Pearl Pathways

University-wide Agreement with Pearl Pathways

To facilitate our faculty’s ability to enter into a contract with a Contract Research Organization (CRO), the Office of Research Protections, in cooperation with the University’s Purchasing Services Department, has recently executed a Master Services Agreement with Pearl Pathways for clinical trial support such as monitoring, regulatory support, and project management.

Benefits of utilizing these University-wide Contracted Suppliers: 

• Elimination of the requirement for a separate contract for each project involving these services.  
• No-cost access to the CRO for assistance in determining the scope of work required, including respective cost estimates. This will ensure that required services are identified and are fiscally feasible. 

Procedures

For investigators seeking access to the Pearl Pathways's Services:

1. The investigator should contact the Pearl Pathways representative, listed below in the "Supplier Contacts" section, to set up a consultation to establish the Statement of Work (SOW). 

2. Pearl Pathways provides a SOW, complete with pricing. In the SOW, Pearl Pathways specifically refers to the University-wide Agreement (also referred to as the Master Services Agreement or MSA) as the governing terms for the quote.

3. The department or investigator signs the SOW verifing that the University-wide Agreement (also referred to as the Master Services Agreement or MSA) has been properly cited.

4. The department submits either a “non-catalog” form or a “blanket/standing order” form (i.e., if there will be recurring services wherein Pearl Pathways 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).

5. Purchasing Services will review and approve the requisition. A PantherExpress System purchase order is generated and sent to Pearl Pathways along with the attached, signed SOW.

6. Upon receipt of the invoice, the department submits it to Payment Processing with the purchase order number clearly visible on the invoice.

Note: for federal grants, you must obtain quotes from three different CROs.

If you have questions related to this University-wide Agreement or the respective purchasing procedures, please contact the "University of Pittsburgh Contact" listed in the section below. Faculty acting as the sponsor of an IND or IDE may contact IND and IDE Support at IIS@pitt.edu for information on support provided by the University. 

Information about the requirements to conduct a multicenter clinical trial associated with a faculty sponsored investigational new drug and investigational device exemption and the transfer of regulatory obligations to a CRO can be found on the IND and IDE Support website.