Mumbai, October 03rd, 2025: Parexel, a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry today 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 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.”
Parexel has already leveraged Weave’s flagship offering, AutoIND, to support Investigational New Drug (IND) applications, and has been able to complete them 50% faster than traditional IND authoring timelines. These scalable efficiency gains enable high quality INDs to be developed at a transformative pace, supporting sponsors with the time-sensitive step of initiating new clinical trials sooner than current industry timelines. Weave’s AutoIND functionality is now part of Weave’s comprehensive regulatory workflow solution, The Weave Platform, that spans the entire regulatory lifecycle.
“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.