We work to keep every patient engaged to the end, from risk retention matrix and personal contact with CRAs, to patient-facing animation in 20 languages. SITUATION Clinical trials for rare diseases pose specific challenges due to their elusive nature and low patient populations. Research is critical for these often serious and even life-threatening diseases that […]
Read MoreExceptional kidney and metabolic scientific leadership network provides continuity, communication and cultural expertise in long-term global trial program. Background The National Institute of Diabetes and Digestive and Kidney Diseases (NIH) estimates that more than one in seven people with kidney disease have anemia, increasing their chance of developing heart problems and strokes. The prevalence […]
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Ability to work across cultural, language and timeline barriers sets benchmark and achieves record patient recruitment in China despite pandemic. Situation A Canadian CRO conducting a global and important Phase III early breast cancer trial for a major pharmaceutical company engaged George Clinical as its partner for the Chinese portion of the trial. Globally, the […]
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Regulatory knowledge, strong communication skills and flexibility to adapt helped move this novel trial forward. SITUATION George Clinical was contracted by a globally recognized leader in the field of nutritional science to conduct a prospective, multi-center, randomized, open-label clinical trial to compare the effects of immunonutrition in patients undergoing surgery for gastrointestinal cancer with […]
Read MoreHaving a well-respected clinician as part of the team to communicate the scientific value of the research gave valuable credibility and comfort level to referring physicians. SITUATION George Clinical was contracted by a mid-size pharmaceutical company to conduct project management and clinical monitoring in a study to evaluate the pharmacokinetics (PK) and safety of […]
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As a strong proponent of trial innovation with experience in quickly adapting to complex and fluid operations, George Clinical was the ideal partner for the SONAR trial. SITUATION George Clinical was contracted by a large biopharmaceutical company to run operations in the APAC region for SONAR, a randomized, multi-country, multicenter, double-blind, parallel, placebo-controlled study of […]
Read MoreLandmark CREDENCE renal outcomes trial stopped early based on achievement of pre-specified efficacy criteria. SITUATION Five million people are predicted to have kidney failure by 2035. This is a global problem causing not only a diminished quality of life for patients, who are at risk for many adverse health outcomes, but also creating great […]
Read MoreWith tight turnaround and five years after study completion, George Clinical brings new staff up to inspection standards and trial passes inspection with no significant findings. SITUATION George Clinical completed a Phase III, randomized, double-blind, double-dummy, parallel group, local registration trial on cancer pain in 2013 and 2014. The trial covered 28 sites and […]
Read MoreProcesses in multicenter study investigating safety and efficacy of combination drugs in patients with locally advanced or metastatic solid tumors amended successfully. SITUATION George Clinical was contracted by a small to mid-size biopharmaceutical company to conduct a Phase Ib open-label multicenter study investigating the safety and efficacy of combination drugs in patients with locally […]
Read MoreProactive 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, […]
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