The benefits of a shared platform that exponentially increases collaboration between sponsors of clinical trials and research sites are helping the industry to match the supply of investigators with the demand for greater speed and increased scalability.
Perhaps the most profound change that the digital age has delivered is the ability to share. However, decades of progress in information technology reveals our constant struggle to balance the benefits of sharing with our desire to maintain control.
We cheered the arrival of mainframe computers as they enabled the sharing of information previously locked in metal file cabinets; later, we fell in love with the personal computer because it gave us more control. As we moved from individual PCs to those connected in local- and wide-area networks, it seemed we had found the ideal compromise to balance sharing and control.
Sharing is Here to Stay
The Internet awakened us to the benefits of sharing information within and outside of the boundaries of a corporation, aided by collaborations and standards. This commitment to collaborate and share has provided more independence, broader choices and greater efficiencies than we could have ever imagined.
Collaboration, efficiency and choice have been the guiding principles of TransCelerate Biopharma, Inc.’s initiatives since its formation in 2012. Not surprisingly, the concept of sharing is baked into the name of one of its largest initiatives: the Shared Investigator Platform (SIP). The sponsor companies adopting this initiative understand the value that a shared common platform brings to them, the site, and to clinical research as a whole.
Shared Objectives Brought to Fruition by the SIP
When it comes to relationships with sites, sponsors of all sizes share common objectives:
To find the most appropriate and competent sites for a given study.
To initiate and execute studies as rapidly and economically as possible.
To make participation in trials as easy as possible for site staff and patients.
To continually expand the available clinical research pool of investigators.
The multi-sponsor platform consists of building blocks that enable each and every sponsor to achieve these objectives. Itprovides360-degree collaboration across trial resources — to sites and sponsors alike — and unites existing clinical systems from multiple vendors in an open architecture (see Figure 1).
Solving the Problem of Proliferation
While digital systems have delivered on the promise of paperless trials, the benefits are being erased at the site level, ironically, by the proliferation of these systems. Sites consistently report that the number of usernames, passwords, systems and interfaces needed to manage per sponsor reduces their willingness to work with new sponsors. This increasingly limits access to patients and delays the startup of trials.
The promotion of investigator portals by individual sponsors as one-stop access to all resources needed to perform clinical trials doesn’t ring true for many sites. In their eyes, every pharmaceutical company-specific portal represents a myopic view of a sponsor’s universe, with redundant log-ins, training courses, user and facility profile requests, and a host of clinical applications from a variety of vendors. Collaboration and standardization across all sponsors are the only way to transform pharma from the inside out.
A Multi-Sponsor Solution Gives Sites Visibility
The SIP elevates the sites’ perspective by giving them the exposure and visibility needed for the industry to match the supply of investigators with the demand for clinical trials – with speed and at scale. The results are increased engagement and efficiencies across clinical development resources:
Study start-up is accelerated, because both sponsors and sites contribute and have access to a single repository for profiles, CVs, and mutually recognized training courses and records.
Administration burden is reduced, because processes to develop and distribute feasibility studies, clinical documents and safety notifications are shared.
Site personnel have more time to spend with patients and provide higher quality data, because they have the ability to manage tasks and workload across multiple sponsors.
By joining the platform, sponsors eliminate the expense of developing, maintaining and supporting company-specific portals. They also reduce their own administrative burden created by disparate processes and tools used by sites to manage multiple trials and multiple sponsors.
A Single Sign-On Accesses a Multi-Vendor Environment
Single sign-on might sound like a simple concept, but it is actually a complex function to achieve across the clinical research ecosystem. The SIP provides identity, credentialing and access management. Single sign-on access into all core functionality, as well as study-specific, sponsor-specific clinical systems, as enabled by each sponsor, eliminates the need for site personnel to create and remember dozens of user ID/password combinations for multiple sponsor portals and systems.
Staying true to the vision of TransCelerate, the SIP makes it easy for individual sponsors to connect and enable the use of established or new study-specific systems from their vendor of choice, including those for electronic data capture (EDC), interactive response technology (IRT), electronic patient-reported outcomes (ePRO), drug safety systems and others. SIP’s study workspace provides secure, compliant, one-click access to all appropriate resources, significantly reducing the administrative burden on sites and the support requests made to sponsors.
Reversing Unintended Consequences
Is it time for your company to help reverse the unintended consequences of system proliferation and trial fatigue at investigative sites? The SIP is gaining scale and is the only solution that will reduce the administrative burden on sites, speed study startup and increase efficiencies for all clinical trial stakeholders.
This article originally appeared in PharmaVoice and was written by Beenu Kapoor, a Senior Director in Cognizant Consulting’s Life Sciences Practice. Listen to Ms. Kapoor talk about Cognizant’s Shared Investigator Platform, how it ties in with TransCelerate members, the qualitative and quantitative benefits of sponsors and sites using the platform, and interesting trends seen while at DIA in the following video.
Cognizant was chosen by TransCelerate in 2014 to develop, host, maintain and support the Shared Investigator Platform. 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.