Through innovative and proven technologies, alongside our intuitive, seamless workflows, MERIT’s experienced staff bring more than a decade of clinical endpoint expertise, ensuring the success and integrity of your clinical trials.
Oncology Therapeutic Expertise
MERIT Team Experience
Our team’s collective Phase I – Phase III experience includes support for:
- 500+ oncology studies worldwide
- 25+ different cancer indications
- 144+ global clinical trial sites
- 1,700+ enrolled patients
These studies utilize a variety of advanced imaging modalities.
MERIT Benefits
MERIT brings value to your studies:
- Technology empowers innovative imaging workflows
- Clinical operations ensure timely deliverables
- Proven & experienced medical experts act as an extension of your team
- QA provides consistent study design & management
Our established workflows reduce risks and costs to complete studies on time by focusing on:
1
Clinical Trial Excellence
- Fast start-up time
- Reduces risk to bottom line
- Flexible & responsive
2
Innovative Single Platform, EXCELSIOR
- One platform for all study data, queries, reporting/tracking, image transfer & analysis
- Easy adoption of technology
- Single system prevents data loss and data inconsistencies
- Cost savings
3
Experienced & Tenured Oncology Team
- Access to readers worldwide in any required specialty
- Global expertise
- Training, routine monitoring, SOP documentation
4
Proven SOPs & Workflows
- Step-by-step Imaging Protocols, SOP and Document Support
- Time-tested protocols and documentation processes
- Processes and workflows are seamlessly controlled and managed by EXCELSIOR
5
Established Regulatory & QA
- Indispensable Quality Assurance, Regulatory Support, and Guidance
- An active partner with sponsors in responding to audits and providing information to regulatory bodies
6
Data Security & Privacy
- MERIT's systems and processes are standardized and ISO 27001 Certified
- We prioritize data privacy; MERIT is GDPR, HGRAC, and Data Privacy Framework compliant
Oncology Team Experience
Staff includes:
- Tenured project managers
- Dedicated imaging specialists
- Meticulous quality assurance staff
- Expert data managers and data quality evaluators
- Adept software developers
- Team has managed 500+ oncology studies across 20+ cancer types
- Our experts have extensive, cumulative experience with RECIST 1.1 and other criteria across all phases of clinical research
- Highly qualified readers, KOLs, and medical advisor team
Our Readers Have Extensive Knowledge & Training
Our board-certified readers are dedicated academic radiologists, world leaders in their respective fields, and can read a large volume of exams in a timely manner
- Participated in 1,600+ clinical trials and contributed to 300+ FDA or EMEA marketing authorization filings
- Trained in RECIST 1.1, iRECIST, mRECIST, Lugano, WHO, RANO, Hallek, PCWG3, Cheson, PERCIST, etc.
- Reading modalities: MRI, CT, PET, SPECT & X-rays
The Power to Manage Imaging Clinical Trials
All-in-One System provides stakeholder access to curated data.
Sponsors can view study progress and data in a transparent, secure environment.
Sponsors can view study progress and data in a transparent, secure environment.
SINGLE SYSTEM – One validated, secure system containing all study data: images, tasks, queries, site materials, analysis, and read data. Read and Adjudication are performed within the system.
UNIVERSAL – One cloud-based platform bypasses site IT challenges and effectively manages access rights for sites, sponsors, and readers (zero footprint implementation).
TRANSPARENT – Eliminates the question: “Where is our data?” and reduces risk and data delays.
TRUSTED – FDA 510(k) Medical Device.
Recent Case Studies Using EXCELSIOR
Team Collective Experience Profile
Collect & Hold Solution
Designed for early phase studies:
- Cost & time savings through prospective collection of study images
- A secure, centralized location for curated images accelerates drug development timelines when central review is needed
- MERIT’s image collection leads to improved image quality & reduced variability among various study sites
Program is an annual subscription-based service that consists of:
- Image collection and quality check, site support
- Project management services
- Project start-up documents (abbreviated imaging charter, site survey, site manuals, project plan)
- MERIT staff to perform image check-in and quality control review
- Centralized storage & access to view the processed radiologic images on the EXCELSIOR platform
- Processed images will be DICOM image files that are stored after the Check- with PHI removed