For years, TransCelerate’s Member Companies noted that clinical trial Sites were heavily burdened by using many different platforms, each requiring unique login credentials, to perform clinical trial responsibilities and communicate with their Sponsors. In addition to the high costs and redundant efforts involved in developing and maintaining individual Sponsor portals, the existence of disparate processes and tools within these portals increased both risk of error and support needed for Site Users.
The Shared Investigator Platform (SIP) was built as a cross-industry solution designed to address these challenges and ultimately enhance efficiency during clinical trial planning and execution. TransCelerate Member Companies that choose to adopt the SIP can increase engagement with investigative sites and eliminate the need to develop and maintain company-specific portals. Additionally, the system will allow expanded insights to clinical trials for regulatory bodies. The SIP is offered by Cognizant, and is the only solution in the clinical trial space, designed with Sites and for Sites, which houses multiple Sponsors and allows for integration with other clinical systems.
Benefits for Sites:
- Increased efficiency and reduced administrative burden due to centralized point of access more unified experience, harmonized content and services
- Reduced study startup time and redundant training
- More time with patients due to a decrease in redundant requests for information (e.g., feasibility surveys), Essential Documents, and Training
Benefits for Member Companies:
- Streamlined processes, regulatory compliance and capacity
- Better data quality in Sponsor systems
- Increased intra-company collaboration
Benefits for Regulators:
- Increased efficiency in accessing study data and information about trials
Both participating site staff and the sponsor user can perform study planning, study start-up and study conduct activities in SIP. To learn more about Investigator and Sponsor use of SIP and planned SIP releases, please click to our Initiative Assets.
The Investigator Registry initiative enhances TransCelerate’s Shared Investigator Platform, and accelerates identification and recruitment of qualified investigators, which will avoid duplication of standard site qualification and the creation of investigator documentation, and thereby reducing cost and trial length.
Placebo and Standard of Care Data Sharing
The Placebo and Standard of Care (PSoC) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.
Site Qualification and Training (SQT)
The SQT Initiative collaborates with TransCelerate Member Companies, investigator sites, CROs and health authorities to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites.