US
Kidney & Metabolic – George Clinical

Kidney & Metabolic

George Clinical has established a reputation as the clinical research organization of choice for conduct of renal trials.

Kidney & Metabolic

George Clinical: The Clinical Research Organization of Choice to Conduct Renal Trials

Facilitated by a kidney site network considered to be one of the strongest in the world, especially in the Asia Pacific region, George Clinical owns an enviable position as a trusted partner in kidney and metabolic clinical research around the globe.  Our scientific expertise collaborates with sponsors to develop new strategies for the prevention and management of renal and metabolic disease specifically including dialysis, chronic kidney disease (CKD), focal segmental glomerulosclerosis (FSGS), diabetic kidney disease, acute kidney injury and IgA nephropathy as well as the utility of genetics in drug development and discovery.

 

How does George Clinical set the standard in kidney and metabolic trials?

George Clinical leverages the in-depth expertise of our scientific leadership to design effective studies, select the best sites from more than 20 countries internationally, and accelerate recruitment. Our scientific leaders generate strong evidence to implement real change in treatments, clinical practice and policy.

 

What are we doing to continually improve studies?

      • Sponsors markedly benefit by collaborating with us from the earliest stages envisioning a trial to the final detailed meta-analysis and clinical conclusions
      • Aligning with a veteran CRO partner such George Clinical versed in everything from protocol design, site analysis, project management and regulatory compliance reduces both the time to initiate and complete studies as well as the risk of disruption or study failure
      • Continuing to advance clinical research methods in this space, George Clinical launched the Global Kidney Patients Trials Network to improve sponsor’s path to market while reducing overall study cost
      • By bringing patients, established sites, sponsors and trials closer together, GKPTN strengthens the global kidney disease research community’s capacity to facilitate more rapid translation of new interventions from research into practice

 

What should a sponsor expect from working with us?

Working with George Clinical means studies activate quicker, recruit thoroughly, and meet or exceed budgetary expectations through the continuous support of dedicated, regionally savvy, cross-functional teams.

How do we efficiently help make renal trials a reality? We facilitate:

  • Scientific leadership
  • Advisory boards and designing protocols
  • Selecting best possible clinical sites and reference requirements for various global environments
  • Statistical analysis and data management
  • Safety, quality and pharmacovigilance
  • Regional regulatory interfaces and endpoint adjudication

 

Unparalleled Kidney Research Experience

George Clinical has earned a reputation as the leading kidney and metabolic CRO through a broad resume of landmark studies. 

Leading the Way in Kidney Research — Renal Scientific Leadership

Accelerating kidney research and improving the quality of care for patients with kidney disease requires innovative thinking and challenging the status quo. Our team of leading scientific leaders and operational experts connect key opinion leaders, investigators, research sites, patients, regulators and clients with a common purpose and an innovative operational platform for conducting kidney clinical trials.

George Clinical's Kidney & Metabolic Scientific Leadership

Professor Heerspink’s principal research interests include optimizing current treatment strategies and finding new therapeutic approaches to halt the progression of renal and cardiovascular disease in patients with diabetes with a specific focus on personalized medicine. He is Professor of Clinical Trials and Personalized Medicine; Clinical Pharmacologist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, the Netherlands; and visiting professor at the University of New South Wales in Sydney. He worked as a Postdoctoral Fellow at The George Institute for Global Health, Sydney, Australia, where he investigated the effects of blood pressure-lowering regimens on renal and cardiovascular outcomes in patients with chronic kidney disease.

Professor Heerspink leads and participates in clinical trials focused on renal and cardiovascular complications of Type 2 diabetes. His main expertise includes clinical trial design and personalized medicine as well as methodological aspects and statistical analyses of clinical trials. Based on his work at The George Institute, he was awarded a young investigator grant and subsequently in 2015 a consolidator investigator grant from the Dutch organization of scientific research and received in 2016 the Galien award for his research. 

