Highest Drug Safety Standards
The cornerstone of risk management Illingworth Research can provide Pharmacovigilance and Population Viability Risk Management (PVRM) services for all study phases ensuring compliance with the highest current drug safety standards at all times. Pharmacovigilance can also be known as drug safety. It is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Population Viability Risk Management (PVRM) provides a framework for explicitly including qualitative information about the possible outcomes of a management decision.
Activities Can Include:
- Protocol review and PV activities, including subject safety
- Collating, reviewing and reporting Adverse Events (AEs)
- Periodic reporting of collated AEs
- Writing and submitting safety updates to ethical and regulatory authorities
- Expedited reporting of suspected unexpected serious adverse reactions (SUSARs)
- Writing and reviewing PV sections of study reports
- Provide a seamless approach to drug safety for products undergoing both clinical and post-marketing assessments
Safety and Compliance
The provision of pharmacovigilance support in the clinical development stage requires a balance between the need to establish robust compliance programmes for safety monitoring whilst adjusting for the changing nature of clinical development programmes.
Our pharmacovigilance department offers scalable services to meet the demands of the smallest Phase I study, through to complex multi-centre and global clinical trials. The team has experience in trials involving a broad range of indications, and product types including advanced therapies.