Clinical Services

Real-world experience, thoughtful guidance.

MED Institute is a full-service contract research organization (CRO) that provides engineering, regulatory, and clinical trial consulting services. 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 through investigative clinical research.  We can help you understand when clinical data may be necessary, determine exactly what kind of data will be most useful to meet your goals (e.g., FDA approval), and strategize solutions for collecting them most efficiently. In addition, we have significant experience executing the resulting clinical trials, ranging from small 5-patient feasibility studies to multinational, controlled pivotal trials to post-market registries.

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, rheumatology, endocrinology, 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. Writing an ineffective protocol will adversely affect your development timeline and will waste money. This is why MED Institute supports clients early in the clinical study design and trial protocol development stage. MED works in collaboration with experts and study stakeholders to determine reasonable performance goals, to determine appropriate examinations and procedures, and to define the right patient population to target via the trial eligibility (inclusion/exclusion) criteria. A well-written protocol is essential to maximize risk in gathering the necessary clinical data about your product.

eCRF CREATION, IMPLEMENTATION AND MANAGEMENT

Web-based electronic case report forms (eCRF), accessible by any computer with internet access, are worksheets used to capture the trial data. Data entered into the eCRFs are mapped directly into the study database in a logical way that allows for straightforward data analysis. Our eCRF system is highly customizable, to suit individual project needs. For example, our system can include automated, instant randomization so clinical sites may enroll subjects any time day or night without having to wait for the sponsor or CRO to determine which treatment to provide to the patient.

The eCRFs should be simple, standardized, and easy to use, with unambiguous questions and intuitive work flow. Poorly designed eCRFs lead to unnecessary delays and potentially inaccurate data. MED Institute creates eCRFs that ask the right questions to support your trial's goals, in a simple and intuitive way. MED uses advanced Business Logic to add automated system checks and specifications to eCRFs to help improve data quality by reducing errors during the data collection process. Built-in data integration tools are used to track the study progress across myriad metrics, which allows for constant monitoring of performance goals and the ability to mitigate potential issues before they grow.

CLINICAL SITE ASSESSMENT

Enthusiastic, adequately staffed, expert clinical sites are essential to timely enrollment of patients and collection of reliable trial data according to Good Clinical Practice. Site assessment visits prepare the principal investigator (PI) and site staff to meet all requirements for conducting each study. At the conclusion of the visit, the PI will know what specific steps, if any, are needed to meet the applicable requirements. MED Institute's experience with trial sites around the world has taught us how to evaluate potential trial sites and the right questions to ask to determine the best fit for each clinical trial.

DOCUMENT PREPARATION FOR INSTITUTIONAL REVIEW BOARD (IRB) SUBMISSION

IRBs are convened to protect the health, safety, and welfare of patients. Research involving human subjects may only be carried out if an IRB approves the research plan. 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, recruiting materials) before rendering their opinion on the acceptability of a clinical trial. If a central IRB is appropriate for your trial, MED Institute can prepare and submit the trial application. If a study site needs to submit to its own individual IRB, MED helps to support the site staff in preparing their application in order to maximize the chances of getting timely approval.

CLINICAL SITE TRAINING, SUPPORT, AND MONITORING

Trial investigators and trial site research coordinators must be trained in the use of the investigational product, the patient informed consent process, the proper collection of trial data, and data reporting requirements. Without effective site training, trial data may be missed, collected improperly, or reported incorrectly. Proper use of the investigational product is imperative to minimize patient safety risks. Training also helps sites conduct the trial in accordance with the regulations and ethical guidelines. Ultimately, if trial data are untrustworthy for any reason, or are dismissed by the FDA due to compliance concerns, the entire endeavor becomes a waste of time and resources. MED Institute focuses on comprehensive site training with continuous performance monitoring to ensure study sites are providing the highest quality data. Intermittent retraining is performed as indicated to ensure site performance throughout the duration of the trial. To ensure the data integrity, clinical research associates (CRAs, clinical study monitors) are used to verify the submitted trial data and to verify the trial sites are conducting the trial in accordance with the trial protocol and all applicable regulations and ethical standards, such as Good Clinical Practice (ICHGCP).

DATA MONITORING, REPORTING AND FINAL DATA OUTPUT

MED Institute tracks the trial data as they are submitted, to monitor whether trial sites are submitting complete and timely data. This is vital to correct any performance issues as early as possible, and because certain data (such as patient serious adverse events) are subject to strict reporting requirements. MED is constantly vigilant for such occurrences to ensure required reporting timelines are met. MED collates data from the trial database and summarizes them to create periodic trial progress reports or to perform statistical analysis to produce the full 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. MED Institute ensures that sites have the necessary documentation and the staff are aware of their post-trial responsibilities. In cooperation with the sponsor, MED creates the final trial report and helps the sites meet every other requirement to close out the trial to the IRB's satisfaction.

CUSTOMER SERVICE

MED Institute has years of experience with trials ranging from first-in-man proof of concept to multinational, multicenter, controlled pivotal trials to conduct clinical trials. We know how 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 trial sponsors to identify the primary and ancillary goals for each trial and 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