Trusted Clinical Data Management Leadership for Biotech & Small Pharma

Who We Are

Clinical Data Excellence (CDX) Consulting was founded to help research-driven organizations build strong, scalable clinical data management models without unnecessary complexity.

After more than 18 years in Clinical Data Management across biotech, pharmaceutical, and CRO environments, it became clear that many organizations, particularly emerging biotech companies and academic institutions, need experienced CDM leadership but are not always ready for large internal teams or overengineered infrastructure.

CDX was created to bridge that gap.

We specialize in right-sized clinical data strategy; designing operating models, governance structures, and data workflows that align with study complexity, growth stage, and organizational culture. Our approach strengthens data quality, consistency, and inspection readiness while preserving the flexibility essential to innovation.

Unlike large consulting firms, CDX provides direct access to senior-level expertise. Engagements are outcome-focused, collaborative, and built to deliver sustainable improvements, not temporary solutions.

From external data governance and vendor oversight to database lock strategy and operational standardization, CDX partners with clients to bring clarity, structure, and confidence to clinical data operations.

What We Bring

Right-Sized Clinical Data Strategy

CDX designs data management models that fit your organization; not the other way around. We build scalable, compliant, and sustainable CDM frameworks tailored to study complexity and growth stage, avoiding unnecessary bureaucracy while strengthening quality and governance.

Senior-Level Expertise Without the Overhead

Clients work directly with an experienced CDM leader — not layered consulting teams. CDX provides strategic insight and hands-on execution across study start-up, external data integration, and database lock.

External Data & Vendor Governance Depth

Modern trials rely heavily on labs, imaging, genomics, and specialty vendors. CDX brings deep expertise in external data operations and vendor oversight, ensuring clean integration, traceability, and inspection readiness across complex data flows.

Our Services

At CDX, we pride ourselves on providing “right-sized” clinical data management services. We can tailor our services to your specific needs.

Study Start-up CDM Support:

  • CRF design (eCRF)

  • Data Management Plan (DMP) development

  • Edit check development

  • UAT support

Inspection Readiness:

  • Documentation review

  • Process clean-up

  • Gap assessments

  • Interview Preparation

Infrastructure

Support:

  • SOP creation/review

  • Roadmap creation/implementation

  • CDM training

  • Global Library creation

  • Template creation/standardization

Ongoing Study Support:

  • Query management

  • Data cleaning oversight

  • Vendor data review (labs, EDC, imaging, etc.)

  • SAE reconciliation

  • CRO oversight for CDM activities

Database Lock Support:

  • Database lock planning

  • Final data review

  • Reconciliation

  • Audit trail review

  • Quality Control

About the Founder

Brandi D. Blount is a senior Clinical Data Management leader with over 18 years of experience supporting complex clinical development programs across biotech, pharmaceutical, and CRO environments. Her work has included rare disease and genetic research studies, where data integrity, external data coordination, and cross-functional alignment are especially critical.

Throughout her career, Brandi has led end-to-end CDM activities from study start-up through database lock, with particular depth in external data governance, vendor oversight, and operational standardization. She has supported programs involving specialized laboratory data, genomics, and other complex data streams that require thoughtful integration and rigorous quality controls.

She founded Clinical Data Excellence (CDX) Consulting to provide research-driven organizations with strategic, hands-on CDM leadership tailored to their stage of growth and study complexity. Her approach emphasizes right-sized structure, sustainable processes, and practical implementation; ensuring that data operations support innovation rather than hinder it.

Contact Us

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