Cell & Gene Therapy

Enterprise planning for a competitive and growing market. With so many stakeholders in the field of cell and gene therapy, it’s essential to partner with an experienced team that can support your trials to ensure efficiency, compliance and safety. Now, organizations of all sizes can meet the future with confidence.

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Expert guidance and deep intel to achieve your goals and drive the future of health

The recent successes of approved cellular and gene therapies have resulted in a surge of interest by biopharmaceutical developers. In fact, the gene therapy industry is expected to grow 30% year over year in R&D spending to help treat diverse therapeutic indications. With this growing market comes a variety of challenges that sponsors, CROs, and research sites must consider when running these trials. While this research provides the opportunity to uncover greater value for treatment, there should be no roadblocks along the way that impede the chances of trial success. Unfortunately though, there are.

So that’s exactly why we created WCG Cell & Gene Therapy: to help organizations bring life-changing therapies to patients who need them most. We do this by helping sponsors and CROs identify hard-to-find patient populations, reduce their exposure to risk, and increase the overall value of the asset being studied.

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Deep relationships with 3,000 sites well-known for C&GT research
Industry partnerships with InformedDNA and Inspire to help execute more effective trials
Expertise in reviewing more than 5,000 cell or gene therapy clinical trials

What you can expect when working with WCG’s Cell & Gene Therapy team

There’s a lot to plan for in your clinical trial, and it's normal for uncertainties to arise. By partnering with WCG, we'll help you make informed and confident decisions via the culmination of six best-of-breed services. When you choose to work with WCG, you can choose to leverage our expertise and operational prowess for all of these services, or a few of them based on your needs. Whichever route you take, our expertise will position you for great success.

Protocol Planning

Work with a team of 950 experts who evaluate endpoints, sample size, statistical analysis plan, study procedures, and I/E criteria. Their insights will enable more informed decision making.

IBC Review and Administration

Receive efficient, thorough review by the leaders in IRB and IBC administration. Since 2000, we’ve reviewed 98% of all cell or gene therapy trials: more than 5,000 trials total.

Site Identification and Feasibility

Know which research sites are most likely to enroll participants for your trial with our performance data on 160k global PIs.

Site Training

Obtain automated crediting for completed training, eliminating redundancy and saving your sites more than 200 hours on each study.

Patient Engagement

Mitigate site staffing shortages and constraints by deploying research professionals to your exact portfolio needs. When deployed, companies have seen a 44% increase in patient enrollment.

Data Monitoring Committee

Enhance trial integrity with un-blinded “easy to evaluate” data package by tapping into our network of more than 950 medical, statistical and safety experts.

Our footprint across cell & gene therapy is expansive

Deep expertise in a broad variety of specialties

  • Oncology
  • Cardiovascular
  • Diabetes
  • Rare and Ultra-Rare Diseases
  • CNS
  • Retinal

Knowledge and experience that is proven

WCG IRB has reviewed 98% of all cell or gene therapy trials: more than 5,000 trials total.

Guidance from world-renowned partners in research

With InformedDNA and Inspire, we’re helping tackle the challenges of identifying, recruiting, and managing patients in clinical trials.

Featured experts that will guide your research strategy from start to finish

Photo of Daniel Kavanagh

Daniel Kavanagh, PhD

Senior Scientific Advisor, Gene Therapy, WCG

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Photo of Sandra Smith.

Sandy Smith, RN, MSN, AOCN

Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG

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Bio photo of Suzanne Caruso

Suzanne Caruso

Vice President, Clinical Strategic Solutions

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Bio photo of Seth Halvorson

Seth Halvorson

General Manager, WCG ThreeWire

Lindsay McNair photo

Lindsay McNair, MD, MPH, MSB

Chief Medical Officer, WCG

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Photo of Janet Wittes.

Janet Wittes, PhD

Founder and President, WCG Statistics Collaborative

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Putting our clients at the center of everything we do

“I’ve been working with the WCG team for the past few years, and we’ve truly appreciated the guidance, expertise, and assistance in navigating this ever-changing regulatory space. The team has been very helpful, professional and friendly, and WCG continues to lead and direct the process asking for our feedback every step of the way.”

– CLINICAL PROJECT MANAGER, BIOPHARMA ORGANIZATION

Putting our clients at the center of everything we do:

“I’ve been working with the WCG team for the past few years, and we’ve truly appreciated the guidance, expertise, and assistance in navigating this ever-changing regulatory space. The team has been very helpful, professional and friendly, and WCG continues to lead and direct the process asking for our feedback every step of the way.”

– CLINICAL PROJECT MANAGER, BIOPHARMA ORGANIZATION

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WCG Cell & Gene Therapy Resources

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Schedule a consultation with our experts

Complete the form to schedule complimentary consultation with our experts today. We’ll help assess your need, and discuss how WCG can assist.