September 25th, 2024
CRO CoC: Level up Your Compliance to the Latest GDPR Standards with MyData-TRUST
Data protection has become a critical global concern, and there is an increasing need for companies to strengthen their compliance – especially with new standards emerging!
Recently, the first pan-European code for clinical research, the EUCROF CRO Code of Conduct for Service Providers in Clinical Research was adopted by CNIL on its plenary meeting of September 12, 2024. This code has undergone the review by all EU member states and with CNIL’s resolution no. 2024-064, which approves this code, the formal approval process of the EUCROF Code is now completed. The Code is set to become a key reference in the clinical research sector globally. In response, many companies, in particular, Clinical Research Organizations (CRO), are working to ensure their compliance levels align with these new standards.
Why Choose the CRO CoC Adhesion?
Adhering with the EUCROF CRO Code of Conduct is about more than just ticking boxes—it’s about securing the trust of your clients and demonstrating your commitment to safeguarding personal data in clinical research. With the CoC poised to become an essential standard for any CRO, key benefits are:
- Stay Ahead of Regulations: With the EUCROF Code of Conduct quickly becoming the new standard in clinical research, ensuring compliance now will protect your business for the future and give you a competitive edge.
- Boost Trust , Credibility and get a Competitive Advantage: Demonstrating compliance with the CoC enhances your reputation with clients, partners, and stakeholders, building trust in your ability to protect sensitive data.
- Reduce the GDPR vendor assessments: Compliance with the code guarantees the adequacy of your processes to your clients and could validly replace the GDPR vendor asessments, thus saving your time and money.
- Tailored Recommendations: Our team of experts provides actionable insights, ensuring that the steps you take are perfectly aligned with your organization’s unique needs and the CoC’s requirements.
- Prepare for Adherence: Our CRO CoC Readiness Assessment not only evaluates your current level of compliance but also prepares you for adherence, positioning your business as a leader in data protection.
How can MyData-TRUST help?
For all clinical research vendors aiming to stay at the forefront of compliance, aligning your data protection practices with the CoC is now essential. That’s where MyData-TRUST (MDT) steps in with its CRO CoC Readiness Assessment, a comprehensive solution designed to evaluate and enhance your preparedness for CoC compliance. Our assessment ensures that your organization is not only meeting current requirements but also ready for the adherence to this new standard.
Our assessment process is specifically tailored to meet the needs of companies in the Life Sciences sector, such as CROs, biotech firms, and pharmaceutical companies. Here’s how it works:
- Define the Scope: We begin by determining the services and specific business activities or data processing operations that will be assessed under the CoC.
- Evidence Collection: Our experts will analyze the processes and documentation in place, and a representative sample of your practices to evaluate your current level of compliance with the CoC and its controls.
- Assessment Report: A draft report is provided, detailing our findings, identifying gaps, and offering practical recommendations for improvement.
- Action Plan: Based on the report, you can create a targeted action plan to address any gaps and improve your overall compliance. Once completed, we provide the final report, ensuring your readiness for CoC adherence.
Gap Analysis versus CRO CoC Readiness Assessment
While the CRO CoC Readiness Assessment focuses on evaluating the maturity and effectiveness of your current compliance program in the scope of the CRO CoC, our Gap Analysis offers a broader view. It maps all data processing activities within your organization and identifies specific Corrective Actions (CAPA) to improve compliance.
If you’re unsure which type of assessment best fits your needs, our experts are here to help you choose the right solution based on your business activities and goals.
Why MyData-TRUST?
At MyData-TRUST, we understand the complexities of data protection in the clinical research sector. Our team of qualified experts specializes in guiding organizations like yours through the requirements of the EUCROF CRO Code of Conduct. We don’t just assess your compliance, we equip you with the tools and knowledge needed to enhance your data protection strategy, mitigate risks, and ultimately achieve compliance and adherence.
By choosing MD-T, you’re not just preparing for compliance, you are investing in the future success of your business.
Take the First Step Toward CoC Compliance
With the adoption of the EUCROF CRO Code of Conduct, now is the time to take action. Let MyData-TRUST guide your organization in aligning with this crucial standard. Contact us today to schedule your CRO CoC Readiness Assessment and prepare for adherence.
Anastassia Negrouk
Emeraude Camberlin
