Good Clinical Practice Advisory Serves (GCP)
1. Clinical Trail Investigator selections
One of the biggest challenges facing Trail Sponsors is finding Investigator teams with people with the right skills and expertise. Our in-house training and mentoring is designed for providing individuals and groups with the essential knowledge and skills in GCP to be able to conduct a Clinical Trail. We prepare costs effective training solutions based on accurately identified requirements, then commission and manage through each step of the training process.
2. QP release of manufactured/imported Investigational Product.
We'll assist you in the preparation of the Investigational Product dossier from the material manufacturing to packaging and labelling and QP release before use in the clinical trial.
Our services include:
- Making your projects more successful by developing contractor's expertise
- Investigational product importation and release
- Managing packaging and supply for studies from Phases 1 to 3
- Carrying out study-related compliance audits, and following-up with contractor to ensure continuous improvement
3. GCP compliance auditing;
GXP-Engaged Auditing Services GmbH works in association with PharmaConsult Global to provide Quality Management services to companies in the pharmaceutical, biotechnology, medical device, nutrition and related industries, as well as to authorities (EU and US) and academia, since 2003. Our scope of services includes audits and inspection readiness assessments of companies (sponsors, vendors), investigational sites, Institutional Review Boards, and documents in all different GXP areas of pre-clinical and clinical research. We have also been involved in strategic or business development activities of clients such as due diligence programs prior to M&A decisions, internal audits, and SOP writing activities.
Headquartered in Munich, Germany, we provide global auditing services through our network of over 40 contract auditors located around the world. In addition to GCP, G(C)LP, CSV/IT audits we can provide auditors with expertise in GCP with all relevant interfaces.
Audits 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. Inspections are conducted to standards of the EMA, MHRA and FDA.
GXP Expedite core Services include;
- Conducting of audits for clients, covering all areas of clinical studies including…
– Investigational sites and critical suppliers
And key activities like …
– Investigational study site management, – clinical monitoring, – safety management
– Regulatory affairs, – data management, – biometrics, – laboratory analytics
And essential documents, such as …
– Protocols, informed consent documents, – trial master files, – clinical study reports
– Standard Operating Procedures
- Evaluation, review, setting-up and implementing QM systems in client companies, including writing or support with writing SOPs
- Independent full or partial QM or QA coverage of client companies who need additional resources in QM/QA
- Definition of and/or execution of QM and auditing plans for clinical studies