Collaborative Model

Central to our mission is developing solutions that will accelerate the development of medicines and get them into the hands of patients who need them. We engage with various likeminded organizations to ensure our solutions are beneficial to the patient community. We rely on Patient Advisory Boards to solicit feedback, gather valuable insights directly from patients and their support networks on a variety of critical clinical study-related issues and opportunities, and co-create solutions that will improve a patient’s experience in clinical research. These advisory boards provide unprecedented insight into improving study feasibility, recruitment and retention, and in understanding patient perceptions and receptivity to current approaches, new practices, and technology solutions used in Clinical Research.

In support of its Initiatives, TransCelerate has a regulatory strategy that is both disciplined and agile. Shortly after its founding, TransCelerate established a Regulatory Council to advise Initiatives on strategies for interactions with Health Authorities. The Regulatory Council supports Initiatives in the planning and execution of regulatory meetings and advises and monitors TransCelerate on policy direction for key Health Authorities as it pertains to the TransCelerate portfolio. This group is the central point of contact for TransCelerate’s regulatory engagement, and it executes key interactions on behalf of TransCelerate topics. While TransCelerate’s regulatory practices may not be novel in themselves, applying these strategies for regulatory engagement in the absence of a company asset is unique. While agencies typically see ideas anchored to a company asset, TransCelerate engages Health Authorities in ideation phases, which serves to promote greater collaboration and brainstorming. Ultimately, this approach gives more opportunity for Health Authorities to influence the development of solutions which have the potential to bring greater efficiency to research & development.

A strategic priority for TransCelerate is to deliver solutions that will reduce the administrative burden of clinical trials and increase the time of actual patient care. To achieve this, understanding the pain points in the delivery of clinical trials from those directly impacted by them is critical. TransCelerate collaborates with Investigators, Site Staff and Site Advocacy Groups (SAGs) to hear firsthand experience on challenges, and their perspectives on how to solve them. Partnering with Global SAGs enables clinical investigators and site professionals to interact directly with our Initiatives to exchange perspectives and experiences on innovative ideas, processes, tools, technologies. This global partnership allows us to gather insights on how proposed solutions would be implemented around the world. The knowledge gained has helped us to promote site sustainability, enhance clinical research effectiveness and more closely align the work of the sites and industry across the clinical research ecosystem.

Together with a broad set of stakeholders in the research community, we’ve identified and created efficiencies around how we conduct research. By engaging and asking for input from researchers and clinical research organizations we’re able to determine opportunities to bring efficiency, innovation, quality and value to the clinical research process. In January 2015, TransCelerate and the Association of Clinical Research Organizations (ACRO) established the CRO Forum. The CRO Forum provides a mechanism for CROs, both ACRO members and non-members, to provide industry input on selected TransCelerate Initiatives. For additional information on the CRO Forum, or to inquire about participating in the CRO Forum as a non-ACRO member, please click here.

TransCelerate partners with many other industry organization and consortia around the world to bring greater awareness of our efforts, discuss common pain points, obtain feedback on various solutions, and explore complementary opportunities. Where appropriate, we also work with standards-setting bodies to accelerate the development or improvement of key data standards for clinical trials. Through continued discussion, we can help each other move the needle and experience research and development that is faster, more informed and efficient.