MERIT provides consistent, high-quality independent reading center services to our CRO, pharmaceutical, and biotech partners. Together our work advances and accelerates the improvement of therapeutic options for patients worldwide.
Reading Center
Services
With MERIT’s Reading Center Services, you benefit from the following:
MERIT offers comprehensive Reading Center Services including:
Technology
- Comprehensive Cloud-based Software Platform
- Image upload, evaluation, and QC
Medical Expertise
- Study Design Insights
- Masked Image Read & Adjudication
Clinical Operations
- Development of Study-Specific Documents
- Site Technician and Equipment Certification
- Project Management and Site Support
- Global Reach
Quality Assurance
- Regulatory Compliance
- Data Privacy & Security
Study Design Insights
- Protocol design and consultation
- Reading criteria expertise
- Integration of published reading criteria with protocol and study needs
- Early involvement for protocol/imaging design/clinical data collection
- Advice on clinical endpoints and surrogate endpoints
Masked Image Read & Adjudication
- Uniform image evaluations across clinical sites by masked, independent readers
- Minimize inter/intra-reader variability through rigorous reader training, monitoring and oversight.
- All readers are trained for study-specific reading techniques according to the configuration of the protocol and the expectation of the sponsor.
Development of Study-Specific Documents
- Imaging charters
- Protocol and response-criterion driven, guide all imaging-related activities
- Site imaging manuals
- Provide instructions for sites on imaging schedule, image acquisition & upload, answering queries, site support contact info
- Reading criteria
- Modified and integrated based on protocol need
- Data management documents
- Edit checks, Data Transfer Specification, CDISC standardization
Project and Site Management
- Risk management through anticipating study challenges
- Data quality checks to ensure compliance
- Support ticketing system with <24hr resolution TAT
- Performance reporting
- Regular sponsor/site communications
Site Technician and Equipment Certification
- Detailed user manuals and image acquisition procedures per the protocol
- Investigator Meeting, in-person or remote
- Web 1-1 training and instructions to site technicians
- Site (technician and equipment) certification to ensure readiness for FPI
- Supplemental performance information of a potential site based on prior experience
Global Reach
- Images are collected from different sites around the world, standardized, and stored centrally
- EXCELSIOR delivers seamless image data sharing and evaluation
- Management of sites with different language requirements
- Global regulatory and data privacy compliance
Comprehensive Cloud-based Software Platform EXCELSIORTM
- One validated, secured system that contains all study data: images, tasks, queries, site materials, analysis, and read data
- Cloud-based platform bypasses site IT challenges and effectively manages access rights for sites, sponsors, and readers (zero footprint implementation)
- Eliminates the question: “Where is our data?” and reduces risk of data delays
- 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 Quality Management System (QMS) is ISO 13485 certified
- We prioritize data privacy; MERIT is GDPR compliant in both our processes and with our proprietary EXCELSIOR™ 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 Information Security Management System (ISMS) is ISO 27001 certified
