Resources

A structured starting point for organizations that want a clearer, evidence-based view of how their clinical research operations actually function.

The Aster & Axiom Clinical Research Operations Health Check & Improvement Toolkit combines a practical 30-page workbook with a 16-sheet Microsoft Excel companion tool. Together, they help research teams examine current operations, document available evidence, identify uncertain or inconsistent controls, prioritize operational risks, and define improvement work.

Begin with the 54-item Health Check. Record current ratings alongside direct, indirect, unverified, or conflicting evidence. The companion spreadsheet organizes the responses and identifies patterns that may deserve closer examination. It does not convert screening scores into regulatory findings or claims of compliance.

The toolkit then guides your team through a complete improvement pathway:

• Health Check and signal review
• Problem definition
• Current-state process mapping
• Root-cause hypothesis verification
• Risk prioritization
• Project scope
• Work breakdown structure
• Budget development
• PDSA testing
• Control planning

You will also receive an Expert Gates worksheet that identifies decisions requiring qualified judgment and a Consultation Brief that organizes your priorities, evidence gaps, and requested support for a focused discussion with Aster & Axiom.

Use this toolkit to:

• Examine how work is performed, evidenced, and controlled
• Distinguish documented practice from assumption
• Identify recurring issues and weakly supported conclusions
• Preserve material disagreement for further investigation
• Focus improvement work on a manageable number of priorities
• Translate concerns into defined, testable, and budgeted action
• Prepare for a more productive internal or consultant-led review

Included in your download:

• Clinical Research Operations Health Check & Improvement Workbook, PDF
• Microsoft Excel Companion Tool, XLSX
• 54-item organizational Health Check
• Automated signal summary
• Diagnostic and improvement-planning worksheets
• Expert-review gates
• Source register
• Consultation Brief

Designed for:

Sponsors, CROs, academic medical centers, hospitals, research institutes, research networks, coordinating centers, clinical research sites, and the operations, quality, regulatory, and program leaders responsible for their performance.

Important limitation

This toolkit is a structured, evidence-informed self-assessment. It is not a regulatory audit, compliance determination, validated psychometric instrument, causal proof, certification, or substitute for qualified legal, regulatory, clinical, privacy, cybersecurity, or quality judgment. A numerical result does not establish a regulatory finding or prove root cause.

If a time-sensitive concern may affect participant rights, safety, welfare, consent, eligibility, investigational product, safety reporting, or critical data, follow your organization’s authorized escalation and containment procedures immediately.

Price: $0.00



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