Bioforum, a data-focused, technology-driven CRO, today announced the acquisition of Validify (Applato Systems Ltd.), a leader in the automation of computer systems validation (CSV). With this expansion, Bioforum is addressing the growing demand for proven technology solutions to digitize and automate CSV, a traditionally manual, paper-based, process that can be prone to errors and compliance risks and costly and time-consuming for life sciences organizations to implement.
Validify provides a proven, agile, cloud-based platform that is fully configurable and rapidly deployable, enabling clinical trial sponsors to digitize their validation process, implement a risk-based computer software assurance (CSA) approach, and eliminate the burdens of the traditional CSV process with a comprehensive automation solution. Pharmaceutical, biotech, medical device, and other life sciences organizations leverage Validify to reduce validation risks and improve regulatory compliance, accelerate project timelines, enhance traceability and audit readiness, avoid over-testing and shorten cycle times, and enable collaboration.
“CSV is a complex process in clinical trials, particularly because the manual testing of software requires a tremendous amount of time and resources and is monotonous work that can lead to errors and compliance risks. Consequently, these challenges often result in a reluctance to embrace innovative new technologies and delays in deploying new versions of software,” said Amir Malka, Bioforum’s CEO and co-founder. “Today, however, by adopting a risk-based approach and the right tools, life sciences organizations can determine the appropriate level of testing and documentation required to meet regulatory expectations, while leveraging advanced technology to automate validation processes, curb costs, and increase efficiency and speed.”
Malka added: “Our acquisition of Validify represents a natural next step and an exciting growth opportunity for Bioforum, and we’re proud to welcome a team that shares our commitment to delivering solutions that move clinical trials forward and accelerate the delivery of new treatments to patients.”
The addition of Validify deepens Bioforum’s clinical trial data management capabilities and complements its growing suite of cloud-based automation solutions, including BioGRID, which provides visual analytics for data-driven insights, and JetConvert, a first-of-its-kind tool that provides unparalleled speed in SDTM conversion.
Ido Raz, CEO and co-founder of Validify, and the architect of its platform, will join Bioforum and continue to lead the development and commercialization of the SaaS solution:
“I’m thrilled to join Bioforum and look forward to working with the highly experienced team there to deliver a solution that removes friction in the CSV process and proactively supports a continuous approach that meets stringent validation requirements while contributing to the acceleration of drug development.”