Services

a3 GCP Consulting

Allan K Johansen, DVM GCP Auditor & Consultant

a3 GCP Training Services

Audits

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.

a3 GCP Consultancy Services

Consultancy

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.

a3 GCP Training services

Training 

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.

What are people saying?

  • I have worked with Allan during the period of 1999 to 2010. Together, we have made significant contribution to build up infrastructure and quality that enables Asia-Pacific to become a top drug development region. Allan 's approach to clinical auditing is more of a coach/trainer and not a policeman and he and his staff are therefore, always welcome at investigational sites. In his work with FERCAP/WHO, Allan is a prime driver in improving the quality of IRBs (Institutional Review Boards) within the Asia-Pacific region. Allan is well respected by institutions as well as pharmaceutical industry within the region and globally.
    Dr. Edmund Tsuei Former Regional Head, Pharma Development Operations, Asia-Pacific-Africa, Roche Pharmaceuticals, worked with Allan at Roche Products Pty limited, Dee Why
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