After determining the type of study the Sponsor needs, one of our sales account executives will prepare a proposal. Each proposal will describe the purpose, study scope, neutralization, price and terms for that particular study. The proposal will be sent to the Sponsor for approval. Once the proposal is returned signed with proper information regarding sponsor’s billing and accounts payable, the development of the study protocol will begin.
The study protocol outlines the test methods and other significant details that meet the purpose stated in the signed proposal. The following are outlined in the protocol: sponsor, testing facility,key personnel running the study, test methods, product application procedures, calculations/statistical analysis, inclusion/exclusion criteria for clinical studies, etc. Once the protocol has been approved by all necessary personnel within BioScience, a final protocol will be sent to the Sponsor for approval. The acceptance page must be returned with the Sponsor’s approval before BioScience can move forward with testing.
While the protocol is being developed, the sponsor will send the necessary test materials to BioScience. The quantities needed for testing will be determined by the sales account executive and study director. The following documentation must accompany all products for each study:
Gallatin Institutional Review Board (GIRB) Approval of Clinical Protocols:
For clinical studies involving human participants, the FDA requires each individual protocol to be approved by an independent institutional review board. The GIRB reviews each protocol and monitors each study throughout the study process to protect the rights and welfare of human participants during clinical research. Participant recruitment CAN NOT begin until the protocol has been approved by the GIRB.
Once a finalized protocol has been approved and all necessary products have been received, testing will begin. For the duration of testing, any adverse and unexpected events will be promptly communicated to the Sponsor.
Once all raw data has been collected, the Study Director will begin the statistical analysis of the data as stated within the Protocol. At this point, the sponsor can request to review preliminary data.
As outlined by Good Laboratory Practices (GLP), regular in-phase quality assurance audits of the critical testing procedures will be conducted. On completion of testing, the Quality Assurance Unit will perform an audit of the raw data and the Final Report in its entirety. Information regarding these specific audits can be found within the final report.
Upon completion of testing and statistical analysis, a final report will be issued presenting the results in a clear and concise manner. Any questions regarding the information present in the final report can be answered by the study director or the sales account executive.
I knew about Bioscience quite awhile before I came in to register. Why did it take take me so long? Probably just having no idea what to expect. Well, here is what to expect: Great subject recruiters who will help you decide if a particular study is right for you, and great laboratory staff who patiently and efficiently guide you through the requirements of the study. Try it! It is a wonderful way to make some extra money.
After 7 years and moving to a new building I can honestly say Bioscience is my home away from home. Great people, easy studies to participate in and a great way to earn extra cash. I encourage everyone to try it at least once!