New University-wide Contracted Supplier Providing GLP Compliant Study Services
In conjunction with the Office of Research Protection, we are pleased to announce a University-wide Contracted Suppliers agreement with Charles River Laboratories (CRL) for the conduct of Good Laboratory Practice (GLP) compliant, non-clinical safety (i.e., pharmacology/toxicology or biocompatibility) studies.
As the largest provider of GLP study services in the country, CRL provides a wide breadth of respective expertise to address most of the needs of faculty involved in the clinical translation process. This agreement provides the following benefits:
- Eliminates the requirement for a separate contract for each project involving the purchase of GLP-compliant studies performed by CRL.
- Transfers of unique (i.e., developed at the University) laboratory animal models (e.g., “knock-out” models) and test articles between the University and CRL for the purpose of the GLP studies performed under this agreement are exempt from the requirement for a Material Transfer Agreement (MTA).
- Investigators involved in the clinical translation of experimental drugs and devices have no-cost access to CRL’s Scientific Advisory Services for assistance in the design of appropriate GLP-compliant, non-clinical safety studies, including respective cost estimates. This information is important for the preparation of FDA submissions (Pre-IND meetings, Q-submission meetings, IND and IDE applications) and for identifying funding sources for these required studies.
Procedures for leveraging this University-wide Contracted Supplier Agreement:
For investigators seeking access to CRL’s Scientific Advisory Services for assistance in the preliminary design of GLP-compliant studies:
- Email (email@example.com) the Office for Investigator-Sponsored IND and IDE Support (Office of Research Protections) to complete a CRL Program/Science Review form and initiate contact with a CRL representative.
For the purchase of GLP-compliant studies performed by CRL:
- The investigator’s responsible department will email (firstname.lastname@example.org) to initiate contact with a CRL representative so that a request can be made for a Statement of Work (SOW).
- CRL provides a quote for the SOW and, in the SOW, CRL specifically refers to the agreement as the governing terms for the quote.
- The department signs the SOW, verifying that the agreement has been properly cited.
- The department submits either a “non-catalog” form or a “blanket/standing order” form (i.e., if there will be recurring services wherein CRL will bill multiple times) to the PantherExpress System. The signed SOW is attached to either form as an “External Attachment”. Note: there is no requirement to submit a Directed or Sole Source Justification Form (DSSIJF) or a Certificate of Liability Insurance (COLI).
- If the value of the SOW is $10,000 and less, the department approves the requisition internally. Once the requisition is approved, a PantherExpress purchase order is generated and sent to CRL along with the attached, signed SOW.
- If the value of the SOW is greater than $10,000, the department creates a requisition for routing to Purchasing Services, which reviews and approves the requisition. A PantherExpress purchase order is generated and sent to CRL along with the attached, signed SOW.
- Upon receipt of the invoice, the department submits it to Payment Processing with the purchase order number clearly visible on the invoice.