Determining drug safety

The benefits of a medicine must be weighed against its side effects and the acceptable level of risk decided upon by the organisation developing the therapy, by the regulators who approve it for clinical development, and ultimately by healthcare professionals in consultation with their patients.

Our pharmacovigilance services monitor and assess the possible risks of medicine in development, with a core focus on drug safety. Through pharmacovigilance clinical trials, clinical safety data are collected, and continuously evaluated throughout the clinical development process. These data are used to assess and monitor the incidence of adverse drug reactions (ADRs) so they can be fully understood, and any necessary adjustments made to dosing advice, contraindications etc. 

Devising a risk management plan

A Risk Management Plan (RMP) should focus on the most important safety concerns, thereby prioritising the issues which are likely to have the greatest impact on patients. Effective Risk Management Planning is collaborative and requires input from multiple stakeholders.

Pharmacovigilance Services

Simbec-Orion’s highly qualified team of pharmacovigilance experts, drawn from clinical research organisations (CROs) and across the pharmaceutical industry, collaborate with your teams to ensure you have the most appropriate pharmacovigilance, product surveillance and drug safety support for your needs. We have the facilities, technology and expertise to offer full-service pharmacovigilance solutions, our end-to-end case processing includes: 

  • Triage
  • Medical triage
  • Data Entry
  • Quality Review
  • Medical Review
  • Approval
  • Submission
  • Reconciliation (internally and with third parties)

Project & System Management

  • Safety database hosting on Aris Global LifeSphere Safety MultiVigilance (LSSMV), a system that is 21 CRF part 11 and E2B R3 compliant. The system allows the accurate processing of cases for signal detection, aggregate report generation, and statutory electronic reporting to regulatory authorities.
  • EudraVigilance Substance, Product, Organisation and Referential (SPOR) User registration and Responsible Person (RP)
  • Extended Eudravigilance Medicinal product registration (xEVMPD) registration and regulatory intelligence monitoring
  • Safety data migration
  • Development of the pharmacovigilance system master file (PSMF)
  • Safety Data Exchange Agreements (SDEA) authoring/management
  • Quality system and Standard Operating Procedures (SOPs)
  • Audits and Inspections services

Supporting you at every stage

Our pharmacovigilance team works with you to ensure your products are compliant with the latest EU & FDA regulations at every stage of your product development lifecycle; from FiH, through clinical development and pre/post marketing. At Simbec-Orion we provide best-in-class comprehensive PV services and high standard quality processes using our technologies, partnering with pharmaceutical companies to ensure patient safety.

Research & Development

Aggregate report writing (Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR) and Periodic Adverse Drug Experience Report (PADER))

  • Development of Risk Management Plans (RMPs)
  • Pharmacovigilance signal detection, evaluation, and validation
  • Qualitative Signal detection and case processing
  • Literature search and review
  • Unblinding services for regulatory reporting (unblinding in clinical trials)
  • Translational services

Post Marketing Pharmacovigilance

  • Our clinical trial and post-marketing Pharmacovigilance reporting capabilities are backed by our regulatory intelligence, for both individual expedited reporting and aggregate report submissions to regulatory Authorities, Ethics committees /institutional review boards and investigators.
  • ICSR Management: Clinical trial and post-marketing case processing

Expert Pharmacovigilance Team & Partnering Companies

  • Communication with Regulatory Authorities
  • European Economic Area (EEA) Qualified Persons for Pharmacovigilance (QPPV)
  • Clinical trial safety committee management to fulfil clinical endpoint committee (CEC) and data safety monitoring board (DSMB) requirements.

Let’s collaborate

If you think we could be right for you, get in touch.

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