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 various technology platforms to identify similar studies (Indication, Phase, Subject Population) for benchmarking
Cross-reference with additional data 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 other methods 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.

Develop Site List

Distribute Focused Feasibility Survey

Evaluate Returned Surveys

Select Sites For Qualification

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:

Our feasibility team incorporates robust follow-up 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.

Access to Patients
Recruitment
Facilities/Equipment
Competing Studies

Site Staff Experience
Site Capacity and Resourcing
Start-up Times and Processes