SearchCell and gene therapy trials require integration and coordination across numerous disciplines, such as a leukapheresis center, cell therapy laboratory, investigational pharmacy, in-patient treatment facility, and outpatient clinics. Our team works with sites to confirm they have the requisite equipment and processes, appropriate handling knowledge, and trained staff and expertise to support cell and gene therapy studies and patients. Additionally, investigator relationships, networks, and thought leader support are paramount to concluding a comprehensive site identification strategy and running a high-quality study.
Cell and gene therapies have groundbreaking potential
Pioneering methods that cut through the complex to advance your clinical trial
Cell and gene therapies (CAGT) represent a groundbreaking force in medicine and research. These cell-based and novel gene therapies have the potential to cure a disease. It is this potential to eliminate disease that makes them so revolutionary. For the researchers and developers of these innovative therapies, continuous pursuit to improve the quality of human lives remains at the core of every clinical development decision made toward advancing CAGT therapeutic options.
Developing successful cell and gene therapy clinical trials is a complex process due to many operational challenges and regulatory scrutiny. As biotech companies embark on clinical trial planning and execution, it is critical to find a CRO delivery partner to help anticipate and navigate these operational complexities that arise when designing and running clinical trials for cell and gene therapies.
Our experienced cell and gene team navigates the operational and logistical complexity inherent in CAGT clinical trials with ease, thereby advancing these assets forward along their development pathway for increased patient access.
CAGT Study Management Team
Answering the call for innovation to address specific challenges of cell and gene therapy drug development, we have formed a multidisciplinary Cell and Gene Therapy Study Management team. This comprehensive unit is designed for CAGT-focused biotech partners, integrating the IQVIA Biotech clinical program strategy and delivery with the IQVIA Cell and Gene Therapy Center of Excellence. Together, these groups form your CAGT Study Management team, dedicated to an end-to-end, seamless experience for biotech customers.
Aligned CAGT strategy and delivery
We believe that having our CAGT operational delivery as a streamlined process is at the heart of your program’s success. Because of this, we design your delivery strategy with the following core principles:
- Seamless CAGT solutions applied throughout the study process
- Dedicated CAGT-expert cross-functional delivery teams
- Medical expertise across all therapeutic areas
- Clinical trial design, delivery and logistics support
- Optimized communication to efficiently achieve trial milestones
- Integrate lessons learned and experiences into innovation and value for patients
Site Selection
Regulatory
Global regulatory planning and an understanding of regional landscapes are critical to the success of CAGT development. These trials are often evaluated by specialized committees or local standards and the reviews differ from country to country. The regulatory landscape continues to evolve, for example as recent as the FDA's Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products in January 2024, and it is important for biotech companies to understand the current state and anticipate the future state, both of which may impact their CAGT development goals. Our regulatory experts help customers navigate regulatory considerations with strategic and operational guidance.
Logistics
CAGT clinical trials have tremendous logistical complexities, from the manufacturing supply chain of precious cell materials to the frequency of biospecimen collection during the clinical trial. A dedicated team member will oversee all communication, planning and logistics to minimize risk at sample handovers and ensure compliance and reconciliation of samples. Our innovative technology solutions can help ensure superior compliance and tracking, as well as risk mitigation of the logistics chain.
Experienced Teams
- Supported 200 full-service CAGT clinical trials for biotech sponsors in the past 5 years
- More than 70% of project managers have 3+ years of CAGT experience
- 100% dedicated to biotech customers
Navigating operational complexities
The CAGT Study Management team can help sponsors navigate operational challenges specific to cell and gene therapy trials including site selection and start-up, regulatory requirements, and intense logistical demands of product distribution and biospecimen collection. We provide data-driven guidance to enhance the probability of operational success.
Cell and Gene Therapy Insights
Solution
Cell & Gene Therapy COE
Drive cell and gene therapy development from candidate identification through market authorization.
The Bespoke Gene Therapy Consortium
IQVIA's commitment to shifting the paradigm in rare disease and cell and gene therapies includes leveraging the BGTC's regulatory playbook. The playbook serves as a guiding framework to expedite the delivery of therapies to patients.
We are actively collaborating with industry and nonprofit partners to develop standardized platform-based approaches and streamline navigation of the regulatory pathway. This ongoing effort aims to advance the clinical development landscape for rare diseases.
We are actively collaborating with industry and nonprofit partners to develop standardized platform-based approaches and streamline navigation of the regulatory pathway. This ongoing effort aims to advance the clinical development landscape for rare diseases.
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.
Related Solutions
Real World Evidence
Generate and disseminate the right real world evidence (RWE) to meet stakeholder needs with confidence.
Decentralized Trials
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are.
Integrated Commercial Solutions
Connect data, analytics, domain expertise, and technology to uncover actionable insights and maximize commercial effectiveness.