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NSF Regenerative Medicine Engine

Product Trials Catalyst

One approval process. 67 hospitals. More than 1,000 outpatient sites.

The Product Trials Catalyst gives product developers access to a statewide clinical network through a single IRB and contract approval process — so trials start sooner and enroll faster.

67

hospitals

1,000+

outpatient facilities

1 IRB · 1 contract process

instead of negotiating site by site

The challenge

Two barriers slow technology translation

Site-by-site negotiation

Sponsors must negotiate separately with each and every trial site — repeating ethics reviews, contracts and budgets before a single patient can enroll.

Recruitment on deadline

Finding and enrolling enough eligible participants on time is one of the most common reasons trials stall.

The impact

80%+

of trials fail to meet recruitment timelines

~30%

of sites fail to recruit even one participant

Millions

of dollars per day in lost opportunity for sponsors, as recruitment delays add months to years to product development
Sources: Desai, M. (2020), “Recruitment and retention of participants in clinical studies: Critical issues and challenges,” Perspectives in Clinical Research, doi.org/10.4103/picr.PICR_6_20; Applied Clinical Trials (September 2026).

How it works

One front door to a statewide network

The Product Trials Catalyst replaces dozens of separate negotiations with a single path to approval.

1

Single IRB review

One institutional review board approval covers participating sites across the network.

2

Single contract approval

One contracting process replaces separate negotiations with each trial site.

3

Network-wide access

Reach patients at 67 hospitals and more than 1,000 outpatient facilities to meet enrollment targets.

Results to date

Already moving products forward

3

trials supported by the Product Trials Catalyst

1

product achieved FDA clearance, with plans for an additional trial

$4.4M

in gross income to date (approximate)

Bring your next trial to North Carolina

Talk with the Product Trials Catalyst team about your product, timeline and enrollment needs.
The Product Trials Catalyst is a program of the Regenerative Medicine Engine in North Carolina, a U.S. National Science Foundation Regional Innovation Engine.

This material is based upon work supported by the U.S. National Science Foundation under Award No. NSF-2315654.