A comprehensive approach to cell and gene therapy clinical development

Over 18,000 patients from 70 countries have participated in 210 cell and gene therapy trials since 2012. These advances in cell and gene therapy represent innovative treatments, particularly where traditional methods fall short, but require navigating new risks. Our multidisciplinary teams are ready to deliver life-changing treatments to patients sooner.

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). Working extensively with biotech and large pharma clients, we 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.

Facts

Medical Expertise

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 provide cell and gene therapy insights, advising on protocol design, regulatory strategies, 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.

Clinical Delivery Expertise

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.

Global Site Network

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.

Patient Recruitment & Engagement

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.

Real World Evidence Solutions

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.

Regulatory Solutions

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

Pre-Clinical Solutions

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.

Laboratory Solutions

IQVIA Laboratories offers an extensive array of CAGT lab solutions to meet the unique demands of CAGT clinical development. The use of alternative treatments such as Cell and Gene Therapies (CAGT) holds great potential for bridging the gaps left by traditional treatments. These innovative CAGT clinical development programs require a suite of complex laboratory assessments to satisfy regulatory submissions and support Proof of Mechanism, Pharmacodynamic, Safety and Efficacy investigations. With our global laboratory network and industry leading subject matter experts, we are ideally positioned to shape, validate, and deliver those biomarker assessments.