Nick Slack, President
Despite technological advancements in the clinical trial landscape, most biopharmaceutical companies still struggle to aggregate accurate, real-time information about their clinical trials from different silos. Oceans of data and disparate clinical trial workflow solutions do little to identify and ameliorate points of friction that lead to study delay. To overcome this challenge, biopharmaceutical firms need an efficient platform that can simplify the clinical trial management process and turn these disconnections into powerful connections. Providing an intelligent e-clinical solution to “uncomplicate” the chaos of clinical trial management is ePharmaSolutions (ePS). Leveraging their vast experience in the management of clinical trials, ePS is dedicated to supporting the drug development industry–both large pharmas and emerging biotechs—with the groundbreaking ePharmaONETM platform that delivers technology-enabled solutions that empower sponsors, contract research organizations (CROs), and investigative sites to streamline and accelerate clinical trials by helping them to optimize study workflow and communication, providing increased visibility into study performance metrics.
“Our focus is all about solving major causes of study delays by using technology, people, and processes,” states Nick Slack, president of ePS. In many instances, clinical trials experience substantial study delays due to slow enrollment, poor data quality, lack of test article controls, and weak project team communications. “The first and foremost decision that pharmaceutical companies need to make during clinical trials is choosing investigators who are most likely to enroll subjects into a study,” says Slack. To achieve that, ePS banks on their treasure-trove of predictive and actionable investigator information—and helps sponsors to choose the right investigators for their study.
Through surveys and ranking responses from sites, the ePharmaONE platform enables clinical research sponsors and CROs to optimize the process of identifying qualified sites to conduct a study. By providing an online learning management system, the firm allows biopharmaceutical companies to effectively train their study teams for clinical trials anywhere, anytime. Embedded with an electronic trial master file (eTMF) application, ePS’s ePharmaONE platform helps study teams to manage all essential documents with automated review and quality check processes to ensure inspection readiness.
In addition, ePS’s e-clinical solutions also provide secure document exchange capability, enabling sites to negotiate, finalize, and digitally sign all study-specific, contractual, and regulatory documents. The firm has further automated the distribution of safety letters in real time with the click of a button. Sensitive documents like SUSARs and investigator brochures (IB) are transferred securely to investigative sites, which help biopharmaceutical companies to comply with reporting regulations, while reducing the time, expense and burden of doing so using traditional methods.
ePS has helped numerous biopharmaceutical partners with the distribution of safety information across 200 countries. Slack cites a scenario in which a client manually generated individual safety letters and utilized FedEx to distribute documents all around the world. They were in need of a solution that could bring transparency and visibility into the clinical operational processes. ePS’s ePharmaONE platform enabled them to better connect trials, standardize processes, and automate workflows. The client could also successfully automate the distribution and tracking of safety documents, and support sites in maintaining compliance through the use of reminder notifications.
With solutions tailored to support the unique needs of both large pharmaceutical companies, and emerging biotechs with limited resources, ePS is poised to help clinical research sponsors reduce the time, money and effort required to bring new therapies to market.