Our clinical operations team provides personalized attention, collaborating closely with our partners to focus on details that drive study milestone achievement and increase site engagement.
Clinical Operations
DEVELOPMENT OF STUDY-SPECIFIC DOCUMENTS
The clinical operations team’s development of study-specific documents is a vital service. This includes:
- 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 & SITE MANAGEMENT
Clinical operations’ project and site management team deliver risk management through anticipating study challenges. These services include:
- 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
SITE TECHNICIAN & EQUIPMENT CERTIFICATION
The site technician and equipment certification provided by clinical operations ensures the readiness of sites for study start up.
- 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
We conduct studies across the globe with experience managing clinical sites in 63 countries.
- 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
MERIT’s clinical operations team delivers dedication and expertise for your clinical trial.