Overview

From First in Man and Proof of Concept to Phase IV post-marketing studies, and everything in between, IMETICS provides a broad range of global facilities and therapeutic expertise to meet your clinical trial needs. Within our organisation we have the experience and local presence to help you succeed regardles of the sides or scope of your project.

Let us manage the complete clinical trial process, including planning, patient and investigator recruitment, data management, biostatistics, clinical pharmacology, regulatory compliance, and much more.

IMETICS is currently conducting and participating in local and international clinical trials in Romania, Western and Eastern Europe. We interact with a network of non-clinical and clinical research sites and resources with experienced Investigators in a broad range of therapeutic categories.

Clinical Project Management

 All aspects of trial design, conduct and reporting are handled in agreement with the Sponsor

Trials are managed according to ICH-GCP guidelines

Project Management is based on an electronic planning and management tool

Recruitment rates and detailed progress reports are frequently provided to the Sponsor

One Clinical Project Manager (CPM) is responsible for all aspects of the trial and is the primary contact person for the Sponsor

The Clinical Project Manager is supported by Clinical Research Associates (CRAs) and Clinical Trial Administrators (CTAs)

Clinical Trial Monitoring

 CRAs have a University degree in Science, Pharmacy or Medicine. They are accurately trained in GCP/ICH, Company and Sponsor SOPs

Clinical Trial Monitoring activities consist of: Trial set-up, monitoring and close out activities

Investigator Meeting participation

Source Document Verification

Adverse Event management