Site Feasibility
Conducting clinical trial feasibility is both an art and science. The science comes from the therapeutic area, study design, and patient population. The art comes from collation and evaluation of historical trial data and the experience to assess the ability to implement a desired protocol. The challenge for clinical researchers is to ensure a high level of clinical trial data while meeting the desired timelines. In a true sense, feasibility - of both study design and appropriate clinical sites - is a wise investment for study success.
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INITIAL FEASIBILITY STEPWISE APPROACH
Initial medical and scientific review of the protocol or synopsis to ID study parameters that may affect the conduct... suggestions for enhancing specifics
Utilize Trialtrove® to identify similar studies (Indication, Phase, Subject Population) for benchmarking
Cross-reference Trialpredict® to evaluate subject accrual rates from benchmark studies and compare to the desired accrual rate in the RFP
Identify potential sites from our experience and utilize Sitetrove® to expand reach
Augment findings with additional databases and information sources for further site identification
SITE LEVEL FEASIBILITY
RAPID STUDY START-UP
The success of a start-up is due to seamless communication between the project team and dedicated specialists working in a synchronized fashion all with the same priority – rapid start-up of the clinical program.
YOUR DEDICATED START-UP TEAM
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Coordinate scheduling of pre-study site qualification visits
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Identify and prioritize “fast-track” sites that can initiate rapidly and begin enrolling subjects
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Coordinate the collection and review of the essential documents required for study initiation
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Assist sites with ethics committee submissions and reviews
YOUR DEDICATED SITE CONTRACTS TEAM
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Site contract lead starts the budget / contracting process with each site - communicating the status regularly (at least weekly during start-up)
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Site contract templates
As sites are qualified, the site contract lead starts the budget and contracting process with each site and regularly communicates the contracting status on at least a weekly basis during start-up. Contract timelines can vary depending on factors such as, contract template used, legal requirements, budget parameters, ability to negotiate certain fallback language and the availability of sites legal reviewers and respective signatories. The implementation of the dedicated contracts team, their coordination, and proactive planning reduce the overall contract negotiation time.
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The clinical project manager is kept apprised of the status and progress of the collection of required documentation and contract execution. Upon completion, the project manager will approve supplies shipment and the assigned CRA is notified of initiation.