Built From the Inside Out.
J&S Scientific Solutions was founded on a simple belief: the best consulting comes from people who have actually done the work.
Nyle J. Leiva, BS, M-BME
Founder & Principal Consultant, J&S Scientific Solutions
Nyle J. Leiva brings over 16 years of direct, hands-on experience in clinical research to every engagement at J&S Scientific Solutions. He has worked at every level of the research ecosystem — from site staff to site director, from day-to-day operations to high-stakes FDA inspections — giving him a perspective that most consultants simply do not have.
Before founding J&S, Nyle served as a Site Director where he managed the full operational, regulatory, and sponsor-facing responsibilities of a clinical research site. He has personally written CAPA responses, navigated FDA inspections, managed sponsor and CRO relationships, launched new studies from protocol through first patient, and kept complex operations running under pressure.
That experience is what J&S was built on. Clients don't get a junior consultant reading from a checklist — they get Nyle, applying 16 years of real-world knowledge to their specific situation.
CREDENTIAL HIGHLIGHTS
Biology, BioMedical Engineering and Medical background
16+ years in clinical research operations
Site Director experience across multiple therapeutic areas
FDA inspection management and CAPA development
Phase I–IV trial experience
Bilingual: English and Spanish
Why J&S Exists
Clinical research is full of consulting firms that have never actually run a site. They advise from a distance. They send junior staff. They add layers between the client and the expertise.
J&S was built as the alternative. A lean, senior-level practice where every client relationship is handled with the same care and accountability that Nyle brought to every site he ran. No bloated overhead. No bureaucracy. Just experienced, practical support for the people doing the hardest work in medicine.
Headquartered in Miami, Florida, J&S serves clients across all 50 states and is actively growing its presence in Latin America — a region with enormous potential for clinical research expansion and an underserved need for experienced operational support.
How J&S Works
Discovery Call
We start by understanding your situation — your goals, your challenges, and what success looks like for you. No sales pitch. Just a direct conversation.
Assessment
We assess the situation and develop a clear plan. Whether it's a regulatory remediation roadmap, a study placement match, or an operational support structure, you'll know exactly what we're going to do and why.
Execution
We get to work. Nyle leads every engagement personally, drawing on a trusted network of clinical research professionals to deliver what's needed — at the speed the situation demands.
Ongoing Partnership
Many J&S clients work with us across multiple engagements. As your organization grows and evolves, we grow with you — always available, always senior-level.
Wherever You Are, We're There.
J&S is headquartered in Miami, Florida — one of the most active clinical research markets in the country. But geography is never a barrier to what we can deliver.
We serve sponsors, CROs, and research sites across the United States, and we are actively expanding our presence throughout Latin America — a region with growing research activity and a significant need for the kind of senior-level operational support J&S provides.