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.
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.
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.
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.
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
Are Your Medical Products EU Reg-Ready for 2021?
Due to COVID-19, the EU revised the MDR date for conformance and moved it to May 2021. Your medical devices need to be prepared for quality system audits and, depending on the type of device, a review of safety and performance documentation. If you’re unsure about how your products stack up, the CRS team of clinical, science, engineering, and regulatory advisors can assist with the latest requirements to help you comply.
CLINICAL RESEARCH STRATEGIES
An End-to-End Approach to Compliance in Life Sciences
Life Sciences Review, March 2021
“In the EU, while regulations are meant for ensuring patients’ safety by adding more conformance requirements, they have severely compromised the Life Sciences industry’s quest to push the boundaries of innovation,” says Alethea Wieland, the President and Founder of Clinical Research Strategies.
According to a study published by Deloitte, “Globalization, alliances and partnerships, heightened transparency expectations, increased emphasis on innovative technologies, and ever-evolving needs for existing and emerging customers are driving them to re-examine their approach to compliance.”
As such, identifying, analyzing, and mitigating compliance risks have evolved into a fundamental prerequisite for Life Sciences companies in developing an effective strategy to help future-proof their business. However, keeping up the innovation pace with this regulatory landscape will no longer be an easy task, especially for startups and mid-sized organizations.
CRS CAN PLAY A VITAL ROLE IN MAINTAINING THE HEALTH OF YOUR BUSINESS
Let’s talk about bringing integrity, trust and accountability to your entire operation.