If your company has used Cetero Research’s Houston facility to conduct bioanalytical studies between April 1, 2005 and June 15, 2010, your marketing applications may need to be repeated or confirmed. By now, you should have received a letter from FDA asking that new bioequivalence studies be conducted, or if there is supporting stability of the analyte throughout the entire frozen storage period, that samples from the original BE studies be re-assayed.
The week, FDA further clarified their requirements regarding studies conducted at Cetero during the aforementioned time frame as follows:
- April 1, 2005, to February 29, 2008: Studies that were previously submitted as part of an approved or pending application, or studies that will be submitted as part of a new application, will need complete reanalysis (if adequate stability data exist) or repeat of the study.
- March 1, 2008, to August 31, 2009: The Agency will accept studies for submission and review if the sponsor performs an independent third-party data integrity audit using the Bioanalytical Electronic Raw Data Audit Plan (provided by FDA). Further, studies that were previously submitted as part of an approved or pending application will also need verification of data integrity by an independent third-party audit.
- September 1, 2009, to June 15, 2010: The Agency will accept studies for submission and review without reanalysis, repeating, or further audit by Cetero or a third party.
The Weinberg Group, a globally recognized regulatory and scientific consulting firm headquartered in Washington DC, has experience helping pharma companies in these matters. We were, in fact, a key player in remediating the similar MDS Pharma Services crisis at their Montreal facility in 2007, helping our clients prevail with minimal disruption to their organizations and supply chains.
If you are in need of our assistance, please do not hesitate to contact Jeff Antos (202.280.0815) immediately.
With the release of the ‘Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring’ in August 2011, a significant amount of industry buzz continues to surround this topic. The guidance encourages sponsors to tailor monitoring plans to meet the needs of the clinical trial in an effort to potentially eliminate the current industry standard of performing 100% source data verification at all clinical sites. The growing consensus is that risk based monitoring will allow sponsors to monitor clinical trials more effectively by focusing on the most significant critical data points. Study parameters, including but not limited to protocol size, phase, complexity, clinical complexity of the study population, geography and experience of clinical investigators, will be of the utmost importance when creating the monitoring plan for the trial to adapt to the new trend.
There are many different approaches to risk based monitoring; however, to proactively ensure overall quality, significant risk assessments will need to be made at the beginning of protocol development, including the determination of the complexity of the trial and the overall experience of the clinical team. This will require significant forethought, such as the experience of clinical monitors, who may require additional training as the direct line of communication to the clinical sites. Additionally, determination of what methodology will be used during the review process will be instrumental, as this will not only be used to assess the sites’ performance but also the monitors’ performance.
The overarching questions still remain for many sponsors. How do you know when risk based monitoring is right for your trial? Will it be effective and adequate to fit the needs of your clinical program? And how do you ensure quality, integrity and safety in doing so? Will the discovery of adequacy or failure of this monitoring approach occur in real time or at the time of conducting your routine GCP audits? Will that be too late?
Posted by Amy Hansen, Director, GCP Services. For more information, please contact Amy at firstname.lastname@example.org.