Meet Our Visionary Founder
Marilyn White, Founder and Principal Consultant of Clinical Research Solution (CRS), brings over 25 years of expertise in clinical development, regulatory strategy, and operational leadership within the life sciences industry.
Her background includes key roles across global pharmaceutical companies, biotech firms, and CROs, where she led cross-functional teams through every phase of clinical research.
Driven by a passion for quality and personalized service, Marilyn founded CRS to provide small and mid-sized companies with agile, end-to-end support in clinical operations and science, regulatory writing, and quality management.
Known for her strategic clarity and practical execution, she helps clients navigate complex regulatory pathways and bring compliant, market-ready therapies to patients—efficiently and effectively.
Our Service Offerings
We offer three core service areas—each fully customizable to your project scale and budget
Quality Management & Inspection Readiness
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GXP/ICH compliance gap analyses
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SOP development & training
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Mock inspections & FDA/EMA audit coaching
Regulatory & Medical Writing
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IND, CTA & NDA, BLA dossier preparation
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Investigator Brochures, Protocols, Clinical Study Reporting
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Scientific Publication and Abstract Writing
Clinical Development & Operations
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Protocol design & feasibility assessments
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Site selection, monitoring & oversight
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End‑to‑end trial management
How We Work
A proven, collaborative approach to accelerate outcomes while staying compliant.
We meet your team to define objectives, timelines, and risk tolerances.
Clinrs builds a modular roadmap—allocating resources where you need them most.
From bridging from pre-clinical to first patient-in to final regulatory submission, we track milestones against your goals.
Post program and after key milestones, we debrief on lessons learned and refine processes for your next program.
Ready to discuss your next program?
Leave your details below, and a CRS consultant will reach out within 24 hours.