Services
Everything the clinical research process actually requires.
Site operations sit at the center. Monitoring, medical writing, regulatory submissions, pharmacovigilance, data management, and equipment acquisition sit with them. If it is part of running the trial, it is in scope.
The spine
Four stages. One standard.
01
Feasibility
Protocol fit, enrollment realism, competing trials, and whether the site can actually run the visit schedule — before anyone wastes a startup cycle.
02
Startup
Regulatory packets, essential documents, equipment acquisition, vendor setup, and training so first-patient-in is an operational fact, not a slide.
03
Execution
Day-to-day site operations, monitoring, data flow, deviation handling, and the unglamorous work that keeps a Phase 2 or 3 from drifting.
04
Closeout
ISF reconciliation, query resolution, investigational product accountability, and a close that will stand up to a monitor, an auditor, or an inspector.
Capabilities
A full clinical-process bench, sized to a boutique practice.
Site operations
Feasibility & site selection support
Candid assessments of protocol-site fit, enrollment, and operational risk.
Startup & activation
Essential documents, IRB/ethics packets, contracts coordination, and activation checklists.
Trial execution
Visit flow, source, investigational product, and the daily conduct of Phases 1–4.
Closeout
File completeness, IP return/destruction, and inspection-ready archives.
Equipment acquisition
Sourcing, qualification, and setup of the hardware a protocol actually requires.
Clinical conduct
Monitoring
On-site and remote monitoring with a site-ops lens — findings that are actionable, not theatrical.
GCP & staff training
Protocol-specific training grounded in how visits actually run, not generic slide decks.
Regulatory & safety
Regulatory submissions
Support for the packets and correspondence that keep a study legally and ethically live.
Pharmacovigilance
Safety reporting workflows, SAE coordination, and the discipline to file on time.
Scientific & data
Medical writing
Protocols, ICFs, narratives, and study documents written in plain clinical English.
Data management
eCRF readiness, query hygiene, and the site-side habits that keep a database clean.
Advanced protocol operations
Gene therapy, first-in-human, and other protocols that do not behave like a standard Phase 3 — chain of identity, specialized handling, and visit architectures that have to hold.
How we engage
Fractional, study-by-study, or a defined operational lane.
Some sponsors need a full site-ops partner. Some CROs need overflow on a single protocol. Some sites need startup and equipment without hiring a department. The model flexes; the standard does not.
Discuss a protocol