Clinical Services

Real-world experience, thoughtful guidance.

We provide thoughtful guidance and quality clinical trial services to clients who require expertise in the efficient development of novel medical products and therapies.

Human clinical data may be needed to support regulatory submissions, publications, or simply to advance knowledge of diseases and associated treatments. We can help you understand when clinical data may be necessary and strategize how to collect them most efficiently. In addition, we have significant experience executing the resulting trials.

Our personnel have managed clinical trials in a variety of disciplines, including interventional radiology/vascular surgery, wound care, soft tissue surgery, cardiology, urology, otolaryngology, head and neck surgery and cell therapy. We have also designed feasibility trials for novel treatments of a variety of diseases, including aortic aneurysms, aortic dissections, peripheral vascular disease and critical limb ischemia, chronic dry eye, ventral hernia, hiatal hernia, critical care and chronic diabetic wounds.

Clinical consulting services

CLINICAL PROTOCOL DEVELOPMENT

The trial protocol is the blueprint for carrying out your trial. A well-written protocol is essential for gathering the necessary information about your product efficiently and cost-effectively.

eCRF CREATION, IMPLEMENTATION AND MANAGEMENT

Electronic case report forms (eCRF), accessible by any computer with internet access, are worksheets used to capture the trial data. The eCRFs should be simple and easy to use, with unambiguous questions and intuitive work flow. The data entered by a trial site are mapped directly into the study database and are monitored for completeness and quality assurance.

CLINICAL SITE ASSESSMENT

Enthusiastic, adequately staffed, expert clinical sites are essential to timely enrollment of patients and collection of reliable trial data.

DOCUMENT PREPARATION FOR INSTITUTIONAL REVIEW BOARD (IRB) SUBMISSION

IRBs review the trial protocol, Investigator’s Brochure, and any documents that will be seen by the trial subjects (e.g., informed consent form, questionnaires, informational cards) before rendering their opinion on the acceptability of a clinical trial.

CLINICAL SITE TRAINING AND SUPPORT

Trial sites must be trained in the use of the trial product, the proper collection of trial data, and data reporting requirements.

CLINICAL TRIAL IMAGING CONSULTING

Often the necessary information about a medical product can only be gleaned from a patient imaging exam (e.g., X-ray, CT, MRI). To obtain reliable data, the imaging must be conducted and analyzed in a consistent way, even across multiple study sites and investigators.

TRIAL REPORTING AND FINAL DATA OUTPUT

The data are collated from the trial database and summarized to create trial progress reports,or analyzed to produce trial results.

TRIAL CLOSEOUT

Each trial site must keep copies of the proper documentation and submit a notice of trial closure to its IRB, usually including a final trial report generated by the trial sponsor that summarizes the trial results.

CUSTOMER SERVICE

MED Institute utilizes years of experience with trials ranging from first-in-man proof of concept to multinational, multicenter, controlled pivotal trials to conduct clinical trials efficiently, with an emphasis on quality. Study documents and procedures are carefully designed to ensure a quality trial that produces the information needed to progress with the development of the product or treatment. MED focuses on building relationships with the clinical trial sites to inspire the collection of timely and accurate data that are pertinent to the goals of the trial.

For more detailed information, please contact:

Mike Otlewski
Clinical Program Scientist
765.337.3754
Bill Voorhees
VP/Chief Science Officer
765.418.1200