Services offered cover all aspects of Good Clinical Practice and are customised to meet each individual client’s needs and can include:
Investigator site audits
Review of both in-house and on-site documentation to assure compliance with ICH GCP and all appropriate regulations
Phase I audits
Full facility audits of Phase I units to assure compliance with the appropriate guidelines and regulations prior to placement of study.
Live phase audits to assess all protocol requirements are followed
Preparation for Regulatory Inspections
Regulatory authorities are now carrying out inspections in accordance with the Clinical Trial Directive 2001/20/EC. Full mock inspections can be carried out or advice and training of staff provided.
To provide assurance that all data procedures have been carried out and that the database is a true reflection of data captured on CRFs.
Clinical Report Audits
To provide assurance that the clinical study report accurately reports the conduct and results of the study and that the format complies with ICH GCP.
Clinical Laboratory Audits
Audits of central clinical laboratories to give assurance that they are working to Good Clinical Laboratory Practice standards.
Assessment audits of CROs
Independent audits of CROs prior to contract placement to give assurance that the organisation is fully compliant with ICH GCP and able to provide the service required.
Individually designed courses to update clinical research personnel on GCP requirements. Training in auditing skills for new auditors.
Preparation of Standard Operating Procedures
Advice and preparation of SOPs to assure compliance with GCP requirements.
Support and Advice
Additional support for QA units to meet short term needs at times of overloading. Advice on general issues relating to GCP.