International Good Clinical Practice Requirements
Advice on the international GCP requirements for conducting clinical research can be provided. Guidance can be given on common areas of GCP non-compliance and solutions provided to resolve these deficiencies.
SOP Development and Review
A comprehensive set of SOPs is key to the conduct of clinical research to GCP standards. Advice can be provided on SOP development both in clinical research and quality assurance. SOP development is tailored to the requirements of the company after discussions with the client.
The review of SOPs is undertaken to ensure they fulfil the regulatory requirements and that they are an accurate reflection of the procedures for which they are intended. They should provide information on how and what is required to perform a task. Personnel responsible for undertaking specific tasks should be well defined. The activities should be clear and have a logical and pragmatic order.