Cell Therapy

Charting a course for cell therapy programs

Cell therapy is redefining the future of medicine—using the body’s own building blocks to answer some of our hardest health questions. As autologous cell therapies expand beyond oncology into autoimmune and degenerative diseases, the opportunities are massive—but so are the risks.

The science is personal. The logistics are unforgiving. And you can’t afford missteps.

Gene and cell therapies are often grouped together, but their needs are vastly different. At inSeption Group, we’ve built a team specifically for the complexities of cell therapy—from regulatory strategy to chain of custody to long-term follow-up. We don't just manage your program—we protect it at every turn.

Guidance from the ground up

We’re not just vendors. We’re partners. Our team works with yours from the earliest planning stages—helping define endpoints, refine protocols, and engage qualified sites—all while anticipating what's next.

Safeguarding the chain of custody

Cell therapy isn't like other modalities. You're not just moving a product—you're transporting a patient’s own living cells. That’s why we treat chain of identity and custody with the same care as the therapy itself.
From vein-to-vein, our job is simple: don’t lose the thread.

Strategic oversight that scales

Our exposure across cell therapy programs gives us the foresight to manage the strategy and the small stuff—because both matter. From long-term follow-up plans to LTFU database integration to handling overnight sample issues, we’re built to think fast, act smart, and stay aligned.

Continuity you can count on

Cell therapy takes time, and the talent needed is rare. Our proprietary approach to resourcing ensures you get senior, specialized experts who stay for the long haul. With an industry-low 6% turnover rate, your team doesn’t just know your trial—they grow with it.

Full-service solutions

  • Study design and protocol collaboration and development
  • Regulatory strategy and agency navigation
  • Accredited investigator and patient enrollment
  • Relationship-first site management and dedicated clinical monitoring
  • Clinical documentation development and submission
  • Logistics support and oversight of Chain of Custody
  • Global Drug safety (including cost-effective long-term follow-up via Argus Safety Database)
  • Portfolio-wide strategic planning

Lets find the answers together

We don’t believe in gatekeeping knowledge that has the potential to change the world. Schedule a free one-on-one consulting call with one of our cell therapy leaders. No obligation, just informed discussion.

Dive Deeper

Schedule quality time today.