Accelerate your submissions with an AI-native platform and deep regulatory expertise
With Parexel’s proven regulatory expertise, combined with Weave Bio's cutting-edge technology as a pioneer in AI-native regulatory automation, we are targeting increased speed to market for new therapies.
Co-developing a suite of solutions to expedite regulatory submission preparation, our teams have successfully:
- Completed Investigational New Drug (IND) drafting 60% faster than traditional authoring timelines, providing sponsors with a critical advantage in the time-sensitive process of launching clinical trials
- Co-designed New Drug Application (NDA) templates, with early performance data resulting in 60% faster authoring timelines
We continue to collaborate and expand development of other product lifecycle applications, e.g., CTAs
Parexel maintains a period of exclusivity as the only CRO implementing Weave Bio's custom-designed AI templates that are created through our collaborative development process.
Case Study
Utilizing AI to deliver regulatory documents faster
Situation
Solution
Key achievements
- Parexel sought to accelerate regulatory document preparation (particularly INDs) to help customers initiate clinical trials faster, as traditional authoring took 8-10 weeks.
- The traditional manual review process of numerous source documents with raw data created potential for human error and regulatory discrepancies that could delay approvals.
Situation
- Parexel sought to accelerate regulatory document preparation (particularly INDs) to help customers initiate clinical trials faster, as traditional authoring took 8-10 weeks.
- The traditional manual review process of numerous source documents with raw data created potential for human error and regulatory discrepancies that could delay approvals.
Solution
Key achievements
"We’re beginning this partnership by addressing an area where sponsors feel extreme urgency – early regulatory authoring and submission preparation. By combining Weave Bio'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.”
-Paul Bridges, Ph.D.
President of Parexel Consulting
Together we want to improve speed and quality to bring therapies to patients faster.
Want to achieve 60% time savings for your IND and NDA draft authoring? See Parexel’s regulatory expertise and Weave Bio's AI authoring platform in action. Please get in touch, we’re always available for a conversation – and a demo.