Research is subject to a very complex legal and regulatory environment in the UK. All research related activities carried out by commercial and non-commercial organisations that involve the processing of patients’ data are caught in a complex interplay between the pillars of different principles, laws and regulations, including:
From the obligations applicable to the use of identifiable data to those around the process of rendering data contextually anonymised for research purposes, passing through the requirements around transparency, fairness and patient consent, organisations undertaking the role of sponsor or Clinical Research Organisation (CROs) need to be able to navigate through all these principles, laws and regulations to ensure that they comply with their obligations under the law, respect individuals’ privacy, confidentiality and data protection rights, and undertake research in an ethical manner.
We offer comprehensive compliance support to commercial companies, such as pharmaceutical companies or medical device manufacturers, and non-commercial organisations, such as NHS Trusts, academic institutions and charities, whether based in the UK or overseas, that wish to set up research studies.
Our support may include:
At IGS, we can support your organisation to navigate through the legal and regulatory complexities of setting up research studies in the UK. Whether you are acting as a sponsor or as a CRO, we can help ensure that your research study is designed in compliance with the law and in an ethical manner.
We provide a full data protection and information governance consultancy service to all our clients who engage with us. We provide flexible packages and services to make sure that you only pay for what you need, so you aren’t paying for unnecessary services. Whatever you and your organisation need, we are here to help.