Becoming a Medical Trial Partner.

Getting your practice and patient population involved in a clinical study can be an exciting and rewarding experience. Innovation Medical Research of South Florida has partnered with many top practices throughout the state. With your help, we can provide your Patients with access to promising new treatments in an approved, safe, scientifically managed medical environment. All practices — and in some cases, Patients — are compensated for their involvement. As experts in the Trial process, IMR handles all administrative and regulatory aspects of a study. Your practice’s involvement in the actual treatment will be determined on a per-Trial basis. If you’re interested in having your practice and patients involved in a medical trial, please read on see if you have the resources and desire to conduct a medical Trial.


Steps in Conducting a Medical Trial with IMR

1. Initiation

The Trial Sponsor — whether it is a pharmaceutical company, a medical device company, a Contract Research Organization (CRO) or the National Institute of Health (NIH) — asks IMR to locate practices and patient populations that can assist in conducting a given Trial.  We then present the general Trial parameters to practices like yours. Once your practice and IMR agree to move forward, a confidentiality agreement is signed and you will appoint Principal Investigator to move the engagement to the next step.

2. Pre-Site Study

The Trial Sponsor’s local Monitor will visit your medical practice. An IMR Clinical Coordinator will also be present. The Monitor will carefully review your staff, your facility, the relevance of your patient population to the mission of the Clinical Trial, and your overall desire to be involved in the study.

3. Institutional Review Board Approval

IMR will complete the FDA Approval Form (1572) on your behalf and will send it to the Sponsor. The form will then be sent to the IRB (Institutional Review Board) along with the physician’s CV and a copy of the protocol for approval.

4. Finalizing the Contract

IMR will work with the Sponsor or their CRO to finalize the contract and fee arrangements for all parties. IMR will prepare budgets to ensure all parties involved with the Trial will be properly compensated for their time and efforts. Appropriate Patient stipends for their time and travel will be included.

5. Site Initiation Visit

The Sponsor/CRO local Monitor will meet with IMR, your staff, and the Principal Investigator to ensure that the Trial’s scope and medical protocol are completely understood, and that your practice has the information needed to make Patients comfortable with the study.  If this study involves pharmaceuticals, the Sponsor will also deliver drugs to the Pharmacist or designated Research Coordinator.

6. Patient Recruitment

IMR will help you screen Patients who are qualified and have an interest in joining the study are carefully screened using the Sponsor’s inclusion/exclusion criteria. This includes Patients from your existing population, as well as those that we have recruited and pre-screened through the IMR website and other efforts. Qualified Patients will review the Informed Consent paperwork (developed by IMR) and have a chance to ask questions about the consent process. The consent form is to be signed by the Patient and Investigator.

7. Randomization

To ensure scientific validity, IMR will enter the Trial’s approved patient population into a blind, computer-generated randomization database that assigns each Patient a trial control number. That way, neither your staff, nor IMR’s can determine whether a Patient received the treatment being studied or a placebo.

8. Treatment and Monitoring

Treatments may occur at your facility or at IMR, depending on the nature of the Trial. If injectible medications are required, they will be compounded and distributed by IMR according to the Sponsor’s protocol.  If your site is delivering treatment, the sponsor’s Monitor will visit your office on a regular basis to verify drug quantities, source documentation, temperature logs, patient data and all Trial protocols. Diaries, Labs, Radiology procedures and all clinical information will be managed and collected by IMR’s Clinical Coordinator and entered into Case Report Forms. The Trial Sponsor Monitor will review all data collected and make ongoing recommendations to the Clinical investigators as needed. The Sponsor will also convene a Safety Monitoring Board to ensure safety and accuracy of the study conduct. Safety notices will be sent to the Site. Throughout the Trial, the Clinical Investigator will report any possible adverse or unusual situations during the course of the study to IMR. IMR will forward these to the Institutional Review Board and the Trial Sponsor/IRB.

9. Study Completion

All unused medications returned by patients will be accounted for and follow-up treatment will be arranged as needed. The Sponsor/CRO will schedule a close-out visit with IMR Clinical Investigator to review the final data. Any potential Audits will be discussed.  IMR will complete budget accountability with appropriate payments made to the Clinical Investigator team.

 

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