Clinical Management Trial

People Walking on Clock

Clinical Trial Management

The main services provided in terms of Clinical Trial Management in Klinar CRO are as follows:

 

Monitoring and Project Management:

 

For each trial a dedicated team composed of experienced Project Managers and CRAs is assigned to conduct the study according to ICH/GCP, local regulations and SOPs. The following services are provided by Klinar CRO in project management field:

 

  • Monitoring visits compliant with sponsor requests
  • Rapid information flow, including significant monitoring findings
  • Detailed monitoring visit reports in a timely manner
  • Regular site contacts to track site needs, AE reporting and query resolution
  • Tracking trial site status via electronic follow-up system
  • Organization for and attendance to site audits that can be performed by sponsor and regulatory authorities
  • Close follow-up of study sites in terms of patient recruitment and retention

 

Site Management Organization:

Klinar CRO provides site coordination service either by its own staff or by organization of study nurses. The scope of this service is to provide study nurses, coordinators for supporting the sites in terms of;

 

  • CRF completion,
  • Laboratory procedures,
  • Investigator file updating, etc. upon request of sponsor or investigator
  • Job description and visit frequency can be determined by sponsor and investigators

 

Post-marketing Surveillance Studies:

 

Two different methods are applied for these trials:

 

  • Remote monitoring (Data collected by the sponsor company is forwarded to Klinar CRO for data entry and analysis. Data query forms are prepared by Klinar CRO to resolve inconsistent and/or incomplete data)
  • Direct monitoring (All data collected and analyzed by Klinar CRO
  • For both of the above methods, Klinar CRO ensures that EC approval process is completed.
  • Feasibility Assessment for Site Selection:
  • Feasibility assessments of trials are performed on behalf of the sponsor company;
  • Decision on potential study sites by using detailed investigator database structured over 150 studies.
  • Preparation of feasibility questionnaires based on study protocol is organized
  • Evaluation of sites based on completed questionnaires via feasibility reports are done