Gaining compelling, actionable outcomes at the end of a clinical trial requires proper planning. Planning begins with trial design, identifying the best measures and productive, compliant sites. Equally critical is rater training at IMs and SIVs, along with administration of measures and data analysis.

Our team of specialists can serve as the centralized rater team, or devise and deliver rater trainings, compose procedure manuals, and validate captured data. We have experience in natural history, Phases 1, 2, and 3 device and drug (IND/NDA) clinical trials, working directly with subjects, sites, sponsors, and CROs to serve various subject populations from pediatric rare/orphan diseases to adult neurological and orthopedic conditions.

Measures that pertain to mobility and function are a part of the FDA Approval of a device or drug, and will contribute to marketable labeling and claims. Choosing measures which prove a drug has no unexpected, undesired effect on function or mobility is just as important as showing a drug does have positive, expected effects on function and independence. Ensuring the trial’s raters are ready to reliably capture accurate, sensitive data is critical to a trial’s success. We can also capture subject performance via high quality, reliable, compliant per 21CRF regulations video for comparative use, or to display kinematic, quality changes of mobility and function. Let us help you prospectively plan and successfully finish your clinical trial knowing the measures which contribute to physical performance, neuromotor function, mobility, and movement analysis are in good hands.