MERIT has provided image collection, centralized reading, and data management services for clinical trials since 2012. We partner with CROs as well as pharmaceutical and biotech companies to deliver reliable endpoint services in multi-regional clinical trials.
Our proven track record includes partnerships with 12 of the top 20 global pharma companies. We have supported hundreds of trials across 58 countries. Our clients and partners include Sponsors, CROs, Reading Centers, Imaging Technology Manufacturers, and Clinical Research Sites. MERIT specializes in multiple therapeutic areas including ophthalmology, oncology, respiratory, cardiac safety, neurology, and dermatology. Learn more at https://meritcro.com/
MERIT’s Comprehensive Imaging Services Include:
MEDICAL EXPERTISE. MERIT delivers medical expertise for study design insights such as protocol design and consultation as well as blinded image reads and adjudication.
CLINICAL OPERATIONS. Clinical operations services comprise development of study-specific documents (e.g. Imaging Charters and procedure manuals), site technician and equipment certification, and project and site management.
TECHNOLOGY PLATFORM. MERIT’s comprehensive cloud-based software platform, EXCELSIOR™, built specifically for supporting image data collection and management for clinical trials, offers the latest web and imaging technologies for data standardization, analysis, reading, and reporting.
QUALITY ASSURANCE. Quality Assurance at MERIT forms the cornerstone for our successful management of clinical trial data. MERIT’s QMS is ISO 13485 certified. We prioritize data privacy; we are GDPR compliant in both our processes and software. EXCELSIOR is a 510(k) cleared medical device for ophthalmic and radiological indications that is HIPAA compliant and meets all 21 CFR Part 11 requirements for electronic records and signatures.
MERIT’s Centralized Spirometry Services Include:
SPIROMETRY QC AND READING. MERIT offers centralized review by our Registered Respiratory Therapist (RRT) team using configurable, standardized grading to confirm and adhere to protocol and ATS/ERS standards.
STANDARDIZED EQUIPMENT. We provide uniformly sourced and rigorously tested equipment with study-specific manuals provided to each site.
DATA ACQUISITION AND REVIEW. MERIT’s spirometry data management and configurable software solution enables fast, accurate spirometry data collection in clinical trials.
SITE AND STUDY MANAGEMENT. We provide hands on training for all users with clear instructional materials including manuals, videos, and webinars. Support from our RRTs can be obtained with one simple phone call or email.
Innovative. Proven. Experienced.
Using our innovative and proven technologies and intuitive, seamless workflows, MERIT’s experienced staff bring deep clinical endpoint expertise to ensure the success and integrity of your imaging review studies.
MERIT provides value to clients through over 10 years of experience managing clinical trials. Our dedicated staff delivers decades of therapeutic area expertise. MERIT’s single platform for all study data upload, queries, reporting/tracking, and image transfer and analysis makes managing multi-site global clinical trials not only feasible but practical. Step-by-step imaging protocols, extensive SOPs, and document support from MERIT provide standardized and efficient processes to reduce data variability and risk. Finally, MERIT offers indispensable regulatory support and guidance along with established, time-tested Quality Assurance, security, and data privacy.
If you’re looking for a partner that will bring dedication and expertise to your clinical trial, consider MERIT. Connect with Shinji Yue, VP at MERIT at email@example.com to explore partnership opportunities or learn more about MERIT. https://meritcro.com/