RISK MANAGEMENT & QUALITY ASSURANCE
Risk management and quality assurance are foundations of all life sciences companies. The CRS Team will customize your risk management and quality assurance programs, including building or repairing your quality management system. We can audit your suppliers and/or vendors.
Some of our specialized programs have included:
- Review of GDPR and Privacy contracts and informed consents for an oncology Sponsor in a global phase III study
- Select collaboration with law firms and third-party Data Privacy Officers (DPOs) and Data Privacy Representatives (DPRs) to provide support to close gaps of risks
- Developing Privacy/HIPAA/GDPR staff training programs and recording it for future use
- Hazard Analysis, Failure Mode and Effects Analysis (FMEA) in medical devices
- Management Review
- Gap analysis of standards
- Quality management systems (QMS) build for start-ups
- Review of FDA submission feedback to lay clearer pathways forward
CRS Steps in to Help Recalibrate and Conform
An imaging medical device company divested some of their business units which resulted in a significant reduction in force (RIF). To comply with the current EU MDR, Clinical Research Strategies was hired to re-write the company’s clinical SOPs and recalibrate their efforts to conform, while ensuring compliance with multiple global markets (US, Canada, EU and Asia-Pacific). We addressed a major non-conformance and CAPA from a Notified Body audit finding, wrote ten Clinical Evaluation Reports and three Literature Reviews covering over 80 individual devices, trained the Research and Development (R&D) team on the conduct of clinical research studies, assisted with the formal close-out of a forgotten clinical study, and established a single Clinical Evaluation Plan (CEP) for dozens of the legacy device families.
CRS CAN HELP YOU BALANCE RISK WITH COMPLIANCE
Contact us today for a free phone consultation.