Clinical Operations

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.

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 58 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.

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YOUR PROJECT

Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget. Your success is our priority.