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In 2012, TransCelerate BioPharma Inc. was launched as a non-profit organization to improve the health of people around the world by simplifying and enhancing the research and development of innovative new therapies. In the below Q&A, DIA Global Forum Co-Editor for Clinical Trials: Design Tools & Management, Christine Pierre, discusses the non-profit’s initiatives concerning clinical sites and clinical trials with TransCelerate CEO Dalvir Gill.

CP: Many of the TransCelerate initiatives have a focus on improving the site experience. Why as an organization, do you feel this is such an important place to collaborate?

DG: When TransCelerate was founded in late 2012, one of our strategic objectives was to reduce the administrative burden placed on investigator sites by improving how sites and sponsors work together when executing Clinical Trials. Since then, we have released solutions that impact the investigator sites, including the creation of a framework for mutually recognized GCP training and just recently a Shared Investigator Platform (SIP) which will accelerate the identification and recruitment of qualified investigators and reduce the time spent by investigator sites signing into multiple accounts to perform clinical trial responsibilities.

There are many other opportunities to streamline and improve processes and communications between sites and sponsors. We are committed to continuing to identify ways that TransCelerate can improve the site experience.

CP: Can you share the value that the SCRS Site Advocacy Groups (SAGs) have had while you design new solutions?

DG: Collaboration with the SCRS SAGs has been extremely valuable to TransCelerate as our project teams worked to define solutions. By engaging with the SAGs early and often, our teams can appreciate and understand the first-hand perspective, from the sites. Direct input into our site facing projects helps us build solutions that actually work for sites, which also increases the likelihood of adoption at the site level. Too often, solutions are developed by various parts of the clinical enterprise that have site facing implications, but the input from sites is inadequate. We have changed all that thanks to the partnership we have developed with SCRS.

CP: A pain point for many sites has been the burden to create and manage data and information across countless systems for each study and sponsor. How is TransCelerate focused on alleviating these pain points?

DG: We recently launched the SIP, which is a platform specifically designed to reduce the administrative burden on investigative sites. Sites have told us that this administrative burden is taking away from time they could spend on patients in the clinical trials. In order to build a platform that addresses some of this administrative burden, we worked very closely with SCRS. The SCRS Site Advocacy Group for the SIP had significant input and was instrumental in the current design and functionality of the platform. The SAG even went as far as to advise on the optimal look and feel of the SIP down to color and location of certain icons within the system.

We believe the SIP will make a significant difference for sites and enable them to interact with multiple participating clinical trial sponsors through a single point of access. A key benefit of the SIP is the reduction in redundant requests by multiple sponsors for information and training through the shared re-use of site specific information. With the SIP, sites can streamline and manage their information in a central place. Bottom line, sites enter their information once and it’s reused everywhere in the platform.

Sites will have a single user account – just one login and password – that allows them to interact with multiple participating sponsors. The data that’s entered, such as credentials and training history, is used for feasibility surveys and study documentation and it’s also available to all participating sponsors for future study opportunities. This recent r0elease marks just the beginning for the Shared Investigator Platform. Our teams are continuing their diligent work and we look forward to the future releases of the platform in which we will add more functions and capabilities to further promote efficiency for investigator sites conducting clinical studies.

CP: TransCelerate’s Risk Based Monitoring Methodology receives a lot of public attention. What impact has this had to investigator sites, and what are you learning?

DG: Our Risk Based Monitoring (RBM) initiative has already had a broad industry impact. Member Companies have anonymously reported more than 100 planned, completed, or ongoing trials using RBM methods. We are also aware that many non-TransCelerate sponsors and CROs have adopted this methodology. The team continues to refine the RBM methodology, provide technology considerations, define appropriate dashboards and have put significant thought leadership out into the industry. We have had highly encouraging feedback with our approach. We continue to learn from trials who incorporate the methodology and we take those learnings back to continuously improve our methodology and tools.

Once the investigative sites gained first-hand experience and better understood the RBM methodology, some of the lingering misconceptions were quickly cleared up and the feedback now is overwhelmingly positive. The use of streamlined and smart approaches to monitoring benefits us all.

Read Business Wire’s release, TransCelerate BioPharma Launches the Shared Investigator Platform to Revolutionize Communications between Sites and Sponsors.

This article originally appeared in the February 2016 Global Forum.