Bioforum, a data-focused, technology-driven CRO, has just made a big move by acquiring Validify (Applato Systems Ltd.), a leader in the automation of computer systems validation (CSV). This acquisition is a game-changer as it adds computer systems validation automation capabilities to Bioforum’s suite of solutions for clinical trial data management. The expansion comes at a time when there is a growing demand for proven technology solutions to digitize and automate CSV, which has traditionally been a manual, paper-based process prone to errors and compliance risks. This move is set to make life easier for pharmaceutical, biotech, medical device, and other life sciences organizations.
Validify offers a cloud-based platform that is fully configurable and rapidly deployable, allowing clinical trial sponsors to digitize their validation process and implement a risk-based computer software assurance (CSA) approach. This comprehensive automation solution eliminates the burdens of the traditional CSV process, reducing validation risks, improving regulatory compliance, and accelerating project timelines. It also enhances traceability and audit readiness, avoids over-testing, shortens cycle times, and enables collaboration.
Amir Malka, Bioforum’s CEO and co-founder, highlighted the challenges of the manual testing of software in clinical trials, emphasizing the time-consuming and error-prone nature of the process. However, with the adoption of a risk-based approach and the right tools, life sciences organizations can now automate validation processes, reduce costs, and increase efficiency and speed. The acquisition of Validify is a significant growth opportunity for Bioforum, deepening its clinical trial data management capabilities and complementing its suite of cloud-based automation solutions, including BioGRID and JetConvert.
Ido Raz, CEO and co-founder of Validify, expressed his excitement about joining Bioforum and leading the development and commercialization of the SaaS solution. This move is expected to remove friction in the CSV process and proactively support a continuous approach that meets stringent validation requirements while contributing to the acceleration of drug development.
Bioforum, known as ‘The Data Masters’, is a leading global clinical research organization (CRO) specializing in data solutions for the pharmaceutical, biotech, and medical device industries. With a team of experienced professionals and state-of-the-art technology, Bioforum provides a range of services including data management, statistical analysis, and medical writing to help companies bring new drugs and therapies to market faster.
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