TransCelerate has been actively monitoring the evolving COVID-19 crisis and we are providing our Member Companies a trusted and collaborative forum to discuss the ongoing disruption to drug development. TransCelerate Member Companies are using this informal forum to voluntarily discuss best practices and various options for addressing multiple drug development matters as the situation evolves. These discussions are helping Members Companies more expeditiously and more efficiently identify possible solutions for difficult problems during these uncertain times, although each company is making its own decisions on how best to respond to the changing circumstances resulting from the COVID-19 threat. There are no current plans for TransCelerate to issue materials related to these informal member-to-member discussions.
We continue to have dialogue with colleagues from PhRMA, EFPIA and other organizations within the drug development ecosystem. During this time of crisis, it is important for all stakeholders to work together to help industry find the best solutions as quickly as possible.
In addition, we are actively evaluating our portfolio of ongoing & future initiatives, and reprioritizing activities to focus on solutions that have the potential to help immediately and in the longer term.
Lastly, TransCelerate BioPharma Inc. will be utilizing its DataCelerate® platform to share Member Company control arm data from ongoing and planned COVID-19 clinical studies, as well as data from past studies in related diseases or patient populations.
Several specific TransCelerate solutions can be referenced by sites and sponsors to support the continuity of clinical trials
- Tools to support centralized trial monitoring: TransCelerate’s Risk Based Monitoring methodology and tools can be leveraged to transition from conventional, onsite monitoring. The model guidelines for targeted, risk-based clinical trial monitoring, ultimately aiming to improve data quality and patient safety. The methodology and tools can be adopted by any size organization and adapted to any type or phase of a clinical trial.
- Tools to support protocol deviation management: With the COVID-19 pandemic drastically affecting clinical trial operations, protocol modifications may be required and there may be unavoidable protocol deviations. To help stakeholders navigate multiple aspects of protocol deviation management, TransCelerate has released a Protocol Deviations Toolkit earlier than anticipated. The toolkit offers clarification of the definition and provides a holistic approach to protocol deviations management, including a process guide, process map, decision tree, and an assessment tool. These tools were developed with feedback from Sites, CROs, and Health Authorities.
- Tools to support issue & risk management: A Quality Management System aims to address quality and monitor and improve performance in complex clinical development-specific environments. TransCelerate’s Risk and Issue Management tools provide a framework to provide end-to-end management of risks and issues and support an effective Corrective and Preventive Actions (CAPA) process.
- Tools to support use of patient-friendly technology: TransCelerate’s Patient Considerations Guide provides insights on patient perspectives and key considerations for using technology in clinical trials. As global health authorities have surfaced that trial participants may not be able to visit the investigational site for protocol specified visits, sponsors may evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit) could be used. The guide provides considerations to aid a sponsor’s decision to use technology with patients to help in the current environment.