Medical Servies

Medical Services

The Medical Services team is integral to Cliantha’s success. The services include medical writing, patient narratives, investigators brochures, Medical Monitoring, Safety reporting, Feasibility studies, discussion with KOLs and other documents involving study data.

Cliantha offers a wide array of medical services within the framework of its existing services. Our Medical Services team works seamlessly with all of the Cliantha teams including:

  • Early Phase Investigators,
  • Clinical Trials Management team.
  • Biometrics
  • Bioanalytical
Medical Writing:

Our Medical Writing team follows ICH and other relevant regulatory requirements while conducting their services. Cliantha has conducted more than 5000 clinical studies. The medical writing team is responsible for writing study related documents and is also involved in scientific writing. A brief list of their services is below:

  • Protocol Development
  • Investigator’s Brochure
  • Informed Consent preparation
  • Clinical study report (ICHE3 format, e CTD)
  • Pre IND, IND submission dossiers
  • Biosimilars Clinical development plans
  • 505(b)(2) program development plans
  • Scientific publication
  • Journal articles
  • Manuscript development
Medical Monitoring:

Cliantha Research provides sponsors with a cost effective, experienced group of Medical Monitors. They are available 24 hours a day, 365 days a year and are familiar with clinical research on a global scale. Our team of experienced Medical monitors ensures competent study medical guidance, medical safety and monitoring. Each clinical trial is assigned a medical monitor from the start of the project. The medical executive reviews the protocol, assists the medical writing team, discusses the practical implications with the Investigators, KOLS and ensures the protocol meets regulatory requirements as well as practical issues that are usually faced during execution.

The medical team is involved in training the CRAs on the therapeutic training prior to start of any study.

With a strong medical team in place we ensure that the clinical operations team is supported with a scientific background.

The medical team ensures safety reporting as per the regulatory requirements. Safety reporting includes:

  • SAE case reporting of Initial/Follow up reports
  • MedDRA coding
  • Case narratives
  • Global expedited case reporting
  • Signal detection and evaluation
  • DSUR preparation and submission
  • Reconciliation of SAE

Regulatory Inspections

Last Inspection in Nov 2015
Inspected facility in Nov 2006
Inspected facility in Jan 2009
Last inspection in Apr-May 2016
Inspected facility in Feb - Mar 2013
Last inspection in March 2013
Inspected facility in July 2013
Last inspected by Ministry of Health of Turkey in April 2013
Last inspection in Apr-May 2016