US and European regulators agree, trial design needs stripping back to collect only the right data to answer the critical questions (3,4).
Risk-Based Monitoring (RBM) requires high-quality expertise up front.
RBM is about so much more than source data verification, but people cling to what they know.
Identifying the Key Risk Indicators for each trial enables everyone to focus on what is truly important. Core competencies identified for risk-based monitoring (RBM) indicate that a breadth of development experience is vital.
• People with the right skills
• Correct and adaptable processes
• Appropriate enabling technology
With >50 years' combined experience of clinical development across multiple functions and >20 years of investigating risks to clinical trial quality, Wider Perspectives is ideally positioned to help with your quality oversight.
• 16 mock EMA/FDA sponsor inspections over the last 5 years
• Over 400 assignments globally 2007-2014
• Experience spanning >50 countries worldwide
Skills: When focussing on outliers and data trends you must keep an open mind - they may be correct! Investigations should let the evidence speak - "think like an auditor!" Wider Perspectives has helped others to do so for over 12 years.
Processes: There are many approaches to centralized-monitoring - all will continue to evolve. Processes must adapt to remain fit-for-purpose. Wider Perspectives is pleased to share its experience gained from audits and inspections across companies of all sizes from around the world.
Technology: Working with the right partners is key. Wider Perspectives has teamed with Triumph Research International in developing their clinical quality oversight platform, Visual OPRA.
"Together we aim to show you where you are going, not where you have been...!"
"You didn’t just do what we needed, you hit it out of the park! (To use a baseball/cricket analogy). Everyone here is just amazed at the depth of miscommunication and lack thereof [between sponsor and vendor], and now it’s cleared up." Senior Director, Quality Assurance, US-based Pharmaceutical Company
1. TransCelerate BioPharma Inc. Position Paper: Risk-Based Monitoring Methodology. May 2013.
2. Rosenberg MJ. Key Considerations in the transition to risk-based monitoring. Therapeutic Innovation & Regulatory Science 2014;48:428–435.
3. European Medicines Agency. Reflection paper on risk based quality management in clinical trials. August 2011. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf
4. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring. August 2013.
5. Wilson B, Provencher T, Gough J, et al. Defining a central monitoring capability: Sharing the experience of TransCelerate BioPharma’s approach, Part 1. Therapeutic Innovation & Regulatory Science 2014;48:529–535.
Available at: http://dij.sagepub.com/content/48/5/529.full.pdf+html
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