Study Process

BioScience Laboratories Study Process:

  1.  Proposal Development and Approval
  2.  Protocol Development and Approval
  3. Test Material Submission
  4. IRB Approval for Clinical Protocols
  5. Testing
  6. Statistical Analysis
  7. Quality Assurance Audits
  8. Final Report

PROPOSAL:

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.

PROTOCOL:

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.

TEST MATERIAL SUBMISSION

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:

  • A Sponsor Sample Submission Form 
  • Material Data Safety Sheets 
  • Investigational Brochure/ Product Ingredient Lists (for clinical studies)

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.

TESTING:

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.

STATISTICAL ANALYSIS:

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.

QUALITY ASSURANCE AUDITS:

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.

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.


What People are Saying...

John (Dyba), seldom in recent memory have I experienced the level of integrity and commitment we have experienced working with you and your team.  Please pass our gratitude on to your team and tell them how much we enjoy working with such a professional organization.”

Russell Altman, Owner, Beneficial Solutions, LLC

We have been working with BioScience Laboratories for the past few years on the development and testing of a range of revolutionary new products.   The technology team at BSL has been trustworthy partners, helping us to develop and advance testing protocols that meet stringent FDA requirements.  Their guidance has been expert and their testing laboratories have provided timely and detailed results.   We greatly value the support and technical leadership provided by BSL."  

Mr. Michael S. Zedalis, SVP - Science & Technology, Ansell