July 14, 2021
Clinical Outcome Measures: Implementation Matters
Once you’ve chosen your clinical outcome measure, your next step is to decide how the data will be collected. When you’re thinking about measures used for rare neuromuscular disorder clinical trials, this step is complex. You’ll need to decide who is qualified to perform the assessment and to score the assessment, what equipment and space is required to administer it, and how everyone will be trained. In rare disease clinical trials, any one site might have long gaps between trial visits. How will everyone stay up-to-date on their training?
TRiNDS Study Measurements provides specialized neuromuscular expertise to help researchers choose and implement the most appropriate study outcomes. Our experts help researchers select the appropriate outcome measures for the planned study population during protocol design. We create training plans to guide how central trainers and site staff are trained to administer the outcome measures. During the study, we provide central data review to monitor whether site staff are administering and scoring the measures correctly over time. Our team provides refresher trainings and continuing education to study teams to keep their skills current throughout the study. We match our services to the unique needs of every trial sponsor and their sites to maximize data quality without duplication of efforts.
TRiNDS is a contract research organization (CRO) dedicated to conducting rare and neuromuscular disease research. We are currently accepting new clients developing products for rare disease orphan disease, and neuromuscular patient populations. Contact TRiNDS today to request a quote.