Cell & Gene Therapy

A comprehensive approach to cell and gene therapy clinical development

Cell and gene therapies offer tremendous promise where traditional treatments fall short. These innovative therapies require charting new, riskier territory. Our multi-disciplinary cell and gene therapy teams are poised to help you bring life changing treatments to patients earlier.

DNA Sample pipetted into multi-well plate

A broad range of experience and a proven track record of success

We have a unique perspective across the landscape of Cell and Gene Therapy (CAGT). We work extensively with both biotech and large pharma customer and draw upon our broad experiences to craft tailored solutions to help sponsors optimize and accelerate their clinical development.

This is who we are, what we do, and how we're different.

Our expert CAGT Medical and Scientific Team advise sponsors on all aspects of CAGT clinical development


Our CAGT Center of Excellence includes highly experienced physicians and clinical operational experts with direct medical, scientific and clinical development experience in CAGT. We harness IQVIA data and innovations and advise on protocol design, regulatory, clinical operations, real-world evidence needs, specialized lab requirements, and commercialization strategies.


We craft tailored strategies for all aspects of CAGT clinical development, especially clinical trials. We work in partnership with our CAGT clinical operations teams and other IQVIA indication-specific Centers of Excellence.

Our specialized CAGT Clinical Operations and Logistics Management teams expertly deliver CAGT trials.


CAGT trials demand meticulous delivery and management of logistics. We have first in class solutions to optimize CAGT study execution.


For our biotech customers, we have developed an innovative, multi-disciplinary CAGT unit, in which the CAGT Center of Excellence partners with an experienced CAGT clinical operations team to ensure seamless clinical program strategy and delivery.


Our Logistics Management Program features experienced logistics managers, supply chain teams, and partnerships with shipping vendors. We are also experienced in the latest tracking tools and innovations in Chain of Custody/Identity verification.

We leverage data-driven insights and established relationships to identify the best sites.


Our global CAGT site network includes more than 160 sites around the globe, including experienced sites in Asia-Pacific and Latin America. Our CAGT sites have expert research teams, infrastructure for cell and gene therapies, and the necessary CAGT certifications.

We use patient-centered and data-driven approaches to identify and recruit patients


CAGT trials often involve rare, pediatric, and patients with advanced disease. We use patient-centered strategies to ensure patient burden is minimized and proprietary IQVIA data to optimize and accelerate recruitment of these challenging populations.


Our patient engagement toolbox includes tailored CAGT recruitment materials, concierge services, and electronic consent. We also leverage our extensive data and biomarker networks to find and identify eligible patients. Finally, we use innovative approaches to minimize patient burden including decentralized trials and remote data collection.

We use innovative study designs and leverage real world data to streamline CAGT long term follow up


Real world evidence is critical to many aspects of CAGT clinical development. We work in partnership with our Real-World Solutions teams to craft innovative study designs and strategies for long term follow up, natural history studies, and external comparator studies. We also leverage our real-world solutions to inform payor and commercialization strategies.

We provide regulatory strategy, advice, and consulting from pre-registration to post-registration. Our program includes a wide range of services including regulatory intelligence, regulatory maintenance and lifecycle support, marketing applications, accelerated approval designations, INTERACT/Pre-IND/IND consultation, prioritization and target product profiles.

We provide CMC strategy, labeling, and GMP compliance audit support. We also provide Pre-IND and scientific advice meeting consultation. Through an award from the California Institute for Regenerative Medicine (CIRM), we provide pre-clinical services to CIRM grantees.

IQVIA’s Q2 Lab Solutions offers an extensive array of CAGT lab solutions to meet the unique demands of CAGT clinical development.


Our CAGT Center of Excellence works in collaboration with Q2 solutions scientists and operational teams develop bespoke lab strategies informed by specific clinical needs.



IQVIA Connected Intelligence

Drive smarter decisions with IQVIA Connected Intelligence

Our powerful approach brings together CAGT experts, data-driven insights, global site networks, and innovative technologies to help you drive smarter decisions to accelerate CAGT clinical development.

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