Small change. Big impact.
All it takes is one small mutation to change a gene…and a person’s life.
You started out hoping to make a difference in someone’s life…and, in turn, impact the world. That’s because small things truly can make a big impact.
You need a CRO who not only understands that on a very personal level – but one who also has the experience to help you make it happen. For your cell or gene therapy, partner with Worldwide Clinical Trials. We’re here to help you transform small changes into a big impact.
Every cell and gene therapy program is different.
We know that all trials are different. But with cell and gene therapy programs, that’s even more true. That’s why our Cell & Gene Therapy Hub is committed to providing you with a customized team to tackle your specific scientific, regulatory, medical, and operational needs.
Your Worldwide team has built their careers in developing complex cell and gene therapy programs across North America and Europe, and their experience spans all phases, many rare and non-rare indications, and all major treatment modalities. We are committed to following through on timelines and providing patient-focused solutions to build a collaborative partnership that improves outcomes for patients and families.
We specialize in providing end-to-end solutions for adult and pediatric cell and gene therapy programs, leveraging:
- Early strategic and scientific consulting ahead of trial for program success
- Partnerships with global investigators, sites, and vendors
- Our diverse, integrated team for seamless trial execution
- Comprehensive global and local regulatory support
“At Worldwide, we take a true team approach to make your program an operational and strategic success. Along with my global colleagues, I’m committed to working closely with you to deliver that full, end-to-end personalized solution.”
Amy Raymond, Executive Director Therapeutic Strategy Lead, Cellular and Genetic Medicines
Aman Khera, MBA, FTOPRA, FRAPS
VP, Regulatory Science, Strategy and Innovation
Michael Murphy, MD, PhD
Chief Medical and Scientific Officer
Derek Ansel
Executive Director, Therapeutic Strategy Lead, Rare Diseases
Jake Boyd
Director, Project Management
Dana F. Durst
Senior Director, Site Activation & Regulatory Therapeutic Lead, Oncology
Virgilio Garcia Lerma
Senior Director, Regulatory Pre-Award Strategy
Jeff Almrud, PhD
Senior Director, Project Management
Your cell and gene programs deserve a personalized approach.
Early engagement support for collaborative development
We specialize in providing early engagement and consulting services for truly collaborative development. As our partner, you’ll have access to our therapeutic strategy leads, scientific solutions team, regulatory experts, clinical research methodology expertise, and more. With these resources, you can confidently enter the next phase of your program.
Trusted relationships with industry stakeholders
We partner with the global vendors and sites key to helping your trial succeed. Our site relationships provide protocol reviews and investigator feedback and help fulfill your enrollment needs. Whether you opt to employ our logistics coordinator, our vendor partnerships, or partner on a customized approach, you can trust your study’s requirements will be carefully orchestrated.
One united team for seamless trial execution
Our cell and gene therapy offering brings together a diverse and integrated team of specialists from across the globe. From the regulatory support, to the strategy leads, to the CRAs, your Worldwide team has a history in delivering cell and gene studies and is united in offering one seamless trial delivery. Whether you engage with us early or are looking for Long-Term Follow-Up (LTFU) support, we take an integrated and flexible approach to your trial.
Global and local regulatory support
Our team of regulatory experts have supported diverse cell and gene therapy products across North America and Europe. Our global and local regulatory experts maintain a strong understanding of regulatory pathways in their area and can support you with local agency engagement.
We are here to help with your next project.
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