Contract Research Organization (CRO) / Contract Manufacturing Organization (CMO) Quotes
Applicants are expected to provide cost estimates for services requested from the Catalyze Program as part of their full application. It is recommended that quotes are requested from CROs/CMOs shortly after EOI submission.
Following selection, the Catalyze Coordinating Center (RTI) will verify cost estimates and qualify the CRO/CMOs prior to the initiation of the studies. The Catalyze Coordinating Center (RTI) may obtain additional bids for comparison to identify the most appropriate vendor. These bids will be obtained from vendors in compliance with federal procurement regulations.
If an applicant has been accepted into the program and previously worked with a CRO/CMO, it may be more cost/time efficient to continue working with that vendor although other vendor estimates may be obtained by the Catalyze Coordinating Center (RTI) for comparison.
The Catalyze Coordinating Center (RTI) will perform a qualification for all vendors to ensure that the vendor meets the appropriate requirements and has experience providing reports and documentation sufficient for regulatory submission.
CROs/CMOs located outside of the US will need to comply with U.S. State Department regulations as well as NIH policies. Please note, the use of international vendors will require additional clearance from the State Department and may delay the start of Catalyze services.
Services provided by CROs can range from preclinical efficacy studies, non-GLP dose range finding studies, GLP toxicology studies, or in vivo animal studies for devices. Please note that the Catalyze Preclinical Services Program will not support any GLP/GMP requests before a meeting with FDA. The applicant may request regulatory support for a pre-IND/pre-Sub meeting.
The Catalyze Coordinating Center (RTI) has expertise in toxicology, manufacturing, and regulatory strategy/regulatory submissions and will share Request for Proposal (RFP) templates that investigators can use to request quotes from CROs and CMOs.
Applicants are welcome to contact NHLBI_catalyze@mail.nih.gov to request assistance identifying potential CROs or CMOs.
If a technology already has a non-exclusive license executed with a CRO, please email NHLBI_catalyze@mail.nih.gov to initiate a discussion.