Late Phase/Patient Recruitment for Clinical Research

Over the last ten years PRN has gained comprehensive experience in the management of late phase clinical research – in particular with observational studies and patient registries in the UK and across Europe.

These studies often require a ‘GCP light’ approach for which we have been able to formulate our own template site agreements that have been approved by most of our sponsors as well as many hospitals and clinical research institutions within the EU. We have already tackled areas such as indemnity and the level of SAE collection and can provide you with the benefit of this experience when providing project management for your registry and observational studies.

To ensure the quality of our late phase research we have developed separate working instructions for our late phase team allowing us to work flexibly and therefore faster and more efficiently whilst remaining within a clinical trial framework that is compliant with both local and global regulations.

Additionally, we have now accumulated experience in managing studies in new products which fall into less regulated groups e.g. health supplements and aesthetics.