Drug Safety and Pharmacovigilance

Patient safety is the main priority of any clinical study. Since 2005, the number of patients recruited by OCT is in excess of 50,000. We take a serious approach to implementing and following the principles of patient orientation at every stage of the study. Our team performs all pharmacological supervision tasks and preparation of safety reports within the framework of clinical trials, and we ensure that all security information is collected and communicated to all parties involved in a timely manner.

Study safety is guaranteed in the following ways:

  • Establishment of pharmacovigilance processes and procedures;
  • Safety data assessments;
  • Obtaining data on serious adverse events, as well as describing and processing them;
  • Data entry and coding by MedDRA;
  • Medical assessment and quality control;
  • Informing regulatory authorities and research sites about suspected unforeseen serious adverse reactions;
  • Preparation and submission of safety reports to regulatory authorities in all countries involved in the study;
  • Preparation and submission of an annual safety report to research sites.

Based on extensive experience in the field of pharmacovigilance and a deep understanding of regulatory aspects, OCT specialists prepare high-quality safety reports within specified time frames.

Send an RFP
Thanks! Your message has been sent successfully!
An error has occurred. Try sending the message again or contact us in another way.