Traditionally, the clinical drug research and pharmaceutical industry has been highly siloed when it comes to data. Information is stored within the enterprise and doesn’t leave.
This has been changing in the last few years, though, as drug companies are working with outside researchers, academics, patient groups, government and others to research new medications, says Mollie Shields-Uehling, president and CEO at SAFE-BioPharma Association. “There are all sorts of new players in the clinical trial business,” she explains. “What used to be an inside-the-enterprise operation has become a collaboration among many partners that are far flung around the globe.”
This brought about the creation of the TransCelerate Shared Investigator Platform, a single point of access for interaction between clinical drug research investigators participating in trials from geographically dispersed sites and clinical trial sponsors. TransCelerate is a consortium of 18 clinical trial sponsoring companies that have come together to share resources, establish more uniform processes and streamline the trial process.
Clinical trials used to be paper-based and required scanning, faxing and mailing large amounts of paper because everything required a physical signature, explains Shields-Uehling. The Shared Investigator Platform is designed to make this process electronic to ease collaboration among the different parties involved — without sacrificing the protection of sensitive information or intellectual property – to bring new drugs to market quicker.
The platform is using credentials issued and verified by Exostar that comply with the SAFE-BioPharma digital identity and digital signature standard, says Shields-Uehling. The idea is that with a single credential clinical investigators and other participants will be able to access what they need to collaborate on trials spanning multiple sponsors, as well as apply digital signatures – a requirement for certain regulatory agencies.
Clinical drug research investigators may be working on clinical trials for multiple medications and drug companies. Instead of having to remember passwords and keep separate credentials for each of the companies and trials — as is the case presently — they will be issued a single credential by Exostar that can be used to access the applications and data for any relevant trial, says Vijay Takanti, vice president of security and collaboration solutions at Exostar.
The participating organizations have agreed to a single onboarding process, Takanti says. The new platform aims to reduce the burden on investigators by enabling them to share information with multiple sponsors and make it easy for them to access various sponsor IT systems. For example, if an investigator is working on a trial for a Pfizer medication and then gets hired to work on a trial for Merck, there’s no need to re-execute the onboarding process or issue a new credential.
To start, investigators register through the Shared Investigator Platform. The Platform is integrated with Exostar’s identity and access management solution, which handles identity vetting and credential issuance, in addition to working with existing registries and downstream systems.
Through the Shared Investigator Platform, individuals can access multiple applications, Takanti explains. There are lab notebooks, educational materials about trials, and other applications to promote secure collaboration.
Participants use the Exostar credentials using the SAFE-BioPharma standard to enter and are presented with all the different applications, which they are permitted to access. Exostar is working with the TransCelerate member companies to expand the number of connected applications accessible with the credential, creating a stronger value proposition for trial coordination and delivery.