Experienced Clinical Operations Leadership — Without the Full-Time Overhead
Validate Clinical provides fractional clinical operations, regulatory documentation, and protocol writing support to early-stage biotech, pharmaceutical, and medical device companies that need senior-level expertise precisely when they need it.
Built for Organizations That Can’t Afford to Get It Wrong
Early-stage biotech and medical device companies face the same challenge: you need experienced clinical operations leadership, but you're not yet at the stage where a full-time hire makes sense.
Validate Clinical was built for exactly this moment. We step in as a trusted operational partner — bringing 15+ years of FDA-regulated clinical research experience to your program, without adding permanent overhead to your organization.
We work with:
Biotech and pharmaceutical sponsors in Phase I–IV development
Medical device and IVD companies navigating FDA requirements
Research organizations and academic medical centers needing contract support
Organizations preparing for inspections or audits
Senior Experience. Boutique Attention.
Validate Clinical is led by Tiffany Dawn Jones, ACRP-PM®, CCRA®, a clinical research professional with 15+ years of hands-on experience spanning global pharmaceutical trials, medical device IDE studies, diagnostic programs, and oncology research at institutions including UCSF, Roche Molecular Systems, Talis Biomedical, and iRhythm Technologies.
When you work with Validate Clinical, you work directly with Tiffany. No handoffs to junior staff. No learning curve. Just experienced, focused support from someone who has done this work at every level — from site coordinator to senior CRA to program consultant.
How We Can Help
Protocol & Informed Consent Writing
Clear, compliant, and inspection-ready study documentation
Clinical Program & Project Management
End-to-end oversight across Phase I–IV trials
Regulatory Documentation & SOP Development
Structured documentation that holds up under scrutiny
Study Start-Up & Site Activation
Organized, efficient activation to get your program moving
Clinical Monitoring & Site Management
Quality oversight that protects your data and your timeline.
Medical & Regulatory Editing & Proofreading
Precise review of clinical and regulatory materials for accuracy and compliance.
What Tiffany Dawn Brings to Your Program
15+ years in FDA-regulated clinical research environments
Experience across pharma, biotech, medical device, and IVD
Active ACRP-PM® and CCRA® certifications
Background spanning site-side coordination and sponsor-side CRA/ClinOps
Therapeutic areas: oncology, neurology, cardiology, diagnostics, medical devices
Global trial experience across 16 countries and 274 investigative sites
BA, English Literature — UCLA (strong writing foundation in every deliverable)