COMPLIANCE, GOVERNANCE & DUE DILIGENCE

CRS can help your organization balance the need to protect its integrity and reputation with maximizing business performance. Look at our team as a reality check on your organization, enabling your business to grow faster without veering off the track.

EU MDR

We know the intricacies of how to interpret and apply the EU MDR especially related to risk management, clinical evidence, post-market follow-up studies and routine surveillance and complaint handling. We will help you gain compliance and be inspection-ready. We can write your clinical evaluation reports and literature reviews and build a defendable maintenance plan. This includes your clinical evaluation plan and/or post-market clinical follow-up plans per device family.

SOPs

We customize and build your quality management system from scratch: medical device, clinical affairs and quality assurance components. We are also prepared to harmonize your SOPs post acquisition of other entities.

Governance

We review your corporate policies and identify gaps or business contradictions. We write the policy, train your staff and help ensure you are keeping squeaky clean. Our latest projects: ICH GCP / ISO14155 Compliance, 21 CFR 312, 21 CFR 812, GDPR, HIPAA/Privacy, Travel Policies, Confidentiality, Code of Ethics and Conduct, and Publications Policy. What better way to establish and maintain a healthy and sustainable, transparent culture of trust between staff and clients.

Trial Master File (TMF) Management

Our experienced team of senior research consultants builds, repairs and maintains a clinical trial’s TMF in paper or in electronic format. We have used numerous e-TMF systems and can take on the hardest program for the life cycle, for auditing a TMF, or for rescuing a TMF from other parties.

Due Diligence

We assess the quality of clinical data and quality management systems to de-risk an acquisition target. Through our other partners, we can aid in deeper multi-disciplinary dive and review.

Here’s what else we can do…

• Executive-level Corporate Start-up and Corporate Operations
• Perform Quality Assurance Audits
• Prepare you for Inspection-Readiness
• Assist with 483 and Warning Letter Remediation
• Create a Fair Market Value Analysis
• Create Corporate Sustainability Plans
• Perform Risk Assessments and Gap Analyses
• Establish Requirements for Contract Management
• Develop HR Functions, On-boarding Plans, and Employee Development Programs
• Customize Job Descriptions and Organizational Manuals
• Lead KOL, Scientific, Medical Advisory Board Contracting and Management
• Write Committee Charters