The best time to prepare for regulatory change is before the CRO bid defense.
At the end of September, I wrote about FDA’s Expedited IND Pilot and its ambition to hasten first-in-human development.
Now, the 2026 Unified Agenda adds another chapter to that story.
FDA is considering changes intended to modernize and streamline Phase 1 IND requirements, including process, content, format, and sponsor responsibilities. It is also progressing a requirement for most US institutions participating in multisite cooperative research to rely on a single IRB.
These are planned regulatory actions, not current requirements, but they are directional signals sponsors should not ignore.
Together with the Expedited IND Pilot, they point toward a development model in which regulatory strategy, scientific preparation, ethics review, contracting, and site activation move as connected workstreams rather than sequential chapters. Under the pilot, qualified research institutions may support IND preparation and rolling review while IRB review and site-activation activities proceed in parallel where appropriate.
That changes the CRO-selection question.
The traditional RFP asks whether a CRO can activate sites, enroll participants, monitor performance, manage data, and deliver the database.
Those capabilities matter, but sponsors must also ask whether the CRO can help navigate the path to the study.
Can the proposed team:
Integrate clinical, regulatory, nonclinical, and CMC perspectives?
Anticipate gaps before they become regulatory questions or clinical holds?
Coordinate IND preparation, IRB review, contracting, and site readiness without losing control at the seams?
Explain how its systems and governance will adapt as requirements evolve?
Provide the people named in the bid defense, with the authority and judgment to make the model work?
Weak integration becomes visible sooner when workstreams move in parallel, and a handoff missed on Monday can become a delay by Friday.
A faster regulatory pathway raises the cost of choosing a partner whose scientific, regulatory, ethics, and operational capabilities exist only as separate boxes on an organizational chart.
The best CRO-selection processes will test more than capability.
They will test connectivity.
Because speed is not a promise made in a proposal.
It is an operating model built before the work begins.
