Quality, audit and training

Audit

No human being is free of human error…

No clinical trial is free of quality issues…

Qualtiy issues are unavoidable, maybe inevitable during the course of a clinical trial. What is important is that we address them promptly and properly in order to prevent them from happening again. Clinical trials with poor quality will jeopardize the whole development of a new product and its application for marketing approval.

Independent audit as required by GCP is an effective way to confirm the quality of a clinical trial conduct and data.  PharmaGCP offers highly efficient and cost-effective audit, as our audit team consists of 2 members; a competent auditor and a clinical QA manager. The advantages of this approach is that the audit is conducted effectively –  good flow – limited waiting/available time by the audittees and practical/hands-on input from the QA manager.

The types of audit we conduct include system, process and for cause at:

• Sponsor audit
• Investigator site audit
• Third party service provider (e.g. Contract Research Organization CRO) audit

In addition, we also provide GCP mock inspection, conducted by a former GCP inspector from the Danish Medicines Agency.

Inspection preparation and coordination

Preparation and coordinating of an inspection is a stressful process due to short timelines, complexity and pressure. The consequences of a failed inspection can be dire. With our experience, we assist you to get the process going more smoothly with following activities:

• Training of involved staff on how to act during inspection incl. rehearsal (do and don’t rules)
• Planning (overview of roles and tasks, communication etc.)
• Overview of documents and systems
• Coordination of activities during the inspection
• Advice to inspector’s request

Quality Management System (QMS)

Quality is license to operate. A good quality management system is the foundation for success in clinical research, inspection readiness and company sustainability.

PharmaGCP will assist you in implementing and maintaining an effective QMS by providing:

• Management of the Corrective and Preventative Actions (CAPA) system
• Audit follow-up
• Optimization of existing QMS
• Gap Analysis
• Advice and preparation of SOPs to assure compliance with GCP requirements
• Handling of clinical non-conformity/deviations
• Support to implementation of EU Clinical Trial Regulations