Case Studies Archive | George Clinical

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

By George Clinical

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 […]

September 19th, 2020

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

By George Clinical

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 […]

July 21st, 2020

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

By George Clinical

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, […]

May 11th, 2020

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

By George Clinical

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 […]

May 7th, 2020

CREDENCE¹ Renal Outcomes Trial: India Operations Successfully Conducted

By George Clinical

George 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 […]

April 10th, 2020

Epidemiological Study of Hidradenitis Suppurativa (HS) in Australian Population

By George Clinical

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 […]

January 22nd, 2020

New Formulation ROTAVAC 5C Has the Lowest Cold Chain Footprint Amongst Oral Rotavirus Vaccine in the World

By George Clinical

Seamless coordination of complex pediatric Phase III clinical trial for ROTAVAC 5C® in India brings world closer to improving the global supply of affordable rotavirus vaccines. SITUATION George Clinical was selected by sponsor Bharat Biotech to conduct a seamless, sequential Phase III, randomized, multi-center, single-blind study to evaluate immunogenicity, safety and reactogenicity of liquid […]

November 13th, 2019

George Clinical leads China Component and Recruitment in World-First Large CPAP Device Trial

The Study Although Obstructive sleep apnea (OSA) is a very common condition that is associated with an increased risk of cardiovascular disease (CVD), there is much uncertainty over the effectiveness of treatment with nasal continuous positive airway pressure (CPAP) for the prevention of CVD. The SAVE trial was a multi-centre, open label, parallel, prospective, randomised, […]

June 20th, 2017

George Clinical Scientific Leaders boost recruitment for Phase 1 Patient Study

Utilizing key therapeutic knowledge leader networks as championed by George Clinical has again shown its effectiveness in boosting recruitment; this time for a Phase 1 renal patient trial. It is widely understood that the recruitment of patients into a Phase 1 trial can be fraught with difficulty. This difficulty arises from: A lack of established […]

January 23rd, 2017

Scientific Leadership: Our Communication Framework

Background George Clinical provides scientific leadership to clinical trials, where peer-to-peer engagement from clinicians is leveraged to facilitate study operations. In the traditional study operations model, clinical research associates (CRAs) typically engage with site personnel, such as study coordinators, on a day-to-day basis. Principal investigators, whose expertise and seniority at the site’s operational hierarchy, is […]

January 23rd, 2017