Cell and gene therapy clinical research isn’t a straight path.

Let’s navigate its complexities together.

When developing a cell or gene therapy, you need a CRO who understands these therapeutics and has the flexibility to manage the shifting landscape. Worldwide Clinical Trials is a leading, full-service, global CRO that works in partnership with biotechnology and pharmaceutical companies to create customized solutions tailored to meet your program needs. 

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Therapeutic Experts

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Countries, All Regions

Global and Local Regulatory Support

Due to the novelty of cell and gene therapies, the global and local regulatory standards surrounding these treatments are frequently shifting, which is why you need a CRO that stays on top of these changes. At Worldwide, our global and local experts can help support you with local agency engagement, with experience across North America and Europe.

One United Team

For the various services required for these therapies, Worldwide works cross-functionally to bring together an integrated team of specialists, including therapeutic strategy leads, scientific solutions teams, clinical research methodology expertise, and more. Your program will have a team that has a history of delivering cell and gene studies through one seamless trial delivery.

Trusted Relationships With Industry Stakeholders

At Worldwide, we partner with global sites, investigators, and providers to optimize your cell and gene therapy program. Our site relationships provide you with protocol reviews and investigator feedback to help ensure your program meets enrollment needs.

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Cell and gene therapy studies supported

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Average years of cell and gene therapy experience

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Publications and presentations on cell and gene therapy

Comprehensive Clinical Development Services Across All Phases

Worldwide specializes in providing end-to-end, patient-centered solutions for adult and pediatric cell and gene therapy programs, leveraging everything from our collaborative partnerships to comprehensive regulatory expertise. Our cell and gene therapy services include:

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Gene-Modified Cell Therapy

  • Chimeric Antigen Receptor T-cells (CAR Ts)
  • T-Cell Receptor (TCR) Engineered
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Gene Therapy

  • Adeno-associated virus (AAV) vectored in vivo gene therapy
  • Adenovirus-vectored in vivo gene therapy
  • Plasmid DNA
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Gene Editing

  • Autologous gene-edited hematopoietic progenitor cells (HCPs)
  • In vivo gene editing
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Cell Therapy

  • Autologous hematopoietic stem cells (HSCs)
  • Health economics/PRO portfolio planning
  • Autologous mesenchymal bone marrow stromal cells
  • Natural killer (NK) cells
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RNA Therapy

  • Anti-sense oligonucleotides (ASOs)
  • siRNA and sRNA

Our Experts

Derek Ansel, MS, LCGC

Vice President, Therapeutic Strategy Lead, Rare Disease

Michael Murphy, MD, PhD

Chief Medical and Scientific Officer

Aman Khera, MBA, FTOPRA, FRAPS

VP, Regulatory Science, Strategy, and Innovation

Virgilio Garcia Lerma

Executive Director, Global Regulatory Strategist

Dana F. Durst

Executive Director, Site Activation & Regulatory Therapeutic Lead, Oncology

Jake Boyd

Senior Director, Project Management

Amy Raymond, PhD, PMP

Executive Director, Therapeutic Strategy Lead, Rare Disease & Cellular and Genetic Medicines

Client Testimonials

Hear from our past customers about their experience with Worldwide:

“I liked that they customized the rare disease study team. I liked that they’re thinking about a strong cultural match because often that’s not thought about. That’s attractive to our small biotech company because that’s the way we work, too.”

VP of Clinical Science Small Rare Disease Biotech

“They [Worldwide] were the best combination of cost, expertise, and fit from a rare disease project management perspective. And one of the other important pieces is the KOL and patient advisory board coordination… Worldwide saying that they actually do the KOL and advisory board coordination is a big selling point. That tells me that they know who the experts are, they work with them, and they can coordinate these advisory boards for us.”

Head of Program Operations of Clinical Operations Small Rare Disease Biopharmaceutical Company

“I think the way Worldwide focuses the activity on a rare disease study is quite interesting because they know how to manage this type of study and how to obtain or to recruit rare patients. [They] have access to registries, [can] discuss with patient communities, [and] have access to key opinion leaders.”

Director Small Biopharmaceutical Customer

Awards

On May 1st, Industry Standard Research (ISR) announced the 2024 Leadership Awards, recognizing Phase 2/3 CROs for comprehensive excellence across their capabilities, compatibility, expertise, quality, and reliability.

In 2023, Worldwide Clinical Trials was named Most Innovative Clinical Research Organization (CRO) by the Triangle Business Journal (TBJ). This awards program celebrates the achievements of individuals and companies making critical advancements in pharmaceuticals, biotech, ag tech, and beyond, in the Triangle region of North Carolina.

Worldwide Clinical Trials, Inc., (Worldwide) the industry’s leading global, midsize, full-service contract research organization (CRO), has been recognized for excellence and honored in five categories in the 2022 CRO Leadership Awards, based on primary market research from Industry Standard Research (ISR) Reports and presented by Clinical Leader and Life Science Leader magazines. This marks the ninth consecutive year that Worldwide has been recognized as a high-performing CRO based on direct survey feedback from pharmaceutical and biotech professionals.

Over 80% of respondents agreed that midsize CROs, such as Worldwide, provide a strong cultural fit while being able to pivot quickly based on changing customer needs.

Read the full report here