Medical Research Studies

Become a Member

Patients

• Clinical trial information
• Matching you with physicians conducting clinical trials in your area
• Identifying healthy volunteer paid clinical trials
• Providing you with health information resources about your medical condition and other areas of interest
• Provide networking opportunities with members of Patient Medical Care Network community

What can volunteers expect?

All research participants are carefully screened before they enter a clinical trial. First, a phone screening is conducted. If the preliminary criteria is met you will be asked to visit the doctors office for a in-person interview in order to obtain more information. Each research study varies depending on the nature of the study. The study team will describe what is required and expected before you decide to participate. Before any study related tests or procedures are performed, you will be provided an informed consent. The study staff will explain the details of the study, answer any questions or concerns you may have, and then have you sign a consent form. This should occur throughout the course of the study – not just at the beginning. Once you have read and signed the consent form, you are considered enrolled and you may proceed with the medical tests and treatments required by the study.

You may be required to return for more office visits and have blood tests done that you would not ordinarily have. You may be required to complete a diary or questionnaires about your symptoms. You should expect that the study staff tell you about changes that have occurred in the study including changes in the study design or requirements. You should be given the contact information of the study team including name, phone number, and email address.

Participation may or may not help your medical condition but will provide important information that will help others in the future. You may experience some uncomfortable side effects such as tiredness and headache. You may experience some unknown side effects as well. You may choose to discontinue your participation in the study for any reason. Your doctor may decide to stop your participation if he/she feels it is unsafe for you to continue in the study. You should expect to be told if something has been learned in the study that may change your willingness to participate.

There is no charge for study related office visits, tests and procedures. Most studies will compensate participants. The amount of compensation is determined based on several factors including the length of the study, number of visits and procedures, the amount of time and inconvenience. The informed consent will state the amount and schedule of payment. All participants will receive the same amount of compensation. If you are discontinued from the study, payment may be prorated.

Depending on the amount of compensation you may be required to report it on your tax return. Your participation in clinical trials will not affect your insurance or Medicare coverage for routine medical care during the study.

Investigators

There are two factors that are critical to reaching and maintaining your goals in conducting clinical trials. Effective budget negotiation so that you do not lose money and conducting studies that will pass an FDA audit, so that you don’t receive a warning letter.

Budget and Negotiation

Seasoned Investigators have experienced the ups and downs of conducting clinical trials. They have adapted to the ever changing demands of Sponsors and regulatory agencies. Adjusting to the changes can cost time and money. Sponsors and CROs make money, sometimes at the Investigator’s expense. Every site receives am initial offer from the Sponsor. Investigators should never accept the initial offer from the Sponsor without an in depth analysis the protocol. Then, accurate of calculation of staff hours and fixed costs is necessary. The Sponsor’s initial offer does not usually cover costs.

Our consultants have over 20 years of experience in calculating budgets and negotiating contracts in the investigator site, SMO, and CRO environments. We know that one size does not fit all and will develop and negotiate an initial budget that will exceed the Sponsor or CRO’s offer.

Standard Operating Procedures

Standard Operating Procedures (SOPs) is a written process that formalizes investigator responsibilities that will ensure that everyone involved in the clinical trial understands their obligations in meeting the regulatory requirements under Good Clinical Practices. SOPs is a tool for them to perform tasks uniformly, across all studies. An increasing number of Sponsors and CROs require sites have SOPs in place before selecting them for a study. SOPS are an effective tool for training staff members.

We have developed SOPs for Investigator sites that are GCP/ICH compliant. For those Investigators who have SOPs in place, we will review them for compliance and recommend revisions if necessary. We customize Investigator SOPs, taking into consideration the office workflow and ease of implementation. Well written SOPs demonstrate to auditors, the Investigators commitment conducting quality research.

Sponsors/CROs/SMOs

• We match patients with investigators conducting your studies using a free membership based network of patients interested in participating in clinical trials.
• We identify qualified investigators for your project.
• We track Investigator performance using a robust software solution
• We notify our patients of studies open to recruitment via email, newsletters, and live callers
• We track Investigator  performance and project performance with  our software solution
• We assist Investigators in meeting study enrollment targets

Study Coordinators

• Review study protocols for interest and feasibility
• Develop study budget
• Perform final review of study start-up documents
• Develop a patient recruitment plan
• Track study documents, enrollment status, and costs using our software solution
• Guidance in preparing for monitoring visits, QA audit and FDA audits