By Deb Borfitz
September 13, 2012 | EDC purist Isis Pharmaceuticals is stepping up its partnering activity with BioClinica, Inc. to include larger and more complex clinical trials within its expansive antisense drug development program. Up to 20 new trials are on the docket for next year, including several phase III studies involving thousands of participants.
BioClinica in recent years nudged out four other electronic data capture vendors to become the exclusive technology partner of the Carlsbad, CA-based research company, a global leader in gene-based drug development. Last fall, the relationship was “amended… to be more mutually beneficial and cooperative,” says Kevin Nichols, director of drug development information systems at Isis Pharmaceuticals. BioClinica’s Express EDC solution “does what we want it to do. BioClinica, as a company, is willing to listen to what we have to say about the software and…incorporate [suggested adjustments] to make it more user-friendly.”
As a “power user” of Express EDC, Nichols pushes the software to its limits and expects improvements, interjects Peter Benton, president of BioClinica’s eClinical Solutions. “We love that.” A handful of BioClinica programmers and in-house data management experts attended a two-day conference at Isis Pharmaceuticals in December 2011 to painstakingly deliberate over needed process and software enhancements, including the initial development of form and programming libraries.
Impressively, BioClinica has yet to charge a single change order fee despite many months of testing and tweaking of its Express EDC solution to suit study needs, Nichols adds. “That’s extremely unusual and one of the reasons we switched [to BioClinica].” Routine changes to study protocols, and thus data capture forms, can add up to “hundreds of thousands of dollars” over the course of all of Isis’ current and future studies. By eliminating these charges, Nichols figures BioClinica has effectively shaved between 10% and 15% off the EDC portion of his company’s clinical trial budgets.
The extra fees charged by most vendors for relatively minor modifications to form fields and functionality have mushroomed EDC budgets by as much as 30% at some companies, adds Benton.
In addition to the competitive cost structure of Express EDC, Nichols cites “ease of use” as another reason Isis Pharmaceuticals embraced the software as its EDC of choice. “It creates well-organized workflows based on the data that is entered at doctor sites,” he notes, in addition to being easily customizable even after the study starts. BioClinica also “seems to be far more interested in customer satisfaction and retention [than other eClinical providers].”
Since late 2009, BioClinica has worked on almost 30 studies for Isis Pharmaceuticals that have helped build an electronic library of reusable forms, edit check libraries, and database programming to streamline subsequent study startups, says Nichols. Isis Pharmaceuticals currently has 25 antisense drugs in its pipeline applicable to an assortment of genetic disorders and infections.
Historically, Isis has financed early-phase antisense drug development and then partnered with other pharmaceutical and biotechnology companies that bring the resulting products to market. Its first success story was the anti-viral AIDS drug Vitravene, marketed by Novartis. Genzyme has more recently taken over late-stage development of the lipid-lowering drug Kynamro formulated by Isis scientists. It has 11 such partnerships in all.
At BioClinica’s three-day user conference in October, Express EDC devotees will have a chance to learn more about how Isis Pharmaceuticals uses the software to create data table and edit check libraries using standard clinical trial data. The libraries are used when developing databases to ensure consistency across studies, reducing database development and testing time.