The Association of Clinical Research Organizations (ACRO) founded the CRO Forum in January 2015 to engage with TransCelerate BioPharma, Inc. The CRO Forum provides a mechanism for CROs, both ACRO members and participating non-members, to provide industry input on selected TransCelerate initiatives. Alan Metz of IQVIA is the CRO Forum Chair, with Amy Kissam of Syneos Health serving as the CRO Forum Vice-Chair.
CRO Forum leadership currently consists of senior representatives from 11 companies. The CRO Forum is supported by working groups made up of subject matter experts from the CRO industry. These working groups provide expertise and feedback on various TransCelerate initiatives. Each working group has a leader who serves as the primary liaison to a specific TransCelerate work stream. The CRO Forum and TransCelerate mutually agree on the projects for which CRO input would be most valuable and practical. The CRO Forum’s engagement with a given TransCelerate initiative does not constitute an endorsement of any specific project, vendor, process or technology.
The CRO Forum is currently engaged in the following TransCelerate projects:
- Risk-Based Monitoring (RBM): The RBM initiative is developing guidelines for a model approach for targeted, risk-based clinical trial monitoring. The current working group leads are Kristin Mauri of Bioclinica and Megan DiGregorio of PRA Health Sciences.
The CRO Forum’s working group conducted an internal survey to take a deeper look at the lessons learned while implementing RBM over the past few years. The group will be presenting their results and analysis at various upcoming industry conferences through mid-2017.
The working group has provided feedback on two of TransCelerate’s recent publications, “Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations,” and “Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct.” Our working group anticipates providing feedback on TransCelerate’s current developments towards the end of 2016.
- Quality Management Systems (QMS): The QMS initiative is working to create frameworks to reduce and resolve recurring quality issues in clinical trials.
The CRO Forum’s QMS working group has provided feedback on TransCelerate’s publication, “Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline.”
- eConsent: The eConsent initiative is working to create a common approach for the electronic patient electronic consent. This is the newest CRO Forum working group, formed in February 2016.
The CRO Forum’s eConsent team provided feedback on a TransCelerate toolkit for Sponsors on eConsent procedures in July. The working group hopes to provide additional feedback on consolidated toolkit and framework documents in December.
- Shared Investigator Platform (SIP): The SIP initiative is developing a single point of access to deliver content to investigator sites. The current working group co-leads are Elizabeth Seyfert of Chiltern and Mike McDevitt of Syneos Health.
The CRO Forum’s SIP working group is made up of two sub-teams, one with technical expertise and the other with an operational focus. The Forum liaisons have been actively engaging with the TransCelerate team and anticipate providing feedback in the future.
- Common Protocol Template (CPT): The CPT initiative is working to create a model clinical trial protocol template including a common structure and model language.
The CRO Forum’s CPT working group provided some initial feedback on TransCelerate’s common protocol template, which was released in January 2016. Effective in early 2016, this working group was deactivated, as our involvement came to a close with the current stage in the life-cycle of the project. The CRO Forum may re-engage on this initiative as the template is adopted more widely in the industry and there comes a time when we can provide meaningful insight.
Membership in the CRO Forum is included with membership in ACRO. For CROs that are not ACRO members, the annual fee to participate is $10,000. For additional information on the CRO Forum, or to inquire about participating in the CRO Forum as a non-ACRO member, please contact Anina Adelfio at firstname.lastname@example.org.