Goodwater Pediatric Trials provides pediatric drug development consulting to biopharma, investors and patient organizations. We combine clinical experience in pediatric care with industry experience leading pediatric programs, and we deliver the work itself, from pediatric study plans to trial strategy.
Small trials,
big impact.
Pediatric trials are often small: one study, a limited number of children. Designed well, that one trial can meet pediatric regulatory requirements, earn added exclusivity and support the value of the entire asset. Pediatrics is where the ripple starts.
One trial, many ripplesA well-designed pediatric trial creates value for children, families and sponsors alike. Select any ring to see how far it reaches.
Select your organization type to see how we typically support teams like yours.
As adult development advances, pediatric obligations follow. For sponsors and CRO partners, we provide pediatric expertise and the documents that support it.
Pediatric obligations and opportunities can affect the value of an asset. We provide a clear, timely assessment to inform investment decisions.
Patient organizations and foundations are increasingly advancing therapies themselves. We provide the regulatory and development expertise to support that work.
Experience caring for children and families informs designs that are feasible for sites and families.
Familiarity with the development and regulatory requirements needed to bring a medicine to children.
We prepare pediatric study plans, PIPs and strategy documents, rather than only reviewing them.
Families, advocates, investigators, vendors and regulators, aligned around a shared plan.
Defined deliverables for your development team, leadership or regulators.
Timing, age cohorts, extrapolation and sequencing alongside your adult program.
Drafted, refined and ready for submission after your End-of-Phase 2 meeting.
Built to the EU template, with deferral and waiver strategy where they apply.
Proposed pediatric studies positioned for added exclusivity.
Endpoints, dosing, blood volumes, visit burden and assent, reviewed by a pediatric clinician.
Patient availability, site capability and the support sites will need to enroll.
Briefing documents and preparation for FDA and EMA discussions, with pediatric expertise in the room at your agency meetings, advisory boards and scientific conferences.
Obligations, risks and opportunities in a pediatric program, clearly summarized.
Pediatric nephrology clinical trials are our flagship. Our approach to small population clinical trials reaches across pediatrics.
Founder & President
Dr. McKenzie brings both clinical and industry perspectives to pediatric drug development. Double board certified in pediatric nephrology and general pediatrics, she practiced as both a pediatric nephrologist and a pediatric hospitalist. In industry she was a clinical development lead at GSK, and at Boehringer Ingelheim she led several successful clinical trials, including the pediatric EMPA-KIDNEY Kids trial.
“Jen from Goodwater understands clinical development from every angle: the clinician’s, the trial’s and the regulator’s. She also has a deep connection to the patient experience. She is a tremendous asset to this community and cares deeply about bringing new therapies to patients.”
Vincent KoFounder & Executive Director, KidneyFuture (formerly CAKUT Foundation)Invited talks and recent publications on pediatric trial design, endpoints and regulatory pathways.
Voice of the Clinical Trial Village: Recruitment & Execution
U.S. Pediatric Research Requirements & the Path to Feasible, High-Value Studies
Fireside Chat: Pediatric Rare Disease Development
Clinical Trial Design Considerations for Small Populations in Rare Kidney Disease
What Outcomes Matter to Patients? Rethinking Endpoints in Kidney Therapies
CAKUT: Laying the Groundwork for Trials
Share where your program stands, and we will follow up to discuss how Goodwater can support it.