David Cronin Email & Phone Number

Throughout my life I’ve always enjoyed technical things, building things, and making something work in a new way. The majority of my career has been in helping develop and commercialize Software-as-a-Service solutions, for multiple industries, by leveraging “systems thinking” expertise to add value to a variety of different types of science and engineering related projects.I’m passionate about using “systems thinking approaches” because this provides a holistic approach that emphasizes understanding the interconnections and interactions within systems, and systems of systems. It involves viewing the system as a whole, rather than focusing on individual components in isolation. This holistic perspective helps identify patterns, optimize system performance, and anticipate potential issues by considering feedback loops, emergent behaviors, and the relationships between various system elements. It also empowers teams to maximize creating, managing, and wrangling complicated data and relationships to be readable by both humans and machines, achieving more efficient and effective product development and lifecycle management outcomes.One of my goals in being part of the Data Transformation efforts reshaping multiple industries in the 21st century is “to help companies effectively and efficiently move from source data to submission, with true structure, thereby providing the ability to manage knowledge and not simply reports."Areas of expertise include:• Systems Engineering & Systems Thinking• Structured Content and Data Management (SCDM) & Structured Content / Dossier Authoring• Structured Content and Dossier Authoring • Design and implementation of electronic Drug Stability Reporting, Criticality Analysis/Recipe, Batch Analysis, Comparability, Specification Documents, Justification of Specifications, Risk Management, etc. for BioPharma Drug Development• Experience in developing products while adhering to a variety of industry standards, including 21 CFR Part 820, ISO 13485, ISO 14971/24971, IEC 62366, ICH M4, Q9, ISO 15288Areas of interest include:• Improved e-Reporting tools for CTD/Dossier Modules, such as CTD CMC Module 3 e-Reports• Co-chair of the INCOSE (International Council On Systems Engineering) Healthcare Working Group, whose mission is to bring together systems engineers and systems thinkers to identify, develop, and tailor best practices for the Healthcare industry.• Member of Northeastern University Department of Bioengineering Industrial Advisory Board• Member: ISPE, RAPS, ASME, ASQ industry organizations

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