Every successful clinical trial has an effective and competent clinical operations team operating from behind the scenes. Clinical operations teams need to meet several different criteria to be successful. Experience in trial management, clinical trial site selection and start-up, ethical committee review supervision, and time and budget management are all integral to a successful clinical trial. The steps involved in rare neuromuscular disease (NMD) trials are more complex, involve more stakeholders, and require teams with specialized experience.
Rare NMD diagnoses have standard clinical care practices which add complexity to clinical trials. Rare disease clinical care standards are often less well-defined than more common diseases. Complex rare diseases involve more concomitant medications, are accompanied by extensive medical histories, and often require subspecialists. Eligible participants are also more difficult to locate, making high retention an essential component to a trial’s success. These considerations mean that clinical trial sites must work harder to enroll and retain participants while completing more study procedures during each visit.
TRiNDS Clinical Operations offers specialized services for rare NMD research. Our team provides experienced and specialized project management, utilizing our previous experience to recruit and manage the clinical sites you need for your project’s success. Our central clinical research associates (CRAs) are specially trained to conduct monitoring visits with an understanding of the clinical context of your study’s protocol. TRiNDS strives to provide exceptional service for our trial sites, supporting them from study startup through closeout and ensuring high-caliber data collection along the way.
TRiNDS is a contract research organization (CRO) dedicated to conducting rare and neuromuscular disease research. TRiNDS offers expert research and clinical trial services to sponsors and researchers around the world from project launch to closeout. We customize services to each project to meet its unique needs. Contact TRiNDS for more about how TRiNDS can help your project succeed.