To Our Research Clients
A client’s research problem will be given the highest priority involving a five-step approach:
Careful consideration given to the materials and objectives of the intended clinical program by first organizing a concise hypothesis, general study objective, discovery strategy, and proposed plan of action, report.
Test substance/material is thoroughly researched – what is known and not known, as well as any potential acknowledged uses or known toxicity finding.
Discussion with the investigator and those involved in the research, on the findings and decide on an appropriate course of action.
Preparation of a protocol, encompassing practical objectives, will be prepared provided the research has indicated that a Clinical Trial it is warranted.
Presentation of the data to the client once the study has been executed.
While many of today’s treatments for life’s various maladies are rife with toxicity—occasionally producing severe adverse events, our in-house research will always try to discover new and innovative treatment substances that are non-toxic.
Research – Clinical Study
It all begins with non-clinical background research
Before any project is ready to fly off the drawing board, a significant amount of preliminary background research must be done. St. Anthony’s key people will listen to your ideas, use the resources at its disposal, research and generate a report outlining the known information of your substance/supplement as well as the feasibility of proceeding with your project, as you have envisioned it.
Often times, once the preliminary research has been completed, the initial project or product may need to be revised. St Anthony’s has the expertise necessary to work with you and your vision to accomplish this.
Check And Double Check
Once your nutritional substance, intended for future clinical research work, has successfully undergone:
- material purity tests,
- final formulation check,
- and successful toxicology testing,
It can now be considered for a clinical study.
Designing Your Clinical Study
Working with your objectives, St. Anthony’s research staff will design a clinical program. Once your clinical study draft is finished, you will review and approve the objectives in the protocol.
A Physician And A Center Is Chosen
If you have an Institutional Review Board (IRB) and study center ready to go—great! St. Anthony’s will work with these people to ensure your study gets underway as quickly as possible.
Don’t have these resources? No problem.
Let St. Anthony’s locate a center for you. Study centers exist all over the USA. It is simply a matter of finding one that matches your needs and budget.
We can also handle the submission of the final document to an independent IRB for review and approval. The IRB will then review it, according to their stringent criteria for safety, and ethical use of humans as test subjects.
There is no guarantee that any IRB board will approve a study; however, St. Anthony’s will make every effort to work with the IRB to resolve any issues, should they arise.
Approval And Execution Of Your Clinical Study
Once your clinical study has been given the ‘Green Light’ by the IRB, St. Anthony’s will work directly with you and a facilitator to coordinate clinical study recruiting and execution activities and ensure that the study moves along as smoothly as possible. We liaise with the contact person for your clinical study throughout the entire study period, and provide brief updates on your study’s progress toward completion.
Once the study has ended and all data has been gathered, it will be checked and assembled into a single report for you.
At this point, you may choose to keep the data in-house and confidential. If this is your objective, your project is now finished.
If however, publication is your final goal, St. Anthony’s research writers will work with you and your publisher to provide a finished manuscript. If you haven’t chosen a publisher, St. Anthony’s can submit your research to the publisher of your choice or one of many scientific outlets that exist today.