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, […]
Read MoreGeorge Clinical takes over study management at start of Phase II as a rescue study. SITUATION When George Clinical was called upon to enter this Acute Myelogenous Leukemia Study in Elderly Patients at the start of Phase II, the client was dealing with a non-cooperative CRO, delays in site activation and low subject recruitment […]
Read MoreOne of the most rigorous and largest general population-based HS epidemiological studies reported thus far, for the first time sheds light on the prevalence and impact of HS in Australia as well as the demographic characteristics of the sufferers. SITUATION A large global pharmaceutical company was seeking a partner for a cross-sectional, observational, population-based […]
Read MoreGeorge Clinical delivers India arm of this landmark trial with on-time recruitment and 100% retention. SITUATION “Nearly half of all people with type 2 diabetes will develop chronic kidney disease (CKD), causing a high risk of kidney failure and cardiovascular disease and impacting their quality and length of life, even with the current best […]
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