How the Process Works

First Step – Selecting the Right Study
for You

We review potential clinical research studies with you to choose one you are interested in and believe you have the patient population to support. Examples of possible clinical research trials include investigational medications for Crohn’s Disease, Hypertension, Obesity, Insomnia and High Cholesterol.

When a clinical research study is chosen, ECR begins all of the paperwork required by the sponsor (pharmaceutical company) to secure the trial such as feasibility questions, regulatory documentation, contract and budget negotiation, etc.

Second Step – Investigator Meeting

Once the study is awarded to the site investigator, the physician must attend an investigator meeting (which is a 1 day training usually held in another state) that is planned and paid for the by the sponsor. At this meeting, the physician and the ECR coordinator are trained on the protocol and investigational drug.

Third Step – Identifying Patient Participants

When the study begins, the investigator must find suitable patients to participate in the clinical research trial using the eligibility criteria taught at the investigator meeting.

Once the investigator identifies a patient, the investigator discusses the trial opportunity with the patient and then notifies ECR of the potential patient.

A coordinator from ECR contacts the patient and goes into greater detail about the study. The coordinator also requests the patient’s medical record from your practice and ensures that the patient meets all eligibility criteria. Then the patient is screened for the clinical research trial at the ECR site in Belton, MO.

Fourth Step – The Clinical Research Events and Exams

ECR performs all protocol-required events except the physical exams. These are done at your office, scheduled and performed in your usual manner.

During protocol-mandated visits at our office the patient will have lab work drawn, vitals taken, ECGs performed, and receive study medication. The patient may also need to complete questionnaires or complete daily diaries.

Once a week the investigator is sent progress notes, ECG readings, lab reports, etc. on your study patients to review, interpret, and sign.

ECR will be available to patients by phone 24/7 regarding non-medical issues. The patients call the investigator’s regular office for medical issues and their calls are handled per the office’s usual practice.