TransCelerate BioPharma Inc. today announced the launch of the Shared Investigator Platform (SIP), a technology that will allow clinical trial sites to streamline investigative site information, and establish a central access point for interaction between the site and multiple clinical trial sponsors.
The unique design and development of the SIP was made possible through important partnerships with several key stakeholders. To ensure the investigator site perspective was included in the design of the system, participating TransCelerate Member Companies collaborated with Investigators through a Site Advocacy Group provided through a partnership with the Society for Clinical Research Sites (SCRS). The interface for the delivery of content and services to sites was developed by Cognizant, the overall system integrator and service provider who wasselected to design, build and host the SIP. Cognizant incorporated capabilities by CA Technologies, DrugDev, Exostar, LifeRay and SumTotal each who played a critical role in bringing the innovative vision of the TransCelerate Member Companies to life.
Clinical research sites often have to use written documents, as well as multiple portals or applications requiring separate login accounts to perform clinical trial responsibilities for each sponsor with whom they work. As a result, communication for sites who work with multiple sponsors and across multiple studies has been cumbersome and complex. Moreover, the development and maintenance of individual sponsor portals has made operations unnecessarily costly and time-consuming.
Shared Investigator Platform Initiative Leader Jackie Kent, and Eli Lilly's Senior Director, Product Delivery Supply Planning and Systems, states, "The SIP will help us, as an industry, solve operational R&D challenges common to trial sites and sponsors. With SIP, sponsors and sites will benefit from improvements in study start up or reduction in duplicative work."
Ms. Kent goes on to note, "SIP benefits the patient by reducing the amount of time investigators dedicate to onerous administrative tasks, elevating the focus on the patient experience - a critical element to a trial's overall success and a key strategic priority for TransCelerate. Our ultimate goal at TransCelerate is to ensure that medicines are delivered to patients quickly and safely, and the SIP plays a pivotal role in realizing that."
The Shared Investigator Platform is closely connected to TransCelerate'sInvestigator Registry (IR) Initiative, a shared repository of investigator details. The IR links together profiles from the Shared Investigator Platform with TransCelerate Member Companies' clinical trial management systems, the DrugDev investigator network, public data and other third party sources using the universal identifier, known as the DrugDev Golden Number. The aim of the TransCelerate IR is to provide an evidence-driven approach for accelerating the identification and recruitment of qualified investigators, also providing participating TransCelerate Member Companies with a mechanism to prevent duplication of site qualification activities or generation of investigator documents.
TransCelerate's CEO, Dalvir Gill, PhD, states, "The development of the Shared Investigator Platform was one of TransCelerate's founding initiatives aimed at reducing investigative site burden. The SIP and the supportive Investigator Registry combined should dramatically decrease the administrative burden placed on investigator sites and improve sponsor efficiencies." Several TransCelerate Member Companies have announced plans to adopt SIP and IR in the near term, and the clear benefits from SIP and IR will lead others to adopt future releases in 2016 and beyond. This release marks just the beginning for the Shared Investigator Platform. Future releases of the platform will add more functions and capabilities to further promote efficiency for investigator sites conducting clinical studies.
What Does SIP Go-Live Mean For Research Sites?
The SIP will facilitate and simplify interaction between investigators and multiple clinical trial sponsors. With the SIP, sites will experience:
- Increased efficiency and reduced administrative burden in clinical trial planning & conduct
- Streamlined interactions, and consistent data & processes with participating SIP Sponsors
- Reduction of data entry requirements – the ability to enter data once, and have that data re-used across SIP Studies and Sponsors
With SIP, sites can maintain more meaningful collaborations with Sponsors and investigators spend more time on what matters most - their patients.