Phone-Screening: 

You will receive a phone call from your local GMI site, during which you will be asked questions to determine if you qualify as a candidate. Once it is determined that you are a suitable candidate, you will be scheduled for a pre-screening visit.

Pre-Screening Visit: 

This will be your first visit to the clinic. During this visit, the team will conduct initial evaluations to assess the severity of your condition and determine whether you are eligible to participate in the trials.

Screening Visit:

During your next visit to the clinic, the team will conduct initial evaluations. Many studies require our qualified staff to perform an Electrocardiogram (ECG) and blood work at this visit. The results of all evaluations will be sent to the sponsor of the trial for approval.

 

Baseline Visit:

If approved by the sponsor, the baseline visit is where you will be randomly assigned to the trial. Randomization is typically computer-generated by the study sponsor and is often double-blinded, which means that neither you nor the Study Coordinator will know if you are receiving the treatment or a placebo. During this visit, some of the evaluations that were conducted during the screening visit will also be performed.

 

Follow-Up Visits:

The number and frequency of visits, as well as the duration of the trial, can vary greatly depending on the sponsor. We will do our best to accommodate your schedule to make the visits as convenient as possible. Most follow-up visits will involve evaluations of the treatment’s performance and your overall well-being, as well as assessments of your condition’s improvement with the medication. You may also need to have routine bloodwork done.

 

Post-Conclusion Visit:

After completing the trial, you will be asked to come in for one final visit to the office for evaluations and bloodwork. This appointment is to ensure that you are well after the trial and to assess how your condition has been since you stopped the treatment.

 

Open Label Extension:

Many trials have an open-label extension, which is when you can continue to receive the study treatment if it has improved your condition. The purpose of an open-label extension is to determine the long-term effects of the treatment on the condition. When you enter the open-label extension period, the trial