Pharma Focus Asia

Bioforum Enhances Clinical Trial Technology and Services With Validify Acquisition

Tuesday, November 21, 2023

Bioforum, a data-focused, technology-driven Contract Research Organization (CRO), has recently completed the acquisition of Validify (Applato Systems Ltd.), a leading player in computer systems validation (CSV) automation. This strategic move by Bioforum is aimed at meeting the increasing demand for technology solutions to digitize and automate CSV processes within life sciences organizations. Traditionally, CSV has been a manual, paper-based procedure susceptible to errors, compliance risks, and significant time and cost investments.

Validify brings a proven, agile, and cloud-based platform that is fully configurable and quickly deployable. This platform allows clinical trial sponsors in pharmaceuticals, biotech, medical devices, and other life sciences sectors to digitize their validation processes. By implementing a risk-based computer software assurance (CSA) approach, Validify's solution eliminates the challenges associated with traditional CSV, providing a comprehensive automation solution. Benefits include reduced validation risks, improved regulatory compliance, accelerated project timelines, enhanced traceability and audit readiness, avoidance of over-testing, shortened cycle times, and improved collaboration.

Bioforum, emphasized the complexities of the CSV process in clinical trials, highlighting the time and resource-intensive nature of manual software testing. Malka expressed optimism about the potential for life sciences organizations to overcome these challenges by adopting a risk-based approach and leveraging advanced technology to automate validation processes. The acquisition of Validify aligns with Bioforum's commitment to delivering innovative solutions that advance clinical trials and expedite the development of new treatments.

The addition of Validify enhances Bioforum's capabilities in clinical trial data management and complements its suite of cloud-based automation solutions, which includes BioGRID for visual analytics and JetConvert, a tool known for its speed in SDTM conversion. Ido Raz, CEO, and co-founder of Validify will join Bioforum to lead the development and commercialization of the Software as a Service (SaaS) solution. Raz expressed enthusiasm about contributing to the acceleration of drug development by delivering a solution that streamlines the CSV process and supports a continuous approach aligned with stringent validation requirements.




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