Patient Safety is a critical concern for any Life Sciences organisation. Regulatory and Compliance expectations have continued to grow as have the pressures for achieving greater efficiency. In addition, the remit of Safety has expanded making it a critical component in many core processes within Life Sciences companies.
Why Safety Strategy, Process & Organization?
- Aligning pharmacovigilance initiative with over-arching business goals
- Improving effectiveness and efficiency of pharmacovigilance
- Investing in pharmacovigilance systems which conform to regulatory requirements
- Minimize risks to patients and enhance success of clinical trials
How Can Navitas Help?
We have extensive experience and expertise in helping clients develop effective and efficient Safety strategies and operating models. We partner to develop strategy and design & implement the processes, governance and organisation that make it work. We provide solutions and services in the following areas.
- Patient Safety – mapping and driving the transition to a compliant and proactive PV model
- Risk Management – realizing robust and proactive Risk Management processes throughout the business
- Quality & Compliance – engage the broader population in the cost effective delivery of Quality and Compliance
- System evaluation – analyze various safety systems available in the market and recommend the most suitable system
- Harmonization of SOPs – define/refine SOPs that can connect multiple stakeholders involved in the safety process in a seamless manner
- Pharmacovigilance strategy
- Signal detection & risk management strategy
- SOP Harmonization
- Medical authority audit readiness evaluation