Professor Gallagher’s research interests include large scale clinical trials exploring ways to improve outcomes of kidney patients with a focus on acute kidney injury, long term treatment effects, and applying research evidence into practice. He is Associate Professor, Faculty of Medicine, UNSW, Sydney; Director of the Renal and Metabolic Division in The George Institute for Global Health; and a clinical nephrologist in the Renal Dept. at Concord Repatriation and General Hospital. He works extensively in the ANZ Society of Nephrology in renal guidelines and clinical policy.

Professor Gallagher is interested in the use of multi-disciplinary approaches and innovation to address major non-communicable health threats and works extensively in renal guidelines and clinical policy. At The George Institute for Global Health, he serves as Program Director, Acute Kidney Injury and Trials.

 

 

Professor Barratt’s research is focused on pathogenesis of IgA nephropathy and a range of areas across renal medicine including glomerular disease, multi-system renal disease and complications of chronic kidney disease, in particular renal associated anaemia. He is the IgA nephropathy Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases and leads the Renal Research Group within the College of Life Sciences, University of Leicester. He also participates in other IgA nephrology  initiatives such as the International IgA Nephropathy Network and in workgroups identifying endpoints for clinical trials such as the FDA and ASN Kidney Health Initiative.

Professor Barratt has been Principal Investigator for international randomized controlled clinical trials in IgA nephropathy and has attended both the FDA and EMA as an expert witness for new therapies in IgA nephropathy. He is an Editorial Board member for Kidney International and Clinical Journal of the American Society of Nephrology and sits on the Kidney Research UK Grants committee. 

Dr. Jha’s research is focused on understanding the health and societal impact of kidney diseases globally and developing affordable, scalable and sustainable primary and secondary prevention tools. He is Executive Director, The George Institute for Global Health, India; President of the International Society of Nephrology; and Chair of Global Kidney Health, Faculty of Medicine, Imperial College of London. He serves on several international advisory boards, including membership of the WHO Expert Advisory Panel on Human Cell, Tissue and Organ Transplantation and the executive committee of the International Society of Nephrology.

Dr. Jha is recognized as a global expert on kidney disease, and focuses on emerging public health threats globally and in India. He has led research projects operating in more than 20 countries and works with a network of nephrologists to design and implement clinical studies for finding solution to the burden of kidney disease in India. He is particularly interested in using multi-disciplinary approaches and innovations to address the system level health and economic challenge posed to humanity by non-communicable diseases.

 

 

Dr. Liew’s research interests include glomerular diseases, peritoneal dialysis and diabetic kidney disease. He is a member of the Executive Committee of the ISN and chairs the ISN Oceania-Southeast Asia Regional Board. He serves as Senior Consultant Nephrologist and Director of The Kidney and Transplant Practice at Mount Elizabeth Novena Hospital, Singapore, and is a member of several KDIGO Guideline working groups.

Dr. Liew is responsible for the implementation of renal initiatives in Singapore and in the development of glomerular disease and peritoneal dialysis programs in Southeast Asia. In 2020, he became the only Singaporean and Southeast Asian to receive the John Mayer Award from the International Society for Peritoneal Dialysis, an award that honors individuals who have made significant contributions to the field of peritoneal dialysis. He chairs the Asian-Pacific Society of Nephrology Guideline working group on diabetic kidney disease and Dialysis Sub-group for the ISN Global Strategy for End-Stage Kidney Disease. He is also the national leader and global steering committee member for various multicentre clinical trials.

Roberto Pecoits-Filho, MD, PhD, FACP, FASN

  • Professor of Nephrology at the School of Medicine, Catholic University of Paraná State in Brazil, Senior Research Scientist, Arbor Research Collaborative for Health in the USA

Dr. Pecoits-Filho’s research is focused on chronic kidney disease and he is currently a Visiting Researcher at The George Institute for Global Health, Sydney. He was a member of the Executive Committee of KDIGO and the International Society of Nephrology (ISN) and is currently the chair of the ISN Education Working Group, and part of the Core Group of ISN’s Advancing Clinical Trials Initiative. He is Senior Research Scientist at Arbor Research collaborative for Health; Professor of Medicine at the Pontifical Catholic University of Paraná in Brazil; and a practicing nephrologist.

