Dr. Jörg Quade offers independent full or partial QM or QA services to clients in need for additional resources in QM/QA.
Audits conducted by Dr. Jörg Quade follow the standards of ISO 19011 and the ENGAGE Optional Guideline for compliance and Quality Systems Auditing from the European Network of GCP auditors and other GCP experts. All audits follow a defined audit plan reflecting the scope and objectives of the audit. Results are communicated via audit reports.
Inspection readiness programs are conducted according to published standards from regulatory authorities.
Quality Management & Quality Assurance Services include:
- Conduct of audits, covering all areas of clinical studies, e.g.
- Site & vendor audits
- Due diligence audits
- Inspection Preparation and Support
- Trial-Specific QM Plans
- Evaluation, review, setup and implementation of QM systems
- Writing or support with writing of SOPs
- Specification of and/or execution of QM and auditing plans for clinical studies
- Conduct of Audits, covering all areas of clinical studies
Audits may focus on key activities of clinical trials such as site study management, clinical monitoring, safety or data management, regulatory affairs, biometrics, laboratory analytics, or product manufacturing.
Objective of audits are essential study relevant documents such as protocols, patient information, informed consent documents, study related documentation, trial master files, clinical study reports, and Standard Operating Procedures (SOPs) or work instructions.
Services are provided globally