Independent GCP audits - on behalf of clients / sponsors or QA partners - conducted according the protocol, ICH GCP and local / international guidelines and regulations (including FDA, TGA, and EU standards) in the areas of:
- Investigator Sites – phases II to IV
- CPUs (Clinical Pharmacology Units) – Phase I healthy volunteer studies incl. FTIH. & phase I patient studies
- Service Providers – Contract Research Organizations (CROs) including full service, Archiving Facilities, IRBs/IECs/HRECs
- Clinical Laboratories – central or local hospital labs processing samples from clinical trials
- Pharmacovigilance – sponsor’s local affiliate safety departments
- Study Management – sponsor study management / clinical operation departments, including GCP ‘Gap Analysis’ audits
- Pre-inspection visits – prepare sites for forthcoming Regulatory Inspections eg FDA or EMA
- Essential Documents – e.g. Clinical Study Reports (CSRs)
Audits can be conducted as pre-selection evaluation, pre-contract (‘qualification’), or in-process activities, as well as ‘directed’ / ‘for cause’, the latter in case of suspected misconduct/ serious non-compliance issues or fraud.
Whenever practical the ‘root-cause’ method is used by drilling down the ‘why’ – why did this happen? - with focus on the systems, and not the personnel. When requested, follow-up of CAPA submitted as answer to audit findings is also offered, as well as issuing of Audit Certificates.
Before study start: QA review of the Investigator’s Brochure (IB); study Protocol; Patient Information Sheet & Form; Study Monitoring & Management Plan, Ethics submissions, Investigator CVs, FDA Form 1572 (where applicable) etc.
At study completion: review of ‘Essential Documents’ for compliance with ICH GCP and sponsor SOPs.
Ongoing: input to the development to and review of clinical Quality Risk Management Systems including QM Plan, Policies, and SOPs with supporting documents (forms, templates, checklists etc).
Any time: clarifications or suggested solutions for urgent GCP compliance issues or ‘grey’ GCP areas.
Customised in-house GCP training of sponsor / CRO clinical staff, and investigator site staff in conducting studies in compliance with the protocol, GCP and local regulations, focusing on the responsibilities and tasks of each individual role and drawing on experience from a vast audit ‘portfolio’ in the country/region in question.
Presentation of the ‘token’ GCP session at Investigator Meetings including Monitor & Study Coordinator’s Workshop, with focus on the sections of ICH GCP relevant to the audience (Investigators, Study Coordinators, and Monitors, respectively), and most important providing the WHY – ‘why’ there are these particular requirements according to the GCP.