Quality Management Coaching
Know what your responsibilities as a trial sponsor are, master procedures, develop essential documents and fulfill the requirements for your investigational product (SAMD, IVD, MD, MP). With our quality management coaching, we offer competent guidance regarding the legal requirements for quality management systems (QMS) in clinical studies and human research projects.
In collaboration with your team, we provide support in establishing a process- and risk-based QMS which is tailored to your human research unit and your specific projects, and which meets the needs of clinical trials and research projects participants, researchers, regulatory authorities and Sponsors. We identify your critical research processes; clarify which Standard Operating Procedures (SOPs) and other essential documents you need and are happy to assist you in setting them up.
We can also support you with assessing and improving your existing QMS before and during your research project activities.
Services
Developing Your Quality Management System
• Defining the framework for an individual QMS
• Training research personnel on quality management and GCP (click here for dTIP GCP courses)
• Guidance on risk assessment and risk management
• Guidance on document control and good documentation practice
• Guidance on required SOPs, provision of SOP templates and examples, review of SOPs, and coaching in creating SOPs and other quality documents as needed
Continuous Improvement, Auditing and Inspection Support
• Independent internal auditing of your QMS structure, processes and documentation by the dTIP team. The audits will allow the identification and the evaluation of risks and areas for improvement, which will maximize inspection readiness and process improvement. You will receive a detailed report with pragmatic recommendations tailored to your research projects to ensure GCP and legal compliance.
• Active support in the preparation for upcoming external audits
• Vendor audits and evaluating external vendors (vendor oversight will be evaluated during an inspection, so it is important that you have control over all delegated tasks)
• Study and research project start-up readiness checks and dTIP audits to identify gaps and propose improvements
• Preparation and accompaniment of Swissmedic inspections by experienced dTIP staff to facilitate the inspection process
• Corrective and Preventive Actions (CAPA) consultation and follow-up
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