Estrada Clinical Consulting helps community hospitals and startup biotech organizations stand up compliant, sponsor-ready clinical trial programs — from the ground up.
Schedule a discovery call →I work with organizations that have the ambition to run clinical trials but need experienced operational leadership to build the foundation properly — before sponsors, monitors, or auditors show up.
You want to attract industry-sponsored trials but don't have the infrastructure, SOPs, or staff training to compete. I help you build a program that sponsors will want to work with — and that your team can run confidently.
You've filed your IND and you're ready to activate sites — but you need operational expertise without the overhead of a full-time hire. I bring sponsor-side clinical operations leadership on a flexible, project basis.
You're running a handful of trials and want to grow — but every new study reveals gaps in your processes. I help you build the systems, SOPs, and staff capabilities to scale without losing quality or compliance.
Monitoring findings, a sponsor audit on the horizon, or a pattern of protocol deviations — I conduct a rapid operational assessment and put a corrective action plan in place before it becomes a bigger problem.
Every engagement starts with understanding where you are. From there, we build what you need — nothing more, nothing less.
A structured 2–3 week review of your current research infrastructure. I assess your SOPs, regulatory documentation, CTMS setup, staffing, and sponsor-readiness — and deliver a written report with a prioritized action plan.
Monthly consulting support for sites building or scaling their research program. I work alongside your team to strengthen operations, train staff, and keep your studies on track.
A customized set of 10–15 trial-ready standard operating procedures built specifically for your organization — from protocol deviation management to adverse event reporting and TMF maintenance.
I've spent 15 years running clinical trials from the inside — building the infrastructure, training the teams, and delivering the enrollment and quality targets that sponsors depend on. I've worked across Phase I through IV oncology trials spanning 12+ cancer types, as well as critical care, stroke, and cardiology.
Throughout my career I've served as the operational bridge between research sites and the pharma and CRO partners on the other side of the table. I've negotiated budgets directly with sponsors, directed CRO performance, managed TMF compliance, and stood up trial programs from scratch — including the infrastructure that supported the first patient in the world to receive Remdesivir in COVID-19 ICU trials sponsored by Gilead Sciences.
I founded Estrada Clinical Consulting because I kept seeing the same problem: organizations with real research ambitions held back by gaps in infrastructure, compliance, or operational know-how. I know how to fix those gaps — and I know how to do it in a way that sponsors, monitors, and auditors will respect.
If you're building something, or trying to fix something, I'd love to talk.
Every engagement starts with a 20-minute discovery call. No obligation — just a conversation about where you are and where you want to go.
silvia@estradaclinical.com