Real Time Trials' highest priority is to detect and successfully manage safety issues that may arise after the drug being licensed and thus to effectively protect its position in the market.
Real Time Trials' personnel has an extra-ordinary hands-on knowledge about FDA, EMA and the local EU Competent Authorities. Last changes of regulatory requirements mean that there has never been a more critical time to have the highest possible standards in drug safety available to your company and your products than now.
Real Time Trials can come up with a pharmacovigilance service tailored to your specific needs: from individual case management through to providing your an entire pharmacovigilance department (in-house or externally).
Our services include:
Design, implementation and delivery of a global, regulatory conform pharmacovigilance system, well documented and supported by SOPs;
Management of ICSRs from all sources;
ICSR receipt, data entry, triage, MedDRA coding, narrative writing, medical review, quality control and reporting of cases to agencies;
Provision of a central telephone “hot-line” and e-fax capability;
Literature analysis and review;
Registration of your company with EudraVigilance Post-authorisation module;
Provision of the European qualified person for pharmacovigilance (QPPV) and deputy with comprehensive 24-hour on-call facilities;
Signal generation, detection and trend analysis;
Preparation and submission of PSURs (EU) and PADERs (U.S.);
Elaboration of risk management plans (RMPs);
Design and implementation of risk mitigation activities; e.g. PASS and patient registries;
Benefit/risk ratio evaluation and management of potential safety issues;
Managing interactions with third-party organisations, CAs and commercial partners;
Representation in and negotiation with regulatory authorities;
Preparation for a CA pharmacovigilance inspection;
Auditing of PV systems, including pre-inspection control and evaluation.