Contract Research Organizations: Outsourced Trials, Outsized Problems
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The Selection and Use of Contract Research Organizations
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Contracting with Contract Research Organizations (CROs)
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Selection Criteria for Study Placement at Pre-Clinical Contract Research Organizations
A person or team closest to the science or the person responsible for leading the program team or, in a small company, the person managing the clinical trial s often are best positioned to lead this effort. A champion will coordinate the entire process across multiple functions project management, medical, finance, clinical operations, etc. A committee that is composed of multidisciplinary leaders often can determine the CRO that is the best fit for the organization.
Not all CROs are aligned with your organizational culture, practices, or expertise, so it is a best practice to define these parameters. The selection committee must also have a vested and committed interest in this process. Depending on the size of the organization, the committee may want to define and agree on a communication strategy. This ensures the workflow is moving ahead as per plan and that all members are accountable for their roles and tasks. Additionally, good planning establishes how to maximize core assets and utilize internal resources, supplemented with external resources.
For example, the sponsoring company will establish how the investigator site contracts will be negotiated and who will legally be bound by the agreement s. CROs bidding on the work need to know exactly what tasks they will perform in order to provide their best approach.
By further defining the scope of the services being procured, whether full service or partial service, companies create a strategic sourcing approach for the clinical trial. A competition is not a new concept, but how you conduct the competition is key, especially if the project is partnered with another commercial entity or federal agency i. Also, as the committee considers long-term planning or portfolio management, it seems logical to maximize efficiencies with relationship management.
How can teams reduce cost and time in this repetitive process?
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Commercial procurement models generally take one of three forms. The preferred provider model, which creates a more collaborative relationship with a CRO, ensures repeat business and allows for streamlined buying power. Another model is used when sponsors want to harness innovation to select the best value-added solution.
Making these requirements clear to CROs that range from generalists to specialists with partial- to full-service clinical research functions allows the CRO procurement filter process to be maximized for best fit.
- Selected works in applied mechanics and mathematics;
- Imagination and the Arts in C.S. Lewis: Journeying to Narnia and Other Worlds?
- Selection Criteria for Study Placement at Pre-Clinical Contract Research Organizations;
- KEY INDUSTRY INSIGHTS.
- Boston (City Guide) (5th Edition).
- After the Rabbit (Waldo Rabbit, Book 2);
What does this mean for the selection committee? What level of detail and criteria are needed?
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The RFP will be addressed in Part 2 of this series, but before you can create an RFP, the committee must define criteria for selection. Matching chemistry like perception or perceived value is important on the surface, but the real measures of potential performance are the following criteria. Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Find out more in SAM Sather's webinar:. According to Comprehend, 3 a clinical intelligence software provider, the three most common overlooked selection criteria are transparency, collaborative partnership, and real-time responsiveness.