“Modernizing and streamlining clinical trials by delivering custom software solutions “
Murthy Gandham, President Alpha Clinical Systems: With an economical eSource platform, clinical trial efficiency, quality, and safety can all be improved.
Life sciences businesses must find innovative techniques to create and test new treatments as rapidly and efficiently as possible as the pharmaceutical industry advances. For a long time, these businesses relied on paper-based systems to collect clinical trial data. These inefficient procedures increase the time and cost of drug development by putting a huge strain on clinical research locations. Until today, however, many clinical research facilities were unable to afford expensive electronic source (eSource) solutions.
Alpha Clinical Systems, founded in 2009, is committed to modernising and expediting clinical trials by providing the world’s most versatile and cost-effective eSource solution. The ACS360 platform takes clinical trial data directly via tablet, reducing clinical trial burden and complexity. Unlike previous eSource systems, which were solely sold to Big Pharma and CROs, ACS360 was created for clinical research sites, CROs, and Big Pharma to use and acquire.
The beginning of a new idea
The Food and Drug Administration (FDA) presented its final advice on Electronic Source Data in Clinical Investigations about four years after ACS was created. The FDA’s September 2013 eSource advice, which was developed as part of an effort to streamline and modernise clinical investigations, encouraged the electronic capture of clinical trial source data rather than traditional, paper-based electronic data gathering (EDC). ACS leadership saw an opportunity to create a custom system for obtaining clinical trial data by tablet or laptop at this time. ACS would provide a platform for capturing clinical trial data in electronic format, unlike popular EDC systems, which initially gathered clinical trial data on paper. This new eSource solution was created to address the core reason of sluggish, costly clinical trials: paper-based data gathering.
Simplifying data capture
ACS, unlike some other eSource solutions, provides all of the benefits of FDA-approved eSource data capture while removing the major barriers to adoption among Life Sciences organisations. The key challenges preventing more widespread eSource adoption, according to a survey of member pharmaceutical companies conducted by the non-profit organisation TransCelerateBioPharma in August 2016, are: 1) site training/infrastructure; 2) expense of eSource software/platforms; 3) time-consuming study starts; and 4) provisioned device logistics.
The ACS360 platform is marketed as the most cost-effective, adaptable, and complete eSource solution in the world. ACS360 is a user-friendly system that requires minimum site training and infrastructure and may work with or without an internet connection. Users can create their own eSource studies with little technological knowledge and have them ready to use in 4-6 weeks. Because the ACS360 platform operates on any iOS or Android device, supplied device logistics are no longer necessary.
ACS360: Integrated and customizable cloud-based eSource platform
ACS360, the flagship product of Alpha Clinical Systems, is a fully integrated, cloud-based eSource platform that replaces inefficient, error-prone paper-based data capture. ACS360 is a user-friendly architecture that streamlines data capture, improves data quality, and provides real-time, remote data access, reducing the burden on site users significantly. Study Designer, ez-SourceDocx, Study Monitor, ez-Consent, ez-DIMS, ez-PRO/COA, ez-Scheduler, and ez-BudgetManager are all part of the ACS360 platform.
ACS360 was created to address the cost and complexity barriers that now hinder more broad eSource usage, while also providing a comprehensive set of solutions that improve the quality, speed, and safety of clinical trials for sites, CROs, sponsors, and subjects. Any third-party EDC can be coupled with the ACS360 platform to provide direct eSource data gathering. ACS360 works with or without existing EDC systems, unlike many first-generation eSource solutions that were designed to totally replace legacy EDC systems.
Transforming clinical trials
Because there are few eSource solutions that are economical, comprehensive, and adaptable, ACS has seen the most customer traction among sites and small to mid-size pharma and CROs. The majority of eSource solutions are sold directly to corporate sponsors who buy the eSource solution that will be used by the sites. However, as more businesses become aware of the cost-cutting benefits of eSource, demand for the technology has increased. Cutting-edge locations invest in technologies like ACS360 to boost efficiency by capturing data more accurately and quickly. Data capture, budgeting and funding, recruiting and scheduling subjects, and medicine inventory management, to mention a few, all benefit from more comprehensive, fully integrated solutions like ACS360.
Knowing the man behind Alpha Clinical Systems
Murthy Gandham, CEO
Murthy Gandham, the company’s founder and CEO, is in charge of providing effective leadership, strategy, direction, and control of all business/product development and corporate activities. In 2009, Murthy created Alpha Clinical Systems with the goal of developing a next-generation eSource platform that would make eSource data capture more inexpensive and accessible to the life sciences industry, particularly research sites and small to mid-size pharma, biotech, and CROs.
From strategy and concept to implementation and deployment, Murthy oversees product development for the company’s flagship product, ACS360 (September 2016). Murthy put together a high-performing worldwide team to continue developing the ACS360 platform into a world-class, cloud-based integrated clinical data management suite of solutions, which includes eSource, ez-PRO/eCOA, and the ez-Consentand electronic medication inventory management system. Murthy spent the previous 20 years in a variety of leadership roles, developing software products for firms in the Insurance, Financial Services, and Pharmaceutical industries. He graduated from the Indian Institute of Technology in Kharagpur with a master’s degree in mechanical engineering.