WHO WE SERVE
Sponsors & Pharma/Biotech
We support Phase I–IV trials with site identification, oversight, and regulatory strategy so your studies stay on track and inspection-ready.
Contract Research Organizations (CROs)
We act as an extension of your team — providing senior-level operational and regulatory support without the cost of a full-time hire.
Clinical Research Sites
We bring you studies, fix compliance gaps, and step in operationally when you need experienced leadership fast.
Scientific Solutions?
Most consulting firms give you a team you never meet, managing problems they've never personally solved. J&S is different.
Nyle J. Leiva, Founder and CEO, has spent 16+ years working inside clinical research — as a site director, regulatory specialist, and operational fixer. He has sat across from FDA inspectors, written CAPAs under pressure, managed sponsor relationships, launched sites from scratch, and turned around operations that were on the verge of collapse.
When you work with J&S, you work with that experience directly. No layers. No junior staff handed your file. No big-firm overhead passed on to you.
Based in Miami, Florida, J&S serves clients across the United States and is actively expanding throughout Latin America. Geography is never a limitation.
"16+ years. Regulatory. Operational. Sponsor-facing. Site-facing. FDA-fluent."
Phase I–IV
Full Trial Lifecycle Coverage
Our Services
Connecting the right study to the right site.
J&S works directly with sponsors and CROs to identify and qualify research sites for active clinical trials. We handle feasibility, match the right study to the right site based on therapeutic area and capacity, and support the relationship from placement through startup. For sites, this means revenue-generating studies without building your own BD team.
Best for: Sponsors, CROs, and independent research sites
FDA-fluent. Built from real-world experience.
FDA inspection preparation, 483 response letters, CAPA development and implementation, IRB submissions and closures, regulatory document review and remediation. Nyle has managed these challenges from inside a real site — under real pressure, with real consequences. He knows what an FDA inspector looks for because he's sat across from one.
Best for: Sites facing audits, 483s, warning letters, or regulatory remediation
Get from protocol to first patient faster.
Protocol review and feasibility assessment, site initiation preparation, delegation of authority and staff training, SOP development, budget and contract support. J&S can take a site from study awarded to study open more efficiently than most sites can do it on their own.
Best for: Sites adding new studies, new therapeutic areas, or new sponsor relationships
Senior-level leadership when you need it most.
When a site is short-staffed, going through a transition, or dealing with a quality crisis, J&S can step in as an experienced Site Director or operational consultant. We have run full sites, managed staff, coordinated with sponsors, handled budgets, and kept studies compliant under difficult conditions. We don't just advise — we execute.
Best for: Sites in transition, growth mode, or operational crisis
Build the study pipeline your site deserves.
Beyond placing individual studies, J&S helps sites think strategically about which therapeutic areas to pursue, which sponsors to target, and how to position themselves to attract and retain more studies. If you're ready to grow, we can help you build the infrastructure to support it.
Best for: Site owners and site networks looking to scale
Not sure which service fits your situation?
16+ years. Regulatory. Operational. Sponsor-facing. Site-facing. FDA-fluent.
What's your biggest challenge right now?
Whether you're a sponsor dealing with site performance issues, a CRO looking for operational backup, or a site trying to grow your study portfolio J&S has the experience to help. Reach out for a no-obligation consultation.