Navigating the Evolving Landscape of Glomerular Disease Clinical Trials
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About this webinar
Executing clinical trials in complex glomerular diseases require moving beyond traditional functional involvement. As treatment paradigms and regulatory expectations for surrogate endpoints evolve, integrating medical oversight, Advanced Clinical Practitioners (ACPs) and Clinical Operations (ClinOps) from early startup through study closeout is critical to trial success. This webinar explores how an integrated, cross-functional approach can support glomerular disease clinical trials from protocol design through study execution.
This webinar presents a practical cross-functional blueprint that bridges early sponsor engagement and protocol design with seamless execution at the site level, while maintaining optimized trial management and regulatory compliance. The featured speakers will explore how embedding nephrology-experienced ACPs alongside therapeutically aligned Medical Monitors and CTMs can help reduce protocol deviations, safeguard primary endpoints and accelerate trial delivery for transformative renal therapies.
Additionally, the discussion will examine how sponsors can leverage transferable experience across glomerular disease indications even when disease-specific precedent is limited, applying integrated clinical expertise to evolving endpoint considerations and complex trial procedures.
Register for this webinar to learn how cross-functional clinical expertise can strengthen the design and execution of glomerular disease clinical trials.
Who should attend
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
What you will learn
- Assess how evolving regulatory expectations and surrogate markers (e.g., proteinuria, eGFR slope) impact study design across glomerular indications
- Structure early collaboration among Medical Monitors, ACPs and CTMs to eliminate departmental silos and align clinical strategy with operational execution
- Deploy practical, ACP-enhanced strategies to dramatically reduce protocol deviations and ensure data integrity
- Apply cross-functional, therapeutically aligned expertise to streamline site onboarding, resolve eligibility queries faster and enhance data quality in rare disease populations
Featured Speakers
Ajay Srivastava, MD, FASN
Dr. Ajay Srivastava, MD, FASN, is Vice President, Medical Department at Medpace, bringing over 20 years of clinical, academic, and clinical development experience to the global advancement of safe and effective therapeutics. Board-certified in Internal Medicine and Nephrology with expertise in interventional nephrology, his prior leadership roles include Division Chief of Nephrology, Interim Chair of Medicine, Medical Director of dialysis facilities, and Director of the Nephrology Fellowship Program at the University of Cincinnati College of Medicine. Dr. Srivastava completed his undergraduate degree with honors at the University of Rochester, earned his MD from the University of Texas Medical Branch, and completed his residency and fellowship training at the University of Rochester Medical Center. He is a Fellow of the American Society of Nephrology.
Sudha Alphonse, MSc, RN
Ms. Sudha Alphonse holds a Master of Science in Advanced Clinical Practice from King’s College London with 15 years of clinical experience in nephrology. Prior to joining Medpace, she served as a Renal Clinical Nurse Specialist at London Bridge Hospital, HCA Healthcare, providing specialist care across acute kidney injury, chronic kidney disease, dialysis and renal transplantation. She previously served as Practice Development Nurse and Renal Sister at King’s College Hospital, reviewing patients in low clearance and post renal transplant clinics, overseeing renal nursing education and competency programs across multiple NHS units. Ms. Alphonse holds registered licenses as a Nurse, Teacher and Non-Medical Prescriber with the Nursing and Midwifery Council.
Sara Rhoten, MSN, RN
Ms. Sara Rhoten is a board-certified Family Nurse Practitioner with nearly two decades of clinical experience in nephrology. She holds a Master of Science in Nursing from Northern Kentucky University. Prior to joining Medpace, Ms. Rhoten served as a Nurse Practitioner at The Kidney and Hypertension Center in Cincinnati, providing collaborative dialysis care for patients with end-stage kidney disease, episodic CKD management and post-transplant care, including participation in transplant-related clinical research protocols. She is a member of the American Nephrology Nurses Association and the National Kidney Foundation.
Emily Berens, CCRC
Ms. Emily Berens holds a Bachelor of Science in Dietetics, Nutrition and Food Sciences from the University of Vermont. Prior to joining Medpace, she served as Clinical Project Manager at the University of Colorado Cancer Center, overseeing up to 20 investigator-initiated clinical trials and supporting multicenter management and regulatory compliance in accordance with FDA and GCP guidelines.
Partner for this event
Medpace
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.