Clinical & Market Research Regulatory Requirements
Through our partnership with Wendy Fisher Consulting (WFC) who specialise in regulatory affairs, we assist you in meeting your required clinical and market research regulatory requirements promptly and with the minimum of difficulty.
Is it medical or market research?
Healthcare research and healthcare market research studies are often locally defined resulting in the need to understand the difference between the two approaches in terms of research regulatory requirements.
At Health Outcomes Insights we provide pre-project practical advice to the client as to whether there is a need to secure required regulatory and ethical approval or not for clinical and market research -Ethics Review Boards. Where there is such a need our consultants will provide expert advice on the regulatory requirements for clinical research in the UK and internationally and assist you to develop your research proposal into a full protocol with associated documentation ready for regulatory review. When working with us a WFC consultant will become your ‘caseworker’ and look after your entire application, initiation of sites and set-up, ensuring a streamlined process.
Our services include:
- Protocol and documentation development
- Regulatory affairs and submissions
- Monitoring and compliance
- Quality assurance (QA) work-stream projects