GDPR Compliance &
Consulting for Clinical Trials

In the intricate realm of clinical trials, data privacy is paramount. With the European Union’s General Data Protection Regulation (GDPR) setting rigorous standards, ILIKOS Consulting Group emerges as your trusted partner, ensuring that your clinical trials adhere to these standards and set a benchmark in data protection.

The GDPR’s mandates, while ensuring robust data protection, also bring forth a myriad of complexities. ILIKOS Consulting Group, with its profound expertise, stands ready to guide you through these intricacies, ensuring that your clinical trials remain compliant and that patient data remains sacrosanct.

Why ILIKOS is Your Ideal GDPR Partner:

  • Unparalleled Expertise: Drawing from our vast reservoir of knowledge in advising clinical trial sponsors, we offer actionable and invaluable insights.
  • Customized Solutions: Whether venturing into a phase I study or orchestrating multiple phase III trials, our GDPR solutions are tailored to resonate with your unique needs.
  • A Commitment Beyond Compliance: At ILIKOS, GDPR compliance isn’t just a checkbox. We integrate data privacy into your operations, ensuring holistic protection and compliance.

ILIKOS GDPR Compliance Highlights:

  • Scoping and Data Mapping: We meticulously trace the trajectory of participant data, ensuring GDPR compliance at every juncture.
  • Data Protection Impact Assessments: Prior to any new endeavor, we conduct thorough assessments to pinpoint potential data privacy risks, ensuring proactive measures.
  • Informed Consent Forms Review and Revision: Crafting GDPR-compliant patient consent mechanisms that resonate with the latest guidelines.
  • Internal Policy and Procedure Review: Ensure your internal policies align with GDPR mandates.
  • Privacy Notice Drafting: Crafting transparent and compliant privacy notices that inform and protect.
  • Data Subject Rights Management: Ensuring that the rights of data subjects are upheld and managed effectively.
  • Vendor Management: Overseeing third-party vendors to ensure GDPR compliance across the board.
  • IT Security Review and Remediation: Evaluating IT infrastructures for potential vulnerabilities and recommending remedial actions.
  • Clinical Trial Agreements: Drafting and reviewing legally sound and GDPR-compliant agreements.
  • Data Protection Officer Services: Offering expert DPO services to guide and oversee your GDPR compliance journey.
  • Collaboration Partners: Partnering with industry leaders to ensure a holistic approach to GDPR compliance.
  • Article 27 EU Data Protection Representative: Ensuring representation within the EU for entities based outside the region.

With ILIKOS Consulting Group, GDPR compliance in clinical trials becomes a seamless journey. Our team, fortified with expertise and an unwavering commitment to excellence, stands poised to guide you, ensuring that your clinical trials are compliant and exemplary in data protection.