BioClinica, a provider of clinical trial management tools, is helping Isis Pharmaceuticals and its antisense drug development program bring on more and larger clinical trials, including 16 trials for 2014.
Joan Bailey, manager of clinical data management at Isis Pharmaceuticals, recently presented at a BioClinica conference on the use of BioClinica’s Express EDC software and how it continues to improve Isis’ efficiency.
George Slavish, VP of implementation services at BioClinica, told us: “BioClinica has developed a very close relationship with Isis over the last six years, creating a partnership which is indicative of our typical customer model. BioClinica’s offering is built on a combination of technological innovation and dedicated customer service, to the point where we sent a team of programmers and data management experts to Isis’s offices to collaborate on configuration. It is this combination of process and technology that creates a strong partnership and makes us unique in the industry.”
As far as the system is concerned, Slavish explained that it has many self-service functions including data exports and listings that make it easy for study personnel to get to data quickly. “Express also supports rapid study starts with an extremely efficient study deployment model that allows a study to go from UAT to production in minutes. This study start model allows BioClinica to configure Express to match the sponsor’s database which means less disruption to the sponsor and more time for getting the study up and running,” Slavish said.
The partnership with Isis comes as BioClinica most recently signed two multi-year contract extensions worth $30m for cloud-based technologies and services.
"Our easy change management system also allows customers to experiment with design as part of the study build process, not just after the study has been launched. This allows customers to see different configuration options quickly – often live," Slavish said.
He added that a differentiator for Express is its “ability to make mid-study changes quickly and without additional charges. Express was built by data managers, people who have worked in the industry we understand that change will happen, so the system is designed to make updates immediately so as to limit disruption to the trial and reduce the impact to study budgets.”