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
  • Preparation of the investigator’s file,
  • Preparation of the monitoring visit forms,
  • Site selection, initiation, periodic and close-out monitoring visits,
  • Monthly reports to the sponsor company,
  • Reporting to the sponsor company after every monitoring visit,
  • Apart from the monitoring, contacting with the sites and collecting information about the number of patients, adverse event submissions, supply/device requirements and other issues and transmitting them to the sponsor company,
  • Preparation of the Annual Notification and Study Final Reports,
  • Serious Adverse Event notifications

In case of need, the below organization services can also be provided:
Performing feasibility activities and preparation of feasibility reports as follows:

  • Performing feasibility activities and preparation of feasibility reports as follows:
  • (Cooperating with the sponsor company for the selection of the Clinical Reseach Associates who can work in compliance with the GCP regulations,
  • Providing information on Ethics Committee procedures and recommendations,
  • Providing information on the patient population and the efficiency of the sites that are planned to be included in the studies,
  • Investigation of the viability of the central laboratory, imaging centers organization and sample abroad delivery services.
  • Feasibility Assessment for Site Selection:
  • 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

Organization and process management of institution or private examination centers, providing sample transfers in all clinical project including domestic and foreign delivery;

Organizations and purchasing of all third party payments and delivery, accounting records

Import licence and customs procedure follow up

Organization of patient support and patient transfer procedures

Site coordinator/study nurse/data entry support designee support service ( employment, management, payment organization) as follows:

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

Hiring clinical research associate

Employment of clinical trial assistant

Site management

Investigator Meeting Planning and Coordination

Site Specific File Management

Clinical research documentation (storage of completed study materials)

Storage and destruction procedures of clinical research returned materials

The Best Outsourcing Solution!

Full service CRO with Customer-Oriented project management and proposals

Excellent expertise with more than 350 completed projects.

High level of customer satisfaction with dedicated team work and synergy.

Clear strategies for your projects starting from the beginning.

Project and staff stability.

Quick start-up timelines with good communication to the ECs and RA.

Flexible, proactive, professional teamwork.

Competitive costs, Efficient processes

Open communication to our clients and employees

Good risk mitigation processes and planned business continuinity

Quality Certificates such as MoH GCP Certificate, ISO:27001 Information Security Management.

Micromanagement on project and site performence.

High patient recruitment level and efficient patient retention policies.

Recruitment strategies for targeted populations.