Service
Conreso Call-Center

The Call Center is a special service which enables a safety follow-up, and respectively supplements or ensures the documentations from the trial centers.

To accomplish this, the clinical trial participants are contacted by carefully trained medical students who question them in a protocol-specific manner in regard to any reactions/medical events which they may have experienced.

The Call Center agents are not subject to any directives from Conreso or the sponsor as to the content of the data documentation.

This procedure guarantees superior safety data.
  


Pharmakovigilance

In cooperation with their joint venture HCTC, Conreso provides professional and comprehensive pharmacovigilance services:

 
  • Evaluation of ADRs in clinical trials
  • Electronic reporting according to ICH-E2B
  • Annual Safety Reports (ASRs)
  • Periodic Safety Update Reports (PSURs)
  • Data Safety Monitoring Boards (DSMBs)
  • Qualified person for pharmacovigilance according to AMG § 63 a (1) [German Medicines Act]