Your CRO of choice for neurology
PRIMARY ENDPOINTS AND
As CNS trials are highly reliant upon subjective endpoints, the choice of suitable psychometric instruments is essential to demonstrate efficacy. Our staff can advise in the selection of appropriate, well-defined and guideline-conforming tools appropriate for the use in clinical trials. These measures and their changes over time are coupled with support in standardisation and rater-trainings to ensure consistency and evaluable data. Most trial patients find it cumbersome to record health-related information using paper diaries, especially when the instruments require observer information. Therefore, technology driven data collection models for patient data collection, including handheld devices such as tablets, smartphone apps downloaded on patients’ phones, and electronic Patient Reported Outcome (e-PRO) instruments are a major consideration for a successful study set-up, and reduce the burden for patients. SCOPE works with selected providers for electronic Clinical Outcome Assessments (eCOA). Our monitors assist study coordinators in training patients to complete self-rated scales, ensuring timely capture and review of responses captured through patient diary data. Our trained project managers identify and mitigate study risks from the outset, while our site communications continually focus upon training, assessment, and feedback to ensure quality and consistency across all participating centers.