Services
Protocol Guidance - Rater Training - Support - eCOA
Guidance
A Comprehensive Approach
We provide guidance on formulating a standardized training protocol, manual of operations, and study resource documentation to ensure a uniform, consistent process of testing and data collection. We provide:
Guidance on outcome measure selection
Formulation of standardized training procedures, manual of operations, and study resource documentation to ensure a uniform, consistent process of testing and data collection.
Advise on training equipment and needs for individual sites to ensure a standardized protocol while keeping the practicality of testing in mind
Creation of an abridged training resource for quick reference for in-study support
Guidance in the development of a training video (script, protocol adherence, quality assurance, content, etc.) that outlines the study’s testing protocol as a supplemental resource as needed
Rater Training
Expert Instruction
We utilize Physical Therapists who are educated, knowledgeable, and experienced in the use of clinical outcome assessments to train, evaluate, and certify each clinical evaluator individually. Our training methods highlight study specifics to ensure the most accurate grading of the outcome assessment. Our training includes:
Didactic and practical hands-on training recognizing each individual’s style of learning to maximize the evaluator’s ability to accurately and consistently perform the outcome assessments
Applied skills assessments and in-person or remote web-based training/re-training and certification for sites as needed to ensure standard administration of sponsor protocol
Certification for each CE trainer that has adequately demonstrated skills to implement testing
Site initiation visits (SIV) and Investigator Meeting (IM) Training/Certification
Support
The Path to Success
We continue to be accessible as a remote resource for clinical evaluators for questions or guidance throughout the study. We provide:
Live or remote re-training of clinical evaluators
Tracking of re-certification requirements throughout the duration of the study
eCOA
Electronic Clinical Outcome Assessment
Rater Training and Support - Anytime, Anywhere
We are experienced in the technology and procedure to remotely assess patients, train CEs, or provide feedback of recorded assessments resulting in more granular endpoint data. We offer:
Quality control of outcome assessment data via video review of in-clinic assessments to ensure proper compliance with standardized testing practices
Remote assessment of clinical evaluators’ ability to perform the clinical testing to ensure a standardized testing environment and adherence to protocol
Remote assessment of patients