel, we invite a diversity of perspectives and draw on a variety of talents to create a wealth of possibilities. Click the button to learn about the opportunities at Cytel.
