IMPLEMENT CONTINUOUS QUALITY IMPROVEMENT AND VIGILANCE FOR YOUR PROGRAMS

Mitigate the Risk to Your Stakeholders

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

 

Case Study - Imaging

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.

THE COST OF POOR QUALITY

Who are you kidding when you pick cheap or fast as your primary decision-driver? Are you really saving time and money in the long run? CRS has numerous lessons learned to share with our clients when corners are cut. Quality Assurance, Customer Satisfaction, Service and Sustainability are inextricably linked. Let us be your sounding board for maximizing a culture of quality that works for your business.

CRS CAN HELP YOU BALANCE RISK WITH COMPLIANCE

Contact us today for a free phone consultation.

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