ePharmaLearning Inc. ePharmaLearning Inc., Conshohocken, Pa., is an industry leading site qualification, clinical e-learning, and site activation company. For more information, visit epharmalearning.com. The keys to improving a clinical trial’s operational success include selecting the best sites for the study, ensuring those sites clearly understand the protocol and study procedures, and making sure the sites are activated efficiently. By focusing on these three fundamental building blocks of study launch, pharmaceutical companies and CROs can improve site performance and quality while reducing cycle times and cost. Better Site Profiling and Qualification Selecting the best sites for a study begins with ensuring that they have the right patients and wear-with-all to be successful for the trial. Although there are no guarantees that patient population profiling will result in an overenrolled study, companies could improve the odds substantially by using de-identified data that are readily available from a company’s marketing department. The use of de-identified decision support data, such as insurance claims and prescriptions, to estimate a site’s patient population has increased in popularity during the last few years. Combining clinical experience data (1572s), claims data (ICD-9s), and prescription data from NDC or IMS with a study-specific screening process conducted by a trained enrollment specialist will result in improved enrollment rates in most cases. Adult-Learning Enriched Study Training Improving the protocol and study procedure training process could arguably yield the best return from a cost-saving and site-performance perspective. In most cases today, major pharmaceutical companies pay more than $350,000 for in-person investigators’ meetings involving 75 sites without any verification that the sites understand the protocol or study procedures. In an effort to reduce costs, many pharmaceutical companies are turning to Webcasts in lieu of the expensive in-person meetings. This can be a dangerous proposition if the right processes and tools are not in place. In today’s technology-driven clinical-trials environment, sites must be provided with effective live and on-demand online training that incorporates adult-learning theory with interactive exercises and assessments to certify completion and verify content comprehension. A well-designed online protocol and study procedure training program will result in a 60% improvement in protocol comprehension and a 40% to 50% improvement in site quality, while offering a more than 70% cost savings compared with traditional in-person investigator meetings. Technology and Communication The increase of technology-enhanced clinical trials, in addition to the complexity of protocols and study procedures, is straining already overworked investigators and study coordinators, who are ultimately clients of the pharmaceutical industry. Using portal technology to provide sites with a single online place to go for all of their study needs certainly helps accelerate and improve the study launch process for sponsors, while streamlining and systematizing the study launch for site staff. Portals allow sites to access one secure workspace to complete feasibility surveys, online study documents, online protocol/procedure training, and link to clinical-trial applications, such as EDC and trial-management technologies. The system also time-stamps and tracks all user and training activity for study and site progress reporting. If pharmaceutical companies improve the three important areas associated with site activation — profiling and qualification, adult-learning study training, and technology and communication — they can reduce clinical cycle times, increase quality, and achieve significant cost savings. For example, converting 100 studies to online site activation can result in cost savings of more than $40 million a year. If pharmaceutical companies improve the three important areas associated with site activation — profiling and qualification, adult-learning study training, and technology and communication — they can reduce clinical cycle times, increase quality, and achieve significant cost savings. June 2005 VIEW on Clinical Services ePharmaLearning Inc., Conshohocken, Pa., is an industry leading site qualification, clinical e-learning, and site activation company. For more information, visit epharmalearning.com. If pharmaceutical companies improve the three important areas associated with site activation — profiling and qualification, adult-learning study training, and technology and communication — they can reduce clinical cycle times, increase quality, and achieve significant cost savings. Lance Converse CEO Site Qualification and Training: Immediate Time, Cost, and Performance Improvements June 2005 VIEW on Clinical Services Site Selection

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