Many CROs and Sponsors seeking Independent Reading Center (IRC) services for an imaging clinical trial recognize the value of medical expertise and an innovative imaging technology platform. Those aspects are crucial, of course, but they may not be the whole story. You need a partner that not only delivers access to a deep bench of SMEs and a secure, end-to-end imaging platform, but also has the clinical operations experience to drive study milestone achievement. And it all must be based on a robust, foundational quality assurance program. You need the whole package. You need a clinical endpoint expert. Here are the top four reasons to partner with a clinical endpoint expert:
1. MEDICAL EXPERTISE
Study Design Insights. The medical expertise brought by a clinical endpoint expert delivers everything from protocol design insights, to reading criteria expertise, to integration of published reading criteria with protocol and study needs. A team of medical experts can also offer advice on clinical endpoints and surrogate endpoints. The early involvement of SMEs in the design of your protocol, imaging procedures, and clinical data collection process can greatly enhance the success of your study.
masked Image Read & Adjudication. Uniform image evaluations across clinical sites by masked, independent readers are at the core of independent reading center services. Masked centralized reads can minimize inter/intra-reader variability through rigorous reader training, monitoring, and oversight. All readers must be trained for study-specific reading techniques according to the configuration of the protocol and the expectation of the sponsor.
2. TECHNOLOGY PLATFORM
Comprehensive Cloud-based Software Platform. A clinical endpoint expert should provide one validated, secured system that contains all study data: images, tasks, queries, site materials, analysis, and read data. A cloud-based platform has the benefit of bypassing site IT challenges and effectively managing access rights for sites, sponsors, and readers (zero footprint implementation). A single system platform eliminates the question: “Where is our data?” and reduces risk of data delays.
Image Acquisition, Upload, and QC. Efficient, accurate acquisition and upload of images depends on the clinical endpoint expert’s technology platform. Images should be directly transferred from qualified sites to a central database, so that no installation of software or configuring of firewalls is required. The technology platform must empower immediate QC, with quick confirmation that images have been acquired correctly, are de-identified, and contain no PHI. This ensures all images are ready for masked read. Prompt feedback to the site through an integrated query system prevents further images from being acquired incorrectly.
3. CLINICAL OPERATIONS
Development of Study-Specific Documents. The clinical operations team’s development of imaging charters is a vital service. Charters are protocol and response-criterion driven and guide all imaging-related activities for a study. Site imaging manuals are also important and provide instructions for sites on imaging schedule, image acquisition and upload, answering queries, and site support contact information. Data management documents developed by clinical operations include edit checks, the Data Transfer Specification, and possibly CDISC standardization.
Project and Site Management. Clinical operations’ project and site management services deliver risk management through anticipating study challenges. Clinical operations provides data quality checks to ensure compliance with study documents. A support ticketing system with <24hr resolution TAT ensures issues are addressed swiftly. Performance reporting and regular sponsor/site communications are crucial services provided by clinical operations.
Site Technician and Equipment Certification. The site technician and equipment certification provided by clinical operations ensures the readiness of sites for study start up. The process should include detailed software user manuals and image acquisition procedures per the protocol. Clinical operations can offer supplemental performance information of a potential site based on prior experience.
4. QUALITY ASSURANCE
Regulatory Compliance, Data Privacy & Security. Quality Assurance must form the cornerstone for a clinical endpoint expert’s successful management of clinical trial data. Their Quality Management System (QMS) should be ISO 13485 certified, and they should have experience with regulatory agency inspection and vendor auditing by sponsor companies. They must prioritize data privacy and be GDPR compliant in both processes and software. Their technology platform needs to be HIPAA compliant and meet all 21 CFR Part 11 requirements for electronic records and signatures.
MERIT SOLUTIONS
MERIT is a global clinical trial endpoint expert and recognized leader in medical imaging. We partner with CROs, pharmaceutical, and biotech companies to deliver reliable IRC services in clinical trials. Together our work advances and accelerates the improvement of therapeutic options for patients worldwide.
Partnerships with MERIT provide the following advantages:
- Expertise in managing and evaluating images
- Standardization of data, readers, and interpretation
- EXCELSIORTM technology platform for stakeholders to work together with data transparency and accessibility
- Collaborative approach with nimble and attentive service for Sponsors
Learn more about our services here