Site & Investigator Appraisals

To achieve the specified numbers of evaluable subjects, the selection of sites is critical to the success of the study. A good feasibility survey must be undertaken at an early state in the selection process to ensure that a study can be conducted in the country or at the site of choice. The survey will gather and analyze data on the availability of potential subjects fulfilling the inclusion and exclusion criteria, realistic recruitment rates within stated timelines, current and comparator treatments, competitor studies and regulatory and ethical issues. The initial feasibility survey may also check investigators for proven experience in trials in a particular indication. The questions asked must provide sufficiently well-founded responses to permit a decision on which countries and sites are to be used.

A good feasibility will make an immeasurable difference to a study. The monitor will feel comfortable about the site’s capabilities and there should be fewer drop-outs and fewer site replacements due to poor or no recruitments. The feasibility survey should complete those parts of the selection process that can be performed by telephone, fax and e-mail prior to visiting the site for a site selection visit.

We at Consortium Clinical Research deploy our technical expertise and networking skills in ensuring that the best picks are done out of the massive pool of credible sites and interested investigators who are available in the country. Thus, we add value to the drug development process of a sponsor, by performing meaningful evaluations to understand the status quo of various sites’ performances in a particular clinical study under consideration.

Information has been referenced from Principles of Clinical Research, 2001.