George Clinical Guides Sponsor with Limited Clinical Trial Experience in Phase II Melanoma-TIL Trial

Proactive identification of issues potentially affecting trial outcome led George Clinical to step in and provide services above and beyond original statement of work with full services, from protocol amendment to expanding manufacturing capabilities and easing patient waiting times.

 

SITUATION

George Clinical was contracted by a small biotechnology company for a Phase II, multi-center, single-arm study to assess the safety and efficacy of cell transfer therapy using autologous tumor infiltrating lymphocytes (TIL) followed by IL-2 treatment of patients with metastatic melanoma.

As George Clinical has conducted over 300 oncology studies, we were a good fit for a small company with limited clinical trial proficiency and in the process of rapid expansion of their clinical trial team. Our extensive experience includes all phases of oncology programs including, Maximum Tolerated Dose (MTD), Phase I, II and III and late-phase trials, health economics and outcomes research. Our full services team is comprised of scientific leaders, doctors, nurses, biostatisticians and trial management professionals who work together to ensure timely delivery of quality trial data. Our scientific leadership model is recognized internationally as being highly effective in helping sponsors implement the most effective trials possible with innovative solutions that produce quality outcomes within tight timelines and limited budgets.

 

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