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Ocean Blue Medical Research Centerhas been recognized by virtually all of our clients as providing accurate, insightful and comprehensive Protocol and Country Feasibility Assessments. We take pride in maintaining the highest standards as our assessments are used as the basis for our recommendations on protocol design, operational execution and geographical placement of the study.
Our Feasibility Department is a globally distributed group within Medical and Scientific Affairs (MSA). Feasibility Assessments are led by the Chief Medical & Scientific Officer and by our Senior Vice Presidents of Medical & Scientific Affairs. The combined medical and scientific expertise, with our global reach, ensures that we provide you with the best possible solutions to your program.
Feasibility data is analyzed, summarized and graphically presented in a Feasibility Assessment Executive Summary document that clearly provides supporting data and facts, to assist you in the optimal development of your clinical research program. Based on the results of the survey, which is conducted in a blinded fashion, the Executive Summary provides information and data driven suggestions/recommendations, as follows:
Our Feasibility Assessment is a formal and comprehensive quantitative exercise accompanied by a qualitative interpretation of the data.
Our practice is to conduct blinded feasibility assessments and specific details of the client and intervention are not revealed to sites under survey. A confidentiality agreement with sites is therefore not required, helping to expedite this initial stage of the process.
As feasibility assessments are intended to serve as both a data gathering mechanism as well as a problem-solving exercise, practical experience with cultural, medical and regulatory perspectives within countries of interest is mandatory.
A detailed web-questionnaire followed by clarification phone calls or onsite visits from our local teams form the basis for this review and, attempt to capture all information relevant to execution of the proposed study. This data driven assessment commonly includes questions that appear extraneous to the protocol as presented but are, from experience, informative regarding site capability and commitment.
All questions are crafted in a fashion that permits an assessment of site sophistication in the area of interest. Additional design options that might be considered in the final protocol are added to inform the survey prospectively. For example, our MSA team will commonly anticipate possible modifications to the protocol that a sponsor could introduce based upon the results of the survey and will prospectively query sites on those possible modifications.