Study Feasibility & Rapid Start-Up

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.

 

We apply a stepwise approach to conduct an initial feasibility – typically in the RFP stage:

  • An initial medical and scientific review of the protocol or synopsis to identify study parameters that may affect the conduct and suggestions for enhancing the 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

 

Peachtree can conduct site-level feasibility and site identification – either as a stand-alone project or part of a full-service award.

Post-Award Site Level Feasibility Process

Working in conjunction with the client project team, Peachtree develops a focused and comprehensive questionnaire that allows for the full evaluation of potential investigator interest and suitability.  Sites are assessed and ranked on mutually agreed criteria across a number of key areas including:

  • Access to Patients

  • Recruitment

  • Facilities/Equipment

  • Competing Studies

  • Site Staff Experience

  • Site Capacity and Resourcing

  • Start-up Times and Processes

Our feasibility team incorporates robust follow-up (email and phone) to ensure timely questionnaire completion.

Following a comprehensive review of each investigator/site response, Peachtree stratifies the recommended sites for the study to be scheduled for either an in-person or a phone pre-study site visit in accordance with our and/or sponsor business practices.  At the site qualification visit, the information collected during the Site Identification process is confirmed and a final recommendation with respect to site selection status made.

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. 

Under the direction of the assigned Project Manager, our dedicated Start-up Team will:

  • Coordinate scheduling of pre-study site qualification visits

  • Identify and prioritize “fast-track” sites that can initiate rapidly and begin enrolling subjects

  • Coordinate the collection and review of the essential documents required for study initiation

  • Assist sites with ethics committee submissions and reviews

 

In parallel, our site contract lead will develop:

  • Proposed site budgets

  • 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. 

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.

© 2019 Peachtree BioResearch Solutions, Inc.

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