As clinical trials continue to grow in complexity, take longer to initiate, and suffer from patient under-enrollment, more and more clinical research stakeholders are honing in on the advantages offered by the Shared Investigator Platform (SIP), which aims to increase trial efficiencies for sponsors and sites.
Educating attendees of ACRP 2019 in Nashville about the SIP on Friday (April 12) in the annual event’s first-ever lineup of techXpo presentations was Larissa Comis, product lead for the SIP with Cognizant. For attendees who were new to the topic, she explained that the SIP is a clinical operations technology platform created to eliminate duplicative work and harmonize processes to streamline how sponsors choose sites for their studies, and how sites report their capabilities and study results to sponsors.
Sites tied into the SIP fill out a user profile, a facility profile, and an organization profile. “Once these profiles are established, the efficiency gains are tremendous,” Comis said.
One advantage of the profiles is that they allow sponsors to focus on the specifics of their study protocols rather than on designing, collecting, and analyzing endless feasibility surveys intended to help them select sites for studies.
“We’re at a turning point here, which is why I’m so excited about sharing what’s happened with SIP in the last year or two,” said Comis, explaining that the platform has transitioned as planned from being run by TransCelerate BioPharma and available only to its partnering firms, to being overseen by Cognizant and open for free use by any sponsor or site. She said SIP is now active in 79 countries at more than 6,600 facilities with more than 20,000 individual users.
Five major sponsor firms participate in running their protocols through SIP, with a sixth one expected to join by the end of 2019’s second quarter, Comis said. Version 4.0 of the platform should be released in the fourth quarter of the year, with new capabilities added for contract research organization users, she noted.
A representative from SIP user Merck in the techXpo session audience said the platform has helped convince sponsors that they can accept each other’s requirements for Good Clinical Practice training at sites when those sites have not worked with a particular sponsor already. “We believe this will bring immense efficiencies to sites and sponsors,” he said.
Author: Gary Cramer