Drug Safety/Pharmacovigilance

Drug Safety monitoring or Pharmacovigilance has long been fundamental to the industry, but more thorough safety documentation and reviews for drug approvals by regulatory agencies, and increased warnings and awareness about adverse drug reactions, have made drug safety one of the top issues for industry, healthcare professionals, consumers and regulators. The amount and variety of safety-relevant data gathered from different patient populations in global clinical trials are enormous; therefore, it is crucial that a concise and systematic approach to pharmacovigilance be implemented. Systematic safety monitoring is needed to identify previously recognized and unrecognized adverse drug reactions and to evaluate the safety and efficacy of medicinal products during clinical trials and in the postmarketing period.

DDReg has developed efficient processes for the drug safety/Pharmacovigilance management which have been proven helpful for its clients in maintaining the compliance in markets like US, EU, CIS GCC.

In order to carry out the safety processing DDReg uses safety database(PcVmanager by Extedo) that is E2B(R3) compliant and Validated to comply 21CFR part 11, has Full Gateway functionality, is flexible with intuitive user interface and has multi tenancy that works efficiently with multiple MedDRA versions and has Full data XML file import and export functionalities.

Our services in this area include

  • Case Processing and Reporting - Data entry and quality checks as per E2B requiremeCase Processing and Reporting-Data entry and quality checks as per E2B requirements,MedDRA Coding,Narrative Writing,Medical Coding and Follow Ups,Submission through Electronic Submission Gatewaynts, MedDRA Coding, Narrative Writing, Medical Coding and Follow Ups, Submission through Electronic Submission Gateway.
  • Safety Writing Submission – Authoring and compilation of-Aggregate Reports – PADERs, /PBRERs/PSURs,Annual Safety Reports,eSubmission of PADERs
  • Risk Management-Risk Evaluation and Mitigation Strategy (REMS)/ Risk Management Plans,Signal Detection, evaluation and Reporting
  • Literature Search - Worldwide Scientific Literature search from PubMED and EMBASE
  • Drug Safety System Set Up - Development of Standard Operating Procedures (SoPs) and Working Guidelines(WGs),Process Flows and reporting templates,Safety Data Exchange Agreements,Trainings on SOPs/WGs, Regulations and Stakeholder Obligations

Other Services

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