Dr. Pecoits-Filhoh has played an active role in study design, implementation, coordination, event adjudication, data management and data monitoring safety for various trials. His participation in clinical trials includes as Principal Investigator, National Leader and Chair or member of steering committees. He has been featured in a series of ISN podcasts covering the diverse topics related to the field of nephrology and current issues that impact nephrologists around the world.

Dr. Wong’s research interest is in understanding the pathomechanism of kidney fibrosis and he has actively promoted the development of both clinical and pre-clinical research in delaying CKD progression in diabetic nephropathy, IgA nephropathy, and management of cardiovascular complications associated with CKD. He is a renal physician and Senior Staff Specialist at the Royal North Shore Hospital, Sydney; Senior clinical Lecturer of University of Sydney and University of NSW; and Senior Research Fellow, Renal & Metabolic Division for The George Institute and at the Kolling Institute. 

Dr. Wong currently serves as the Head of the Renal Clinical trial unit at the RNSH and Co-Chair of the Research Group for the Chronic and Complex Medicine Network for Northern Sydney Lower Health District (NSLHD). He is the Deputy Chair of the Oceania South East Asia Regional Board, International Society of Nephrology (ISN) transitioning to Chair in 2021. As a member of the Working Group for Clinical Practice Guidelines for Diabetic Nephropathy for the APCN he has a focus on lower and middle income countries. He has been invited as Vice-Chair of the Program Committee for the Asia Pacific Society of Nephrology (ASPN) 2021 in Thailand.

https://scholar.google.com/scholar?hl=en&as_sdt=0%2C43&q=muh+geot+wong&btnG=

Dr. Wheeler’s research interests are in chronic kidney disease complications, specifically those that increase cardiovascular disease burden and/or accelerate kidney failure progression. He is Honorary Consultant Nephrologist at the Royal Free London NHS Foundation Trust and Professor of Kidney Medicine at University College London. He has participated in developing and running several large-scale clinical trials testing lipid-lowering regimens, calcimimetics, and sodium-glucose cotransporter 2 inhibitors in patients with chronic kidney disease. He has developed clinical practice guidelines for several organizations.

Dr. Wheeler is a Research Partner with The George Institute for Global Health and has developed clinical practice guidelines for several organizations, most recently for Kidney Disease: Improving Global Outcomes (KDIGO), of which he is currently Co-Chair. He is Clinical Lead for Division 2 of the North Thames Clinical Research Network and heads a team of eight Clinical Trials Nurses/Practitioners at the Centre for Nephrology, Royal Free Hospital in London. He is Past President of the UK Renal Association, past chair of the UK Renal Registry and currently National Institute for Health Research (NIHR) National Specialty Lead for Nephrology.

Vlado Perkovic, MBBS, PhD, FRACP, FASN

  • Dean of Medicine & Scientia Professor, UNSW

Professor Perkovic’s research is focused on clinical trials and epidemiology, including the prevention of progression and complications of kidney disease. He is Chair of the International Society of Nephrology Action for Clinical Trials group; Dean of Medicine and Scientia Professor at UNSW; and Professorial Fellow at The George Institute for Global Health. He also serves as Staff Specialist in Nephrology at the Royal North Shore Hospital.

Professor Perkovic has been involved in developing global guidelines for kidney disease, cardiovascular risk assessment and blood pressure management. He has made significant contributions with his work on diabetic nephropathy and studies of blood pressure lowering, lipid lowering and a range of other interventions for the prevention of kidney failure and cardiovascular outcomes in people with kidney disease.