
Our Approach
Your Partner in Clinical Excellence. Driven by Data.

Expert-Led & Inspection-Proven
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From Fragmented Data to Strategic Asset
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EMR & Analytics Optimization
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Powerful CIBMTR/NCT Dashboards

Accreditation & Audit Readiness
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Guaranteed FACT & CIBMTR Compliance
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Proven 100% Mock Audit Success
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End-to-End Quality System Design
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Expert-Led Inspection Preparedness

Clinical Program Acceleration
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CGT & CAR-T Program Onboarding
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Clinical Research Dataflow Optimization
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SOP Development & Staff Education
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Guidance by a 15+ Year Veteran MD
The Challenge.
Navigating the Complexities of Modern Therapy Programs
Whether you're starting a new CAR-T protocol, expanding to gene therapy, or preparing for your next critical inspection, the challenges are significant. We provide the strategic insight to overcome them:

Audit Pressure
Facing tight deadlines and the demand for zero critical findings.

Data Overload
Struggling with fragmented data from EMRs, labs, and registries.

Regulatory Hurdles
Keeping up with constantly evolving FACT, CIBMTR, and FDA standards

Resource Gaps
Lacking the specialized in-house expertise for data architecture or quality management.
Our Services.
Our Specialized Consulting Services
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Your Lead Consultant
Meet Dr. Yuliya Shestovska, MD
Clinical & Scientific Leadership
A Medical Doctor with 15+ years of specialized experience in hematology and cellular therapy, with a proven record of launching novel, patient-focused clinical programs.
Regulatory & Data-Driven Excellence
Expert in FACT, FDA, and GxP compliance, transforming complex data from EMRs (Epic, Cerner) into actionable strategies for flawless accreditation.
Recognized Industry Expertise
A recognized industry expert and founder of TCT MD, with publications and presentations at major international conferences like ASTCT, ASH, and EBMT.