Pharmacovigilance is becoming ever more critical for pharmaceutical companies as the public and legislative pressure to ensure drug safety increases every day. Effective and regulatory compliant implementation of pharmacovigilance will aid drug development, benefit rational communication and sound public understanding. The challenge to manage drug related adverse events in an optimal and efficient way and, at the same time, adhere to regulatory requirements will demand a great emphasis on pharmacovigilance in the near future, and this is the reason why Accelsiors safety team is monitoring so closely the latest developments and strategies in this field. We offer up-to-date, sound and integrated services to help you develop and implement safety and surveillance programs for your products in development. We routinely collaborate with pharmaceutical and biotech companies, generic drug manufacturers and device companies to providePharmacovigilance Services, Medical Monitoring, Medical Writing, Medical Consulting and Trainings.
We offer the following consultancy services, beyond the development of robust pharmacovigilance program:
- We will help you to assess the Benefit/Risk Ratios of your products to strike the right balance
- We will help you in identifying and handling of challenges associated with rare disease pre and post-marketing surveillance efforts
- We will guide you to develop a unique risk management framework around your medicinal products for the treatment of rare or orphan diseases
- We will keep you updated on the latest regulatory developments within the area of orphan pharmacovigilance
- We will pay particular attention to maximallyunderstand adverse event information obtained from minimal patient exposure – which is particularly important in pediatric populations
- We will advise you how to best build a robust PV system in a small organization
- We will help you in safety signal detection and risk management during development of your medicines
- We will offer you the best quantitative methods that could be applied to safety databases to detect potential safety signals
- We will be advising you how to develop the best risk mitigation strategies that are vital for drug safety and surveillance
- Analyzing your existing system we will advise you how to improve it bringing to you latest insights, integrated strategies and best practices in pharmacovigilance
- We will be developing and implementing training programs for your pharmacovigilance systems, bridginggeographies and requirements
- We will be developing for you the Developmental Safety Update Report harmonizing periodic safety reporting of your ongoing clinical trials
- We will support and guide you in implementing inspection readiness program(s)in order to maximize your readiness
- We may help you in your internal Drug safety investigation – Pre and Post Marketing
- We will help you to establish the most effective Data Monitoring Committees and will support work of these committees
- We will ensure you are compliant with applicable regulations in pharmacovigilance
