pharmaDev Consulting, LLC provides hands-on, field-tested clinical research consulting services for investigative sites, independent research organizations, and emerging biotech sponsors. Every engagement is grounded in 28+ years of experience on both sides of the monitoring table — site level and CRO/Sponsor level.
Hands-on operational support for investigative sites at any stage — from startup through closeout. Every engagement is tailored to your site's specific needs, therapeutic area, and regulatory environment.
Site evaluation through the Monitoring Lens™ — identifying documentation gaps, regulatory deficiencies, and compliance risks before the monitor does. Includes mock monitoring visits, finding reports, and corrective action guidance.
Building or rebuilding the operational foundation of your site — SOPs, ISF/TMF structure, regulatory binder frameworks, and quality systems designed to withstand sponsor and FDA scrutiny.
From feasibility through site initiation — regulatory document preparation, IRB submission support, SIV preparation, and startup timeline management to get your site study-ready efficiently.
High-complexity monitoring support, site rescue, audit preparedness, and sponsor-side CRO oversight for biotech and emerging sponsors navigating Phases I–IV.
Practical, field-grounded training for site staff — from new coordinators entering the field to experienced teams preparing for audits and inspections.
Customized GCP training for CRCs, sub-investigators, and site staff. Covers ICH E6(R3) requirements, ALCOA-CCEA documentation standards, informed consent, adverse event reporting, and PI oversight obligations.
A 10-module, 36-lesson online training curriculum for Clinical Research Coordinators launching September 2026. Self-paced, Teachable-hosted, and grounded in real-world monitoring standards.
To discuss your site's specific needs, contact AArruda@pharmadevconsulting.com or visit the Contact page.