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GCP Quality Assurance:

Risk Based

Data Driven

Operationally Aware

Quality Systems
  • Quality Management System design and development

  • "Lean SOP" development

  • SOP gap assessments

  • Veeva QualityVault and QMS implementation

  • Quality, fraud, and scientific misconduct investigations

Audits and Inspections
  • Qualification, in-process, and for-cause audits

  • Computerized system audits and 21 CFR Part 11 assessment

  • Inspection planning

  • Mock inspections

  • Storyboards

  • Inspection coaching

  • Situation room facilitation


Quality Management
  • ICH E6 R2 quality risk management process implementation

  • Quality, risk, and performance metrics design, development, and reporting

  • Risk-based audit selection

  • Risk-based monitoring support


Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations.  Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development.  She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.

A syncline is a geological structure of folded, stratified rock. “Synclinical” is a play upon that term that emphasizes the collaborative, synergistic nature of clinical development.



7 Pond Street

Newburyport, MA  01950

(978) 880-3242

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