Source Documentation & EDC Form Review

Our team reviews source documentation and EDC forms to ensure all assessment-related data is accurately captured and properly documented for regulatory compliance.

Algorithmic Rater & Data Surveillance

CRC’s algorithmic surveillance continuously monitors rater performance, providing real-time feedback to maintain assessment consistency and reduce variability.

Central Ratings

Our central ratings service provides objective, consistent assessments conducted by trained raters. This minimizes site variability and enhances data reliability across the trial.

Protocol Review & Guidance

We begin with a thorough review of study protocols to identify optimal assessment strategies and ensure alignment with study objectives, regulatory standards, and endpoint requirements.

Test Instrument & Endpoint Consultation

Selecting the right instruments and endpoints is essential to meaningful data collection. CRC’s experts guide you through this process, providing consultation on appropriate tools and endpoints that best fit the study’s goals.

Rater Qualification

To ensure high-quality assessments, we qualify raters based on their experience and competence with the selected scales, establishing a reliable foundation for trial consistency.

Rater/Staff Training & Certification

Our individualized, simulation-based training programs equip raters and study staff with the skills necessary to perform assessments accurately and confidently. Certification ensures that all raters meet competence standards, reducing variability and improving data reliability.

FDA Meeting & Hearing Sponsor Support

CRC’s rater services team provides support for FDA meetings and hearings, offering expertise to address assessment-related topics and ensure regulatory alignment.

Scale Licensing & Acquisition

CRC manages the licensing and acquisition of required assessment scales, ensuring all tools are readily available and compliant with study needs.