Aug 15, 2005 | Driven by the rush to keep product pipelines full while moving target compounds efficiently and safely through clinical trials, the outsourcing of clinical research processes is rapidly becoming a mission-critical component of corporate strategy at many biopharmaceutical companies. Given the choice, many of these organizations are opting to leverage a clinical research process outsourcer that has access to the requisite technology rather than make the up-front investment themselves. A fundamental factor in this decision is gaining access to technology that enables speed and efficiency of clinical research processes.
Recent research by Life Science Insights* indicates that biopharmaceutical companies are flocking to consultants, outsourcers, and staffing firms to help with technology selection, trial process redesign, data management, and biostatistics, among other discrete clinical trial processes, to gain access to advanced technologies and reduce the drain on already-scarce IT resources. Further, clinical operations executives are finding themselves under pressure to contribute to cost reduction and are increasingly looking to automate activities to keep costs in line and to create more value for the corporation. Outsourcing of clinical trial processes helps clinical operations maintain a lean organization and free up clinical staff to become more consultative in adding the development and execution of business goals and strategies.
In addition to helping address the company’s business issues, clinical operations executives are also heeding the call to action from the FDA. In its March 2004 guidance, “Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,” the FDA stated that access to technology is a strategic imperative for the industry. “There is...an urgent need to improve the efficiency and effectiveness of the clinical trial process, including trial designs, endpoints, and analyses,” said the guidance. The FDA also identified a number of technologies as a key input to process improvements.
We agree with the FDA that this is indeed a critical time for biopharmaceutical companies to revise their strategies around clinical trials and to address the opportunities afforded by outsourcing various clinical trial activities. Clinical operations executives have an opportunity to improve cost and performance metrics by addressing some or all of the following components of their clinical trial processes:
• Assess clinical trial management systems and electronic data capture (EDC) to speed up trial management.
• Optimize site and investigator networks used for trials.
• Use content management to facilitate electronic regulatory submissions, which can lead to expedited FDA review and internal response to FDA inquiries.
• Add quality-control measures to enhance compliance with good clinical practice.
• Improve the supply chain to prevent delays related to clinical trial supply availability at sites.
• Track, measure, and report efficiency of operations.
• Choose outsourcers and other service providers based on their technology expertise and access to solutions that fit an organization’s needs.
Technology-Integrated Services
Given the recent focus on the use of technology to improve processes and reduce costs for clinical operations, outsourcers and other clinical service providers are seizing the opportunity to differentiate themselves from their competition through their technological expertise and access to the latest technologies.
The coming 18 months will see significant change in the capabilities of these service providers as they invest in updating their infrastructures and in leveraging innovative technologies for clinical trials. Some of these organizations are already offering pre-integrated solutions to support EDC and/or electronic clinical data management (eCDM) technology. Examples include Axio Research, Cato Research, Octagon Research Solutions, Omnicare, Parexel, PRA International, Promedica International, Quintiles, SCIREX, and United BioSource Corporation, among others.
Regardless of their technology capabilities, clinical service providers must focus on quality and expert service. Service providers who offer technology expertise that enables clinical operations executives to achieve faster and more cost-effective trial management will become preferred providers in the near term.
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* Clinical Outsourcing Sponsors Forcing Market Change, LSI #1013, June 2005, and a forthcoming report on CRO-EDC alliances.
Ellen H. Julian is a research director with Life Science Insights. E-mail: ejulian@lifescience-insights.com