Collaboration leverages Parexel’s proven regulatory expertise and Weave Bio’s AI-native platform, aiming to speed up the market introduction of new therapies
Parexel, a leading global clinical research organization (CRO), announced a partnership with Weave Bio, a pioneer in AI-native regulatory automation management solutions, aimed to accelerate regulatory submission processes and the time to market for new therapies. Under the agreement, Parexel will serve as Weave’s CRO design partner and will leverage Parexel’s extensive regulatory consulting expertise across clinical, non-clinical, clinical pharmacology and chemistry, manufacturing, and controls (CMC) to enhance Weave’s AI platform and product pipeline. In addition, Parexel will maintain a period of exclusivity as the only CRO licensed to use Weave’s innovative solutions after the new products launch.
“This partnership represents a significant advancement in Parexel’s vision to leverage AI to speed clinical research processes, enhance first-time quality and accelerate the delivery of life-changing therapies to patients,” said Paul Bridges, President, Consulting, Parexel. “We’re beginning this partnership by addressing an area where sponsors feel extreme urgency – early regulatory authoring and submission preparation. By combining Weave’s cutting-edge AI technology with the human-in-the-lead expertise of Parexel Consulting, we’re helping teams move faster and with greater confidence while maintaining the highest levels of quality and compliance.”
“AI tools are only as strong as the people behind them. Human experts provide the context that guides our platform and help translate its findings into action,” said Lindsay Mateo, Chief Commercial Officer at Weave. “Through this partnership, Weave will tap into Parexel’s deep regulatory expertise to refine and expand our solutions across the drug development industry.”
Parexel and Weave are presenting at the Regulatory Affairs Professionals Society (RAPS) Convergence on October 7-9 in Pittsburgh, Pennsylvania and will discuss the partnership during presentations and at their booths.
Thought leadership session: Speed Without Shortcuts: Navigating Regulatory Boundaries for AI Applications in Clinical Trials featuring
· Tala Fakhouri, Vice President Consulting, AI & Digital Policy, Real-World Research, Parexel
· Ryan Zettle, Head of Regulatory Submissions, Americas, Regulatory Consulting, Parexel
Sponsored Presentation: Lessons from a comparative analysis of old and new AI-infused regulatory processes
· Brandon Rice, CEO & Co-Founder
