Why choose IQVIA’s regulatory experts?

IQVIA has implemented robust solutions incorporating cross-functional change for IVDR compliance across our business, from regulatory strategy to site activation and study maintenance. Established partnerships between our clinical trial regulatory management team, leveraging IQVIA’s global presence and experience in managing drug clinical trials, and niche expertise provided by IQVIA MedTech – a business segment recognised for its robust ability to support device and diagnostic manufacturers in performing standalone investigational studies - enable us to provide end-to-end drug and diagnostic development solutions under harmonized operational approaches. IQVIA’s CTRM team has the experience needed to navigate the global combined clinical trial regulatory landscape.

IQVIA’s extensive expertise: With over 100 protocols assessed for IVDR compliance, over 160 authorizations under the EU CTR since 2022, and a repository of regulatory queries, IQVIA’s CTRMs offer unmatched expertise to streamline approvals and minimize risks in global combined clinical trials. The IQVIA CTRM team has IVD subject matter experts, who are on hand to deliver therapeutic and regulatory guidance throughout the lifecycle of your study. By partnering with IQVIA MedTech, who supported over 40 performance studies under EU IVDR, this expertise is further enhanced through access to deep regulatory knowledge and MedTech specialized support.

Established relationships: IQVIA clinical trial regulatory managers are best placed to network with both drug and diagnostic partners and provide end-to-end drug/diagnostic development solutions. This networking capability goes beyond trial delivery to ensure compliant end-to-end compliance. We also offer portfolio-level operational manuals that support the delivery of not just single trials, but portfolio trials under a harmonized approach by IQVIA staff. IQVIA fosters collaborative relationships with our sponsors. We already have a portfolio of combined clinical trials in various stages of development, demonstrating that our sponsors return to us to deliver their complex clinical trials.

Comprehensive and strategic support: IQVIA CTRMs support sponsors from early regulatory strategy through study closure, providing subject matter expertise in biomarker use, document review using validated databases, and aligning regulatory and ethics approvals to ensure trial success. To support EU IVDR readiness and strengthen understanding among pharmaceutical sponsors, IQVIA CTRM—partnering with IQVIA MedTech—delivers tailored training on the combined studies model, easily integrated into the sponsor’s learning management system.

Industry collaboration and innovation: IQVIA is the ACRO chair in the EC COMBINE project to pilot joint submissions of IVD and clinical trials, leveraging its CRO experience to foster patient-centric care and accelerate innovative medicine delivery in the EU.

Conclusion: The complexities of combined IVD and drug clinical trials require enhanced regulatory expertise and guidance. The regulatory considerations for IVDs in clinical trials can often be overlooked, particularly in early phases of drug development. By leveraging IQVIA’s clinical trial regulatory experience, we can manage risks and ensure a successful combined clinical trial application under both CTR and IVDR.