The Silicon Review

August 2018 | Read the full article here

As the pharmaceutical industry keeps making advancements, life sciences companies must find new ways to develop and test new drugs as quickly and efficiently as possible. For a long time, these companies have depended on paper-based processes for clinical trial data capture. These inefficient methods place significant burden on clinical research sites and increase the time and cost of drug development. However, many clinical research sites could not afford costly electronic source (eSource) solutions, until now.

Founded in 2009, Alpha Clinical Systems is dedicated to modernizing and streamlining clinical trials by delivering the world’s most flexible and affordable eSource solution. Purpose-built to minimize clinical trial burden and complexity, the ACS360 platform captures clinical trial data directly via tablet. Unlike first-generation eSource solutions which were sold only to Big Pharma and CROs, ACS360 was designed for use and purchase by clinical research sites, CROs, biotechnology and pharmaceutical companies.

The beginning of a new idea

Nearly four years after ACS was founded, the Food and Drug Administration (FDA) released its final guidance on Electronic Source Data in Clinical Investigations. Developed as part of an effort by the FDA to streamline and modernize clinical investigations, the September 2013 eSource guidance promoted the capture of clinical trial source data in electronic form—as opposed to traditional, paper-based electronic data capture (EDC). At this time, ACS leadership saw an opportunity to develop a purpose-built systems for capturing clinical trial data via tablet or laptop. Unlike popular EDC systems, where clinical trial data was initially captured on paper, ACS would develop a platform for capturing clinical trial data directly in electronic format. This new eSource system was specifically designed to eliminate the root cause of slow, expensive clinical trials—paper-based data capture.

Simplifying data capture

Unlike some eSource solutions, ACS provides all the benefits of FDA endorsed eSource data capture while eliminating the key challenges slowing adoption among life sciences companies. An August 2016 survey of member pharmaceutical companies by the non-profit organization, TransCelerate BioPharma, found that the key challenges preventing more widespread eSource adoption include:

1) site training/infrastructure
2) expense of eSource software/platforms
3) time consuming study starts
4) provisioned device logistics

The ACS360 platform is positioned as the world’s most affordable, flexible and comprehensive eSource solution. Designed to be exceptionally user-friendly, ACS360 requires minimal site training and infrastructure, operating with or without an internet connection. Requiring no technical expertise, users can build their own eSource studies that are ready for use in 2-4 weeks. The ACS360 platform works on any iOS or Android device.

ACS360: Integrated and customizable cloud-based eSource platform

Alpha Clinical Systems’ flagship product, ACS360, is a fully-integrated, cloud based eSource platform that eliminates slow, error-prone paper-based data capture. ACS360 features user-friendly design that dramatically reduces burden on site users by streamlining data capture, improving data quality and delivering real-time, remote data access. The ACS360 platform is comprised of Study Designer, es-SourceDocx, Study Monitor, ez-Consent, ez-DIMS, ez-PRO/COA, ez-Scheduler and ez-BudgetManager.

ACS360 was designed to reduce the cost and complexity challenges that prevent more widespread eSource adoption — while offering a full suite of solutions that make clinical trials better, faster and safer for sites, CROs, sponsors and subjects. The ACS360 platform can also be integrated with any third-party EDC to deliver direct eSource data capture. While many first-generation eSource solutions were designed to completely replace legacy EDC systems, ACS360 works with or without existing EDC systems.

Transforming clinical trials

ACS has seen the greatest customer traction among sites and small to mid-size pharma and CROs because there are few eSource solutions that are affordable, comprehensive and flexible. Most eSource solutions are sold directly to large sponsors who purchase the eSource solution that sites would use. However, as more sites become aware of the efficiency benefits made possible by eSource, the demand for this technology has grown. Cutting-edge sites purchase solutions like ACS360 to improve efficiency in terms of better, faster data capture. More robust, fully-integrated solutions like ACS360 help sites improve efficiency and accuracy of data capture, budgeting and financing, recruiting and scheduling subjects, and drug inventory management, just to name a few.