TransCelerate BioPharma’s Shared Investigator Platform revamps site/sponsor dynamic to accelerate development of new medicines

By Paul Nicolaus

May 18, 2016 | TransCelerate BioPharma’s Shared Investigator Platform (SIP) Initiative—launched in January—has its sights set on changing the relationship between sites and pharmaceutical companies working on clinical trials. “It is absolutely the first of its kind,” said Jackie Kent, TransCelerate’s SIP Initiative leader.

The goal is to simplify investigative site collaboration with multiple clinical trial sponsors and reduce the administrative load for site staff, which is accomplished by increasing the automation and re-use of data while reducing the number of requests for information. In other words, Kent added, the aim is to become a one-stop shop for an investigator site.                                        

Many of the top pharmaceutical companies in the world are already involved in the action with companies like Pfizer, Roche, Sanofi, Merck, Johnson & Johnson, GlaxoSmithKline, AstraZeneca and Bristol-Myers Squibb on the roster of TransCelerate’s nearly twenty member companies.

New Playing Field

It’s the changing landscape in the healthcare regulatory realm that has allowed this type of cooperation to come to fruition. “The industry didn’t play this way in the past,” Kent said, noting that five or 10 years ago this type of information never would have been shared.

Initiatives geared toward the publishing of protocols and data transparency have opened up this space in such a way that it just doesn’t make sense to make it competitive any longer. “There are very clear requirements from a regulation perspective,” she said, “and it’s really not something you need to be highly innovative to do. What you need to do is to be clear, concise, and effective, so it’s the perfect place to play together.”

Along the way, TransCelerate member companies have worked with Cognizant, the overall systems integrator and service provider, to facilitate a site’s interaction with multiple sponsors and enable study planning, start-up and conduct through a single point of access. 

In bringing together the different products and organizations that are part of the SIP ecosystem and supporting individual member companies who choose to adopt the platform, Bhaskar Sambasivan, Cognizant’s VP of life sciences, indicated that the company has worked to transform business processes in order to bring about efficiencies in clinical trials by honing in on the interactions between sponsors and investigators.

Along the way, Cognizant’s main contributions to the project have included requirements elicitation, design, architecture, development, validation, hosting, rollout and help desk support of the complete platform. 

This role has come along with some hefty challenges, however, such as working with multiple member companies to agree on a common set of functionality so that each company’s unique manner of conducting clinical trials is accommodated. In addition, there is a need to ensure that every product that is part of the SIP ecosystem is well-integrated and functions seamlessly within the agreed upon parameters, Sambasivan added.

Vendor Solutions

Led by several of the member companies of TransCelerate BioPharma, which was formed in 2012 with a commitment to engaging and sharing outcomes in order to increase quality and improve upon patient safety, the SIP comes in response to the expressed need for greater collaboration and efficiency.

To date, clinical trial sponsors and research sites have used a variety of documents, websites, and portals requiring separate login accounts in order to perform various responsibilities. In some cases, Kent added, an investigator conducting a study with multiple companies could be juggling over 50 different logins and IDs in order to carry out work across these companies.

With this pain point in mind, the SIP Initiative provides a central system accessed with just one user account login and password. “This will be the first platform in the industry that has a single sign-on no matter who you’re working for,” Kent said.

Exostar is the vendor company that was tapped to address the related authentication issues. As the Identity and Access Management (IAM) solution provider, the company issues and verifies credentials for the individuals who work at organizations using the TransCelerate SIP, according to Tom Johnson, senior director of life sciences solutions at Exostar. It allows organizations to participate in the SIP without putting their sensitive information and intellectual property at risk.

Exostar’s solution relies on the SAFE-BioPharma standard for authenticating identity to participating computer systems and for applying legally-binding and regulatory-complaint digital signatures, explained Mollie Shields-Uehling, president and CEO of SAFE-BioPharma Association.

“It is a very rigorous and robust form of a digital identity that is uniquely and algorithmically linked to its signature,” she said. This standardizing identity assurance is needed to comply with a wide array of laws and regulations that protect intellectual property, personal health data, and other confidential information, Shields-Uehling added, and ultimately it provides the identity trust needed for the SIP and all of its participants to be able to collaborate efficiently and securely.

Another key source of concern that the SIP tackles is redundancy. When a clinical study is carried out, Kent explained, questions are asked and information is compiled about the clinical investigator and the hospital or clinic at which they work.

“We ask the same questions over and over again, so we created what we’re calling the Investigator Registry (IR) Initiative, and that registry has people information and facility registration,” Kent said. DrugDev Data Solutions was selected as the partner to provide the platform needed to store that shared repository of details.

According to Elisa Cascade, president of DrugDev, the IR links together profiles from the SIP with TransCelerate member companies’ clinical trial management systems, the DrugDev investigator network, public data, and other third party sources using the DrugDev Golden Number—a universal identifier. The goal is to provide an evidence-driven approach for accelerating the identification and recruitment of qualified investigators.

Bringing sites and sponsors together on a common platform will ultimately simplify processes and reduce the amount of time spent on standard study activities, according to Kent. Whereas various training and document management activities were performed over and over again in differing ways across different member companies, they’ll now be conducted once and that information will be shared. The result is a clearer, simpler communication method for the sites.

Hurdles Overcome

Achieving this type of simplified communication comes about as a result of highly complex collaborative processes. Bringing together so many different member companies and vendors presents plenty of logistical challenges, Kent explained. From an IT perspective, there has been an ongoing need to navigate the various architectural challenges presented by the project, for example.

“We want to create an open platform that allows member companies to choose how and when they adopt,” she said. “Coming up with a framework for everyone to have the most opportunity has been very challenging, but it’s also been very eye-opening. I think it’s actually brought together a lot of unique ideas on how to go about the design of the application to create possibilities.”

The relationship between the vendor partners and the member companies is unique, Kent explained, and while the software development lifecycle has been an enjoyable dilemma to work through, the contractual piece of it has been complicated. Ultimately, the system integrator—Cognizant—has managed all of the contracts and passed costs to the member companies.

“We really do want an open architecture where we’re allowing multiple vendors to play in this space to continue to allow the application to have the best of the best within it, but it’s a bit of a challenge to work on all of those different relationships,” she added. “The daily negotiation of managing the process is more complex than we ever thought it would be.”

Looking Ahead

Eli Lilly is the first TransCelerate member company to adopt the SIP and is actively implementing its first study; an additional six member companies are preparing to begin implementation as well.

“I’ve been involved with clinical research sites in my day job as well as my TransCelerate work for quite a few years now, and I think it’s just really exciting to see us all working together with hopes of taking the burden off the sites,” Kent said. “For them to be moving paper differently across our organizations is frustrating when what we really want is to allow these really talented physicians more time to treat their patients.”

Over the course of the next several years, added features and capabilities will continue to be released. Document management and workflow safety mailing processes are already underway, noted Kent, and electronic signatures, payments and clinical supply reordering are all priorities that will be addressed moving forward.