For many studies, Trial-CARE can provide complete clinical trial coordination services as a Coordinating Center or Academic Research Organization (ARO) for multi-center clinical research trials. This typically would involve a study-specific partnership plan developed in collaboration with the investigator, whereby Trial-CARE provides coordination services tailored to the individual needs of the study and existing research team.

Example services related to Clinical Coordinating Center activities include:

Project management
  • To include overall project management and Coordinating Center activities
  • Manage network of clinical trial performance sites
  • Oversight of core laboratory activities
  • Organize/manage content for investigator meeting(s)
  • Organize meetings and calls with committees, sites, partners
Protocol development
  • Assistance with multicenter trial-specific protocol development and amendments
  • Develop study manual of procedures and standard operating procedures, with key insights specific to multicenter trial management
Regulatory authority submissions
  • Oversight and management of Central IRB submissions, responses, and updates across sites
  • Oversight of Investigational Device/Investigational Drug accountability across sites
  • Assistance with FDA submissions, responses, and safety updates
Site recruitment, initiation, management
  • Management of site communication required for general study conduct
  • Management of study start-up process, including collection of essential regulatory documents and site/investigator credentials, facilitation of sub-contracting process, IRB submission and document collection, and conduct of site initiation visits and site training
  • Tracking and execution of milestone payments to sites
  • Develop plan for risk-based site monitoring and conduct in person or remote site-monitoring visits with appropriate follow-up
  • Conduct site close-out activities
Safety event monitoring
  • Guidance on selecting a Safety Officer/Medical Monitor
  • Develop eCRFs that include AE/SAE/UADE/UP capture and ensure EDC includes an online interface for sites to submit events and associated source documentation
  • Depending on the EDC platform, program and execute notification to CCC team to ensure timely reporting of events from all performance sites
  • Assist with initial review of events reporting by sites and conduct data verification as needed
  • Track safety events across all sites, complete expedited reporting as needed, and ensure ongoing SAE file maintenance
  • Prepare and submit FDA safety reports

In addition, depending on sponsor expectations and platforms to be used for data management, Trial-CARE can collaborate with research teams and other institutional partners to form Data Coordinating Centers (DCCs) for selected studies.

Example services related to Data Coordinating Center activities can include:

  • Support study teams in developing case report forms (CRFs) and building electronic data capture (EDC) system for efficient data capture across multiple performance sites
  • Conduct training and provide user access to study personnel
  • Manage data verification, query generation, and resolution across all sites
  • Provide overall data quality and protocol compliance monitoring across all performance sites
  • Provide oversight and management of the DSMB and associated activities, including set-up, executive secretary services, and data reporting
  • Collaborate with study biostatisticians and trial methodologists
  • Part-11 Compliant Trial Services

Please contact us for additional information or to request a consultation