Case Studies

George Clinical Conducts First Oncology Immunonutrition Trial in China

George Clinical’s Scientific Leadership Model Proves Critical to Meeting Difficult Recruitment Targets in Atypical Phase I Study of a New Renal Drug

Having 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. 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 a sulfated […]

George Clinical Meets Challenging Recruitment Targets in Complex Renal Trial

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.  

George Clinical’s Scientific Leadership Achieves Exceptional Integration Between Science and Operations with Unprecedented Low Rates of Loss to Follow Up and Withdrawal of Consent

Landmark 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 […]

George Clinical’s Audit Readiness Provides Successful Inspection of Long-Finished Phase III Trial for Chinese Regulatory Agency

With 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 […]

George Clinical Provides Innovative Solutions to Mitigate Risks, Manage Fragile Biological Samples and Improve Patient Experience

Processes 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 […]

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, […]

George Clinical’s Full-Service Offerings Aid Acute Myelogenous Leukemia Study in Elderly Patients

George 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 […]

Epidemiological Study of Hidradenitis Suppurativa (HS) in Australian Population

One 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 […]