Study helps yield full approval for investigative product by FDA for IgAN patients at risk of progression. Situation IgA Nephropathy (IgAN) is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure. Primary IgAN can occur at any age, with typical onset during second or third decade of life. […]
Read MoreDownload The Complete Case Study The determination of strong scientific leaders keeps trial on track to provide valuable data. SITUATION Despite optimal current care, up to 30% of people suffering from IgA nephropathy (IgAN) will develop kidney failure requiring dialysis or kidney transplantation. The largest corticosteroid trial in IgAN completed to date provided valuable […]
Read MoreDownload The Complete Case Study George Clinical Exceeds Recruitment and Retention Goals in Important Global IgA Nephropathy Study At the peak of the COVID pandemic, recruitment was met, and patient visits continued safely. SITUATION IgA Nephropathy (IgAN) is a disease with a relative lack of progress in innovation and a population largely absent from […]
Read MoreDownload The Complete Case Study Early risk identification and comprehensive quality management plan ensured best possible outcome. SITUATION Neoantigen vaccines have appeared only recently as emergent immunotherapy and show great promise. Biopharmaceutical companies developing these drugs often have few resources and no experience in conducting the unique and complex clinical trials associated with […]
Read MoreDownload The Complete Case Study Collaborative teamwork results in success for this study involving rare indication in a pediatric / young adult population. According to research, emerging biopharma companies (EBPs) are responsible for two-thirds of all molecules in the R&D pipeline, and many of the drugs in development are promising candidates for rare diseases. […]
Read MoreDownload The Complete Case Study Early phase oncology expertise and established local relationships make George Clinical the CRO of choice for Chinese biotech. Situation Our organization’s nimble, flexible approach to early phase oncology trials was a large benefit to an innovative, global Chinese biotech for a phase I, multicenter, open-label, dose-escalation, oncology clinical […]
Read MoreDownload The Complete Case Study First patient screening in seven months avoided lapse in Chinese regulatory approval. SITUATION A pharmaceutical sponsor with a US Phase III metastatic pancreatic cancer study had previously applied for Chinese regulatory approval (NMPA). However, due to the impact of COVID-19 and other administrative reasons, no site identification or […]
Read MoreDownload The Complete Case Study Challenges included specialized equipment, interaction with multiple departments and stringent COVID restrictions. SITUATION George Clinical was chosen by a biopharmaceutical company focused on neurodegenerative disease to conduct a Phase II, randomized, double-blind, parallel group, placebo controlled clinical trial for the treatment of visual pathway deficits in chronic optic […]
Read MoreDownload The Complete Case Study Despite operational delays, COVID interruptions and Ukraine war outbreak, targets were met. SITUATION George Clinical was chosen by a large pharmaceutical company to provide scientific leadership services across all participating countries in an ongoing Phase IIb, randomized, double-blind, placebo-controlled, multicenter study to assess the reduction of albumin in […]
Read MoreDownload The Complete Case Study Local knowledge combined with Australia’s favorable conditions keep trial on track and on time. Early phase clinical trials are the first-line research studies in drug development and assess therapies for safety, dosage levels and side effects. These studies form the basis for all further research on therapy, so they […]
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