Murthy Gandham, CEOFor several years, the pharma and life-sciences industry has been tackling mounting concerns to effectively modernize and streamline the way sponsors and other stakeholders collect data in clinical trials. A survey conducted in 2016 by TransCelerate, a non-profit organization, revealed some of the key challenges that continue to prevent more widespread adoption of electronic source (eSource) data capture. TransCelerate confirmed that there is huge demand for a cloud-based technology that captures and validates data electronically at the source.
The U.S. FDA and EMA have both endorsed and supported eSource data capture for clinical investigations to help sponsors achieve more conclusive clinical trials and operational efficiency. Nevertheless, few key obstacles hinder eSource adoption, including site training or infrastructure and cost associated with provisioned devices; the expense of eSource platform; and time-consuming study starts. Founded in 2009 as an eSource company, Alpha Clinical Systems’ value proposition lies in delivering next-generation eSource that minimizes adoption challenges to help life sciences companies bring drug therapies to market faster and with less cost through paperless clinical trials.
“Our next generation eSource framework—ACS360 helps pharma and life-sciences companies move towards truly paperless clinical trial data capture and dramatically reduce study time, cost and risk,” says Murthy Gandham, CEO, Alpha Clinical Systems (ACS). The firm’s flagship product is ACS360, a fully-integrated, cloud-based and affordable eSource platform, which offers a full suite of paperless data capture solutions that reduce burden for Site users, sponsors, and other stakeholders. ACS360 also helps users eliminate double data entry and source data verification—by validating data immediately upon entry—to deliver quality data in real-time for remote monitoring.
Sending armies of site monitors out to conduct 100 percent source data verification at every investigative site is not the solution for ensuring data quality, nor is it an efficient use of resources. ACS360 provides integrated Tablet/Cloud-based framework for on-line/off-line eSource/ eCRF data capture with completion guidelines, intelligent data synchronization, remote monitoring, smart query resolution, allowing monitors and sponsors to view data in real-time across the clinical trials continuum.
Our value proposition is to deliver next-generation eSource solutions to customers and help them bring better drug therapies to market through smarter clinical trials
Unlike first-generation eSource platforms, ACS360 can be integrated with any third-party EDC to directly capture eSource data during subject visits, ensuring accuracy and completeness of data for researchers with any level of experience. With more than two decades of software development experience, ACS delivers innovative and custom software solutions that aid clinical trial professionals to meet study needs more effectively. The key strategy that has helped Alpha Clinical Systems to stay ahead of the competition is their knowledge about the current market requisites and their capability to deliver a best-in-class solution that accelerates and enhances the research and development of innovative new therapies. “Our strengths include listening to customer needs and bringing innovative and flexible software products to the market to meet or exceed our customers expectations,” prides Gandham. The firm closely monitors industry feedback of first-generation eSource solutions to ensure its eSource solutions are affordable, comprehensive, and flexible to serve a global user base.
As a next-generation eSource solution, ACS360 is designed for direct purchase and use by cutting-edge sites that seek to realize significant time and cost savings. “By leveraging ACS360, these sites can improve efficiency in terms of better, faster data capture and seamless budgeting and financing and electronic drug inventory management,” elucidates Gandham. ACS has recently integrated various add-on features such as ez-Budget Manager; ez- Scheduler (Site Recruitment), ez-PRO (Patient Reported Outcome) and ez- Consent (electronic informed consent) into its ACS360 platform, enabling site users to dramatically reduce both time and cost. Leveraging these exclusive features, users can significantly eliminate slow and error-prone manual processes in clinical trials and focus on more value-added activities.