Kinapse, a Syneos Health® company, provides a comprehensive safety and pharmacovigilance service, drawing on more than 27 years of clinical safety experience and 15 years of post authorisation pharmacovigilance.
Your partner in patient safety
“Our team of PV experts partner with the world’s leading Life Sciences companies and regulatory agencies to establish global strategy and run operations to improve patient outcomes. In an era when public confidence in the pharmaceutical sector needs boosting, safety is at the top of Europe’s legislative agenda. Kinapse is uniquely positioned through our long term partnership with the European Medicines Agency and with extensive experience with US, Canadian, Japanese and EU Regulators to implement global PV requirements and support enhanced public health.”
Stuart Donald – Head of Operational Services
Full list of pharmacovigilance services
Post Authorisation Pharmacovigilance
- Pharmacovigilance System Management
- Risk Management Plans (RMP)
- Safety Report Writing (PSUR/PBRER, PADER)
- Literature Services
- Signal Detection
- Adverse Event Processing and Expedited Submissions
- Independent Quality Control
- Safety Call Centre
Clinical Trial Drug Safety
- Case Processing and Submissions
- Safety Data Report Writing (DSUR)
- Substance, Product, Organisation and Referential (SPOR)
- Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
Kinapse offers scalable bespoke and full lifecycle pharmacovigilance services. We bring the advantages of a small company culture but with a large organisation’s capabilities and scale. We are uniquely placed to be a flexible and capable partner for all of your pharmacovigilance needs.
We provide a high level of expertise, coupled with an open and respectful culture, which enables us to work as a trusted extension of your team. This approach frees up your in-house staff to help you make quicker and safer decisions.
We understand that accurate safety assessments and high quality are of paramount importance, both to protect patient safety and ensure audit readiness at all times. Our services are underpinned by a robust pharmacovigilance quality framework, which enables us to help our client’s meet regulatory requirements and ensure continuous audit readiness.
We currently support pharmacovigilance for a wide variety of clients; from top 20 pharmaceutical companies to small single product companies, as well as other industry partners. Our clients acknowledge our quality and dependability by continuing to work with us year after year. We have partnerships spanning over 10 years and in some cases, we are the sole providers working extensively as their safety partner of choice. Our clients also value our proactive and collaborative approach to drive continuous improvement and efficiency.
Our successes with key strategic pharmacovigilance programmes have been achieved by:
Having experienced staff with strong internal oversight and governance, allowing our clients to focus on the activities that are important to them
Ensuring our processes are tailored to each client, minimising client effort while maximising quality and timely delivery
Ensuring delivery to specification is managed through data-driven performance assessment and well defined and measurable key performance indicators
Assurance of quality. We pride ourselves in delivering high quality outputs and these are achieved through a robust internal quality control and medical review process as well as optimising the process when the time demands
Ensuring critical requests such as those from Health Authorities are given the urgency which they demand and are dealt with in an expedited manner
Always understanding whether there is potential for process optimisation and working with our clients to achieve continuous improvement
State of the art report trackers and tools to guide the teams for action oriented decisions and developing best practices