On July 21, CROS NT hosted a complimentary webinar on clinical trial data oversight. During this webinar, we reviewed the components of biometrics oversight, assessed various approaches, suggested an effective data oversight strategy, and presented case studies.
The webinar was conducted by:
- Amanda Cross – Country Manager US and Executive Director of Service Strategies, CROS NT. Amanda joined CROS NT in 2018 and oversees all operations and business strategy for the U.S. branch of CROS NT. She also manages the strategy for the Biometrics Optimization Solution helping clients to design and implement oversight strategies and a centralized data approach. She is a biostatistician by background and training having started her career in 1995. Amanda has worked in biostatistics and biometrics operations in both the pharmaceutical and CRO sectors with experience in multinationals as well as small to mid-size companies.
- Antonella Bacchieri – Senior Consultant Statistician, CROS NT. Antonella has worked in the pharmaceutical industry and in Contract Research Organizations for almost 30 years, with extensive experience in biostatistics and data management. As Senior Consultant Statistician in CROS NT, Antonella is responsible for providing statistical consultancy services for multiple clinical studies alongside designing and optimizing existing biostatistical and data management processes to support Business Development.
Continue reading to discover the questions from the webinar’s Q&A session answered by the speakers.
Is it possible to do oversight of the data collection activities of different CROs through their eCRF (with specific access to the different DB)?
Amanda Cross (AC): Monitoring ongoing data collection and cleaning activities through EDC systems is one part of the oversight process and can certainly be done. With studies outsourced to multiple vendors using different systems, it can be more complicated to ensure a consistent approach across studies. Effective oversight by functional experts can decrease the risk of disparate approaches. However, since data collection is only one part of the biometric process, monitoring data collection via an EDC system does not constitute a complete oversight solution.
What are the most common KPIs or metrics related to the oversight?
AC: Some examples include: the number of documents reviewed, % on-time delivery (of reviews, documents, reports, etc), errors or timelines impacted by insufficient review by the oversight team. Metrics for vendors could include resource changes, review cycles, on-time delivery, errors due to insufficient quality control, and other related items.
Can you comment on how to ensure safety reporting in the best way, and how to do this across multiple studies meeting different reporting requirements?
Antonella Bacchieri (AB): This is a technical question and a properly articulated answer would require a long explanation, which is out from the scope of this webinar. In case you are interested to learn more about this topic, we invite you to contact seQure, CROS NT’s sister company that provides pharmacovigilance and quality services.
How does this approach differ from project management?
AC: At its core, project management is about getting things done on time and in control. It balances all of the moving parts and critical path items to ensure timely completion and individual activities and the project as a whole. Oversight is about ensuring activities were done correctly and consistently thus minimizing quality-associated risks.
What is the recommended approach for effective communication between the external consultants and the Company in a project mainly focused on oversight?
AB: First of all, it is important to agree on a communication plan between the two parties at the very beginning of the collaboration. The more detailed this plan is, the more efficient the communication will be.
In the case study that I presented, the communication plan included the following key elements:
- Direct communication among all team members, keeping the two primary contact persons (one for the client company and one for CROS NT) always informed.
- Monthly governance meetings with the objectives to align all participants on the project progress, to update plans, to monitor pre-defined risks, and to allow brainstorming on new ideas.
- Well defined escalation paths in case of issues.
What are the most common risks related to biometric vendors?
AC: Most risks are associated with timelines, quality, consistent and sufficient resources, and communication. Communication risks include those related to effectiveness and issue resolution.
Do you think that your approach will meet the upcoming ISO14155:2020 requirements regarding risk management?
AB: The ISO 14155:2020 standards represent an update of the 2011 document and regard new clinical studies (both pre-market and post-market) for medical devices. They align the requirements for medical devices with the GCPs for medicinal products. One of the updates included in this new document is that risk management should be integrated with the clinical development plan. As the need for CRO oversight is part of the general risk assessment, we would suggest that our proposed approach to the CRO oversight is in line with these new ISO standards.
Learn more about the CROS NT approach to clinical data oversight by watching the webinar recording here.
How many studies were the companies from your case studies performing in parallel?
AC: For my case study, the company had 2-4 studies in 4 development programs. Some were active and some were legacy. For the active projects, the biometrics portions were not all with the same vendor, increasing the risk of non-standardized approaches. For the legacy projects, it was important to standardize the data for easier access.
AB: The company involved in my case study was running 6-7 studies in parallel, in 3 main therapeutic areas. Outsourcing involved several different CROs, and the company was normally using a full outsourcing model, i.e. one CRO responsible for all study aspects, including biostatistics and data management.
How to find such a consultancy?
AC: We would be happy to discuss our approach in more detail and understand how we can best help you with oversight. You can contact us by filling in our website contact form.