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Accelerate Regulatory Submissions with Data Standards and Innovation in Cloud Workflows

Streamlining regulatory submissions using global data standards and secure cloud collaboration platforms and workflows.
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Global Regulatory Data Standards

Decision Analytics can assist organizations streamline regulatory submissions, implement global data standards, and leverage cloud-based platforms to enhance data quality—backed by extensive industry experience and FDA expertise.

Expertise Driven by Experience

Led by Ron Fitzmartin, a recognized leader in regulatory science and pharmaceuticals with over 25 years of hands-on expertise in clinical research and data standards strategy, we collaborate with pharmaceutical sponsors, government agencies, and standards organizations. Our mission is to optimize complex regulatory processes, driving efficiency and delivering impactful results.

Regulatory Science and Policy Innovation

  • Guidance Development: Ron played an important role in writing the FDA’s foundational 745A(a) binding guidances, including the 745A(a) FDASIA and the standardized study data guidance, and contributed to numerous others.
  • Electronic Source Data Capture: Led the development of FDA’s electronic source data capture guidance.
  • Global Identifier Standards: Led the IDMP guidance initiative that recommended a worldwide framework for maintaining substance and dose form identifiers.
  • ICH M11 Clinical Protocol Template: Led the Expert Working Group as Rapporteur – developing the clinical protocol template, guideline, and technical specification.
  • PrecisionFDA Leadership: Served as Principal Investigator for FDA’s PDUFA VII PRISM M11 demonstration use case on the PrecisionFDA cloud platform, enabling collaborative sponsor-regulator reviews and showcasing the power of data-driven protocols.

Global Collaboration and Leadership

  • Global IDMP Working Group: Co-chaired alongside European Medicines Agency and Uppsala Monitoring Centre, directing pilot projects and authoring comprehensive reports on global standards adoption for pharmacovigilance, drug shortage mitigation, and cross-border healthcare.
  • ISO IDMP Standards Revision: As an ISO delegate, co-chaired the revision of the ISO 11616 IDMP standard for pharmaceutical product identification.
  • Team Leadership: Developed and led multidisciplinary teams at the FDA and across the pharmaceutical industry to establish enterprise clinical data standards.

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Consulting and Regulatory Expertise

Founder of Decision Analytics LLC
Ron provided consulting services in biomedical informatics, clinical trial analytics, and regulatory compliance to optimize workflows and submissions.
Senior Regulatory Roles at FDA
Ron was a Senior Advisor at FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, developing global initiatives, policy and strategy for electronic regulatory submissions and global data standards implementation.
Leadership in Biostatistics and Data Management
Ron held executive positions at Daiichi Medical Research, Daiichi Sankyo, and Purdue Pharma, overseeing biostatistics, data management, and enterprise informatics across global therapeutic programs.

Our Collaborative Approach and Lasting Impact

Decision Analytics has the demonstrated skills and experience to bring together sponsors, regulators, and standards organizations to tackle complex challenges. We can drive significant improvements in the regulatory landscape by designing, deploying and evaluating innovative cloud-based submission use cases.

Key achievements

Enhanced Data Quality
Elevated standards through study data requirements, ensuring data reliability and consistency.
Streamlined Review Cycles
Demonstrated potential for reduced review times with machine-readable protocols.
Global IDMP Implementation and Use
Established a global team to build a robust IDMP framework to address pharmacovigilance and to mitigate drug shortages.
Translating regulatory requirements into technology-driven workflows, Ron helps organizations navigate policy changes, optimize collaborative reviews, and accelerate submissions.