Parexel, a leading global clinical research organisation, has announced a partnership with Weave Bio, an AI-native regulatory automation specialist, aimed at speeding up regulatory submission processes and reducing time to market for new therapies. Under the agreement, Parexel will act as Weave’s CRO design partner, leveraging its expertise across clinical, non-clinical, clinical pharmacology, and chemistry, manufacturing, and controls (CMC) to enhance Weave’s AI platform and product pipeline.

As part of the deal, Parexel will hold a period of exclusivity as the only CRO licensed to use Weave’s solutions following the launch of new products. Parexel has already utilised Weave’s flagship tool, AutoIND, to prepare Investigational New Drug (IND) applications, managing to complete them 50 per cent faster than with traditional authoring timelines. These efficiency gains are expected to help sponsors initiate clinical trials sooner than current industry norms.

Weave’s AutoIND is now part of its broader regulatory workflow suite, The Weave Platform, which supports the entire regulatory lifecycle. Lindsay Mateo, Chief Commercial Officer at Weave, emphasised that while AI tools play a crucial role, human expertise remains essential for guiding context and converting AI outputs into actionable, compliant submissions.

Parexel sees this collaboration as a major step toward its vision of harnessing AI to improve the quality and speed of clinical research. By combining Parexel’s regulatory consulting strength with Weave’s automation tools, the partnership aims to uphold high regulatory standards while enabling faster delivery of life-changing therapies to patients.