Shared Investigator Platform Making Life Easier For Clinical Investigators

Contributed by:

Bhaskar Sambasivan, VP, Global Markets Leader, Life Sciences and Beenu Kapoor, Senior Director, Cognizant Business Consulting, Cognizant

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

Life sciences companies are under continual pressure to reduce clinical trial costs and the time it takes to bring a new therapy toPV0616_BhaskarSambasivan market. Clinical trial challenges include subject retention, medical adherence, and managing the huge volume of administrative documents and tasks required of investigative sites. The administrative work necessary for startup and management represents approximately 30% of the activities required for any given study.

Individual biopharma companies have attempted to address administrative inefficiencies by using web-based portals to streamline information flow, document exchange, and data access among study teams and investigative site staff. It is well recognized that investigators complete the same administrative documents every time they work on a study for a sponsor.

What’s more, clinical trials increasingly require dynamic, interdependent relationships among sponsor companies, investigators, and regulators — relationships that must be better managed to increase study efficiency and productivity.

Finally, new technologies ranging from social media to smartphones offer new capabilities that offer the opportunity to influence the clinical trial process and reshape the study experience for patients and investigators.

The Future Built on a Shared VisionPV0616_BeenuKapoor

To address these efficiencies and enable greater collaboration, Cognizant, in partnership with TransCelerate BioPharma Inc., has built the Shared Investigator Platform (SIP). TransCelerate is a nonprofit industry group composed of the world’s leading biopharmaceutical companies, and formed with the vision of accelerating and simplifying the research and development of innovative new therapies. Owned, hosted, and supported by Cognizant, SIP was launched in January 2016. SIP provides a common workspace to simplify the clinical trial process, enable sponsors to collaborate more effectively with sites, and share data and clinical trial information between a sponsor and its clinical sites. The platform is designed to provide a faster, more cost-effective means to manage clinical trials by improving interactions between sponsors and investigators.

The SIP is the first multi-tenant, single sign-on platform through which clinical trial information, operations, administrative documents, and tasks can be shared among sponsors and their sites. Several TransCelerate member companies and investigators developed the features that inform the design and development of the shared platform and provided oversight to ensure the platform provides an intuitive user experience and delivers the right functionality.

The vision for SIP is to enable a true working partnership across all stakeholders aligned with a common goal, making it easier for the investigative site to conduct clinical trials. SIP fosters a community for support and mentoring, as well as the promotion of frequent and just-in-time communication for investigative sites and their staff.

A shared platform, such as SIP, can:

•    Strengthen the relationships between biopharma companies, investigators and regulators, both online and offline.
•    Support near real-time communication between investigators and sponsors.
•     Improve the investigative site experience.
•     Simplify and optimize clinical trials.
•     Streamline access and integration of clinical trial data.
•    Create collaborative solutions across stakeholders focused on efficiency and value.
•     Increase data reliability, transparency and regulatory compliance.
•     Improve efficiency and scalability.

It is critical that platforms designed to support more collaborative and communicative trials offer the scalability and open design required to integrate new technology developments. SIP will continually evolve as technology advances to support the best, most efficient practices for streamlining clinical trials. The vision is that biopharmaceutical companies and sites will reduce time and cost on administrative tasks. At the same time, communication and collaboration between a sponsor and its sites, as well as data accuracy, should improve. SIP is driven by a shared vision for optimizing clinical trials to help the industry meet the demand for less expensive, more effective therapies, in a timely manner.

To download a PDF of the accompanying white paper, please go to: (PV)

Cognizant is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world’s leading companies build stronger businesses.
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