Children and families should not be asked to absorb the cost of a study built on avoidable assumptions.
Pediatric programs often involve rare or ultra-rare conditions, genetic disease, small patient populations, heightened ethical and safety scrutiny, and complex regulatory requirements. Feasibility, protocol design, recruitment, site support, caregiver realities, and decentralized options must work together, so every patient's data can meaningfully guide the next decision.
Every patient's data should meaningfully guide the next decision.
Why Veristat
When the eligible patient population is small, getting the design and evidence strategy right the first time becomes critical.
Veristat helps sponsors connect pediatric regulatory planning, clinical operations, biometrics, medical oversight, and submission requirements before gaps put patients, timelines, or the program's next decision at risk.
Build a pediatric development path that connects:
Strategic advice from scientific experts across all disciplines to support the planning of your pediatric clinical development program.
Operational support to advance your clinical trial to its next milestone by finding and treating the right patients.
REGULATORY CONSULTING EXPERTISE FOR PEDIATRIC TRIALS
A Regulatory Path Built Around the Required Pediatric Evidence
Pediatric development requires earlier coordination across study design, ethics, safety, iPSP or PIP commitments, agency expectations, and the evidence needed to support each next decision.
Regulatory Success, Start to Finish
Ensure regulatory success with regulatory consulting advice, marketing application support, and regulatory publishing.
Support for Adult Populations to Pediatric
If your therapies are intended to treat adult populations, our global regulatory experts can support preparing, writing, and submitting your initial Pediatric Study Plans (iPSPs) and/or Paediatric Investigation Plans (PIPs).
CASE STUDY
Global Pediatric Full-Service Phase I/II Clinical Trial Begins on Heels of Successful Natural History Study
A mid-sized biotech company sought Veristat early in development for help with a natural history trial. After its successful implementation, the sponsor moved forward with the gene therapy treatment program, which has already treated its first patients. Read how Veristat continues to provide full-service support for this Phase 1/2 clinical trial.
Read the Case Study →
40+
Full-service biologics trials successfully conducted in the past three years
From regulatory strategy and biostatistics to site management and patient relocation, Veristat served as an extension of the sponsor team to advance an ultra-rare pediatric gene therapy program.
Scientific Excellence Across Pediatric Clinical Development
Pediatric expertise cuts across therapy areas, rare and genetic diseases, and complex therapy types.
Therapy Areas
Endocrine/Metabolic, Immunology, Neurology/Psychiatry, Oncology/Hematology, and more
Rare Diseases.
ADA-SCID, Adrenoleukodystrophy, Duchenne Muscular Dystrophy, Thalassemia, and more
Genetic Diseases.
Achondroplasia, Canavan Disease, Cystic Fibrosis, X-Linked Myotubular Myopathy, and more
Complex Therapy Types.
Biologics, Cell Therapies, Gene Therapies, Vaccines, and more.
Veristat's Proven Impact
60%
of global operations team members have experience supporting pediatric clinical development
65%
Average biostatisticians years of experience (or have advanced degrees)
PROOF & RESOURCES
Real Programs, Real Outcomes
A Practical Guide for Managing Multiple Global Regulatory Pathways
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FDA Expedited Programs – What You Need to Know
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Side-by-Side Comparison: Non-Adaptive vs. Adaptive Designs in ...
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What cannot be left to chance in your pediatric program?
From iPSP and PIP planning to feasibility, trial delivery, biometrics, and submission readiness, Veristat helps sponsors build a connected evidence path for therapies intended for children.
A PIP (used in the EU) or iPSP (used in the US) is a regulatory plan required for therapies intended to treat adult populations, outlining how and when the therapy will also be studied in pediatric patients. Veristat's regulatory experts support the preparation, writing, and submission of both.
Many pediatric conditions are rare or ultra-rare diseases, genetic in nature, or life-threatening, which brings heightened regulatory, ethical, and safety scrutiny, along with smaller, harder-to-reach patient populations that require tailored feasibility, recruitment, and site management strategies.
Yes. 60% of Veristat's global operations team members have experience supporting pediatric clinical development, and 65% of global regulatory experts have experience with pediatric therapies specifically.
