What We Do — And How We Do It.
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
Study Placement
J&S maintains active relationships with sponsors and CROs seeking qualified sites for Phase I–IV clinical trials. We manage the full placement process — from initial feasibility through site initiation — so the site can focus on what they do best: running the study.
For sponsors and CROs, we identify sites with the right patient population, PI experience, and operational infrastructure to execute your protocol successfully. We've seen too many study delays caused by mismatched site placement. We prevent that.
Regulatory & Compliance
Regulatory issues don't wait for convenient timing. Whether you're preparing for a routine FDA inspection or responding to a 483 observation, J&S provides the kind of support that only comes from experience.
Services include: FDA inspection preparation and mock audits, 483 response drafting and submission strategy, CAPA development and implementation tracking, IRB submission, amendment, and closure management, essential document review and remediation, and protocol deviation assessment and corrective action.
Site Startup
The startup phase is where many sites lose time and momentum. J&S can accelerate your path from study awarded to first patient enrolled by handling the operational complexity that most sites underestimate.
Services include: protocol feasibility and site capability assessment, site initiation visit preparation, delegation of authority log setup, staff training documentation, SOP development and gap analysis, budget negotiation support, and regulatory binder setup and review.
Operational Management
Sometimes what a site needs is not advice — it's someone to step in and run things. J&S can provide interim site director coverage, operational management during staff transitions, quality oversight during sponsor-required audits, and hands-on support for sites in growth mode.
This service is particularly valuable for sites navigating a leadership change, a rapid portfolio expansion, or a period of heightened regulatory scrutiny.
Business Development
Growing a clinical research site requires more than clinical expertise — it requires a strategic approach to sponsor relationships, therapeutic area selection, and operational positioning.
J&S helps site owners and networks assess their competitive position, identify the sponsors and CROs most aligned with their capabilities, develop outreach strategies, and build the operational infrastructure needed to support a larger study portfolio.