Best Practices Winner: Genentech
Project: Clinical Trial Portal
Category: Clinical Trial Management
Nominated by: ePharmaSolutions
By Deb Borfitz
July 20, 2009 | When it comes to streamlining and systematizing the clinical research process, it’s unlikely that any company is doing more than biotechnology founder Genentech. Its relationship with investigative sites is being wholly managed through a single-sign-on Clinical Trial Portal (CTP). Pilot- and production-level rollout is resulting in quicker study start-ups, improved enrollment rates, and significant cost savings (around $10,000 per site).
Commenting on the CTP, a Genentech executive who was not directly involved in the project said, “Alyssa [Ventura, head of clinical information systems management at Genentech]… and her small team jumped through untold fires to make it happen. It is a well deserved victory.”
CTP is “a portal facilitating drug development and research—automating all the regulatory documentation, drug safety reporting, adverse event reporting for clinical trials,” explained Jennifer Reichuber, senior manager, Clinical Information Systems Management, Genentech, when accepting the award.
The features of CTP cover the full gamut of activities in which clinical trial stakeholders are collaboratively engaged. From the perspective of sites, the enchanting feature of the CTP is that it provides a single point of interaction with Genentech for all studies conducted on the sponsor’s behalf, says Lisa La Luna, senior VP corporate development and implementation for nominating organization ePharmaSolutions, which eight years ago developed the portal for clinical trials. The fact that sites can always log on to Genentech trial management technologies with the same user name and password significantly reduces the “burden” on study sites.
Market research conducted by ePharmaSolutions in 2008 found that sites were struggling to recall an average of seven to ten—and sometimes as many as 15—user names and passwords associated with technologies required by multiple sponsors, says La Luna.
For project managers at Genentech, CTP makes it easier to improve site selection and activation through a proprietary application that ranks sites according to their ability to succeed in each study; completes the regulatory document and contracting process with digital signatures; and delivers and tracks safety letters (SUSARS), study training, and online investigators’ meetings, says La Luna. It also shields studies from informational black holes created by a departing study coordinator or a change in clinical research organization (CRO).
CTP is being integrated with Genentech’s interactive voice response, electronic data capture, and clinical trial management system. All user activity is time stamped and tracked for regulatory purposes. Conducting site feasibility, study documents, and study training through a Corporate Portal in a “parallel process” generally expedites study start-up by up to 30-40%, says La Luna. As a standard service, the Corporate Portal helps “enforce” timelines by sending sites electronic and telephonic reminders to submit/edit study documents, read SUSARs, and complete training.
A patient recruitment hub gives sites access to institutional review board-approved recruitment material and a recruitment referral tracking system detailing the referral source, cost per referred patient, and whether or not the patient was ultimately enrolled into the study.
La Luna points out that ePharmaSolution has built and hosted a Corporate Portal for a dozen study sponsors, but Genentech is the only firm to embrace the entire suite of available features and integrate the solution with its existing trial management technologies.
“We really appreciate all the work EPS has put into the project for us,” said Reichuber. “[This has been an] excellent collaboration with EPS.”
ePharmaSolutions credits the Corporate Portal with an estimated 25% improvement in study launch times, a 15% reduction in tasks associated with overall trial management times, a 50% reduction in travel requirements for investigator meetings, and an 80% reduction in paper documentation. Cost savings estimates were calculated at $50 million when compared to traditional CRO rates annualized across 75 studies utilizing 75 sites each. La Luna says feedback about CTP has been collected from more than 2000 sites over the past two years. The study portal process received a 94% approval rating among sites participating in the 2008 survey.
It appears that Genentech has met all of its primary objectives for the project as described by Ventura: To “introduce a means for adding speed and efficiencies to our clinical trial execution process, in an eco-friendly environment, and enhance the clinical trial sites experience in working with Genentech.”
This article also appeared in the July-August 2009 issue of Bio-IT World Magazine.
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