Cell and Gene Therapy CRO Services
Deliver your next-generation study with cell and gene therapy expertise on time
Developing cell and gene therapies (CGTs) can be one of the most complex challenges in drug development. But with the right partner, it doesn’t have to be.
20
years of CGT experience
1st
in-industry approvals
93%
on-time enrollment
Cell and Gene Therapy Pivotal Trial Solutions
There is no one-size-fits-all approach to gene therapy and cell therapy trials, but these studies share similar challenges at the forefront of science. Finding the quickest path to market while ensuring patient safety and regulatory compliance requires a seasoned multidisciplinary team — one with a comprehensive understanding of precision medicine and targeted therapies across therapeutic areas and modalities.
PSI ran its first CGT trial two decades ago, and those same project leaders are still here today to support your pivotal phase 2 and 3 studies. They’ll be at your side as you navigate the shifting landscape of these advanced therapies with access to top-tier institutions, local KOLs, and regulatory experts across the globe.
PSI CGT Highlights
- Expertise across oncology, hematology, rare diseases, and other indications
- Involvement in the development of key CGT regulations in new regions
- Experience in rare disease and pediatric populations
Your team made our life much easier, and I always highlight PSI as a CRO number 1 in the country to all pharmaceutical companies I deal with.
PSI Cell and Gene Therapy Experience
Therapeutic Areas | Oncology & Oncohematology |
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Hematology |
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Endocrinology & Nephrology |
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Rare Disease | Â | |
Modalities | Cell Therapy | Autologous Cell Therapies
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Engineered Cell Therapies
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Gene Therapy | Viral Vector-Based
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Specialized CGT Trial Support Services
Dedicated Support Roles
Cell and gene therapy studies require world-class institutions with experienced staff, specialized facilities and equipment, and precise safety processes. For instance, cell therapy study sites should include dedicated cell therapy units, the possibility for ICU admission and 24/7 monitoring, experience with high-dose chemotherapy and (if applicable) Interleukin-2, and multidisciplinary teams that include cell therapists, transplant units, surgeons, medical oncologists, and nursing staff. Working effectively across these departments is critical to enrolling your trial on time.
Your team at PSI will include specialized roles to help navigate this complexity, including our in-house cell therapy nurses, Site Technology Specialists, and Clinical Trial Liaisons. These team members focus on providing sites with the tailored support they need to conduct your trial effectively.
Enhanced Enrollment Analysis and Awareness
Cell and gene therapy trials face many hurdles to patient enrollment, including:
- competing studies
- patient uncertainties and fears
- overall lack of awareness
The PSI Enrollment Roadmapâ„¢ helps you proactively identify these and other barriers through direct feedback from sites and investigators. With these insights, you can better engage potential study participants and develop recruitment tools before they enter the clinical trial process.
PSI CRAs and other key team members assigned to your study also receive specific training for cell and gene studies. This training goes beyond data verification, developing the soft skills to manage and motivate sites in targeted patient awareness initiatives.
Dear PSI team, ​ I am thrilled to share the news of the FDA's approval of [study drug] today and wish to take a moment to thank the entire PSI team for your significant contribution to this momentous achievement! On behalf of the entire team, thank you for all of your hard work, dedication, and collaboration these last 7+ years!
A Hypervigilant Approach to Monitoring
These innovative studies demand a highly attentive approach to monitoring, focusing on real-time data collection and safety oversight throughout the trial as well as long-term follow-up. We’ll help you identify and track the critical data points that impact safety within the EDC system and ensure prompt follow-up when these key risk indicators are flagged, safeguarding patient welfare and the overall integrity of your study.Â
Get in touch with PSI’s cell and gene therapy team
Revolutionary treatments require a revolutionary CRO. Find your team of cell and gene therapy experts with PSI today.
Trusted to Deliver
When you partner with PSI, you work with a team recognized by independent industry organizations and sponsor surveys for what matters most in clinical research: expertise, consistent operational excellence, and reliable delivery.
