Medrio, a provider of eClinical technology for pharma, medical device, and diagnostic companies conducting clinical trials, and Bioforum, a data-focused contract research organization (CRO) offering end-to-end services to life sciences companies worldwide, have announced a partnership to optimize the clinical data standardization process. The collaboration will provide Medrio clients with access to JET-Convert, Bioforum’s solution for standardizing clinical data in a regulatory compliant, submission-ready format, furthering efforts to accelerate clinical trial timelines while improving patient safety and outcomes.
Leveraging artificial intelligence (AI) technology, Bioforum’s solution automates clinical data standardization using a submission-ready format that follows Clinical Data Interchange Standards Consortium (CDISC) guidelines. Required by the FDA, CDISC standards address the need to better structure and improve the quality and consistency of research data, allowing for the meaningful exchange of information between all clinical trial stakeholders, including clinicians, researchers, pharmaceutical companies and regulatory authorities.
“Reducing variation and standardizing clinical data is central to improving its quality and usability,” said Mike Novotny, Founder and Chief Executive Officer of Medrio. “We’re thrilled to partner with Bioforum and provide our clients with access to its pioneering JET-Convert solution, a powerful tool that will enable better data integration and reusability, the facilitation of data exchange with partners as well as regulatory reviews and audits, and, ultimately, speed up efforts to bring innovative medical treatments to patients around the world.”
Bioforum’s Co-Founder and President Amir Malka added, “Our partnership with Medrio addresses the industry’s urgent need for a solution that can standardize clinical data at scale. We’re excited to launch this collaboration and confident that together we can help our life sciences clients improve efficiencies in all stages of clinical development-from study design and start-up through execution and submission.”
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.