| Implementation of a Cloud-Based Electronic Laboratory Notebook to Foster Professional Engineering Workforce Skills | Biomedical Engineering Education | |
| Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency | Therapeutic Innovation and Regulatory Science | |
| Early-stage Alzheimer disease: getting trial-ready. | Nature Reviews Neurology | 2022 |
| Proceedings: PET Drugs: A Workshop on Inspections Management and Regulatory Considerations. | Journal of Nuclear Medicine | 2022 |
| Clinical Trials: Ensuring Quality and Standardization | Success in Academic Surgery | 2020 |
| Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion | Digital Threats Research and Practice | |
| Good Data Recording Practices Applicable to Man and Machine | | 2017 |
| Kosten-Nutzen-Analyse und Aspekte der Ergebnisqualität von eSource in der klinischen Forschung | | 2017 |
| Clinical Audit and Practice Accreditation | | 2014 |
| Data Protection and Data Security Regarding Grid Computing in Biomedical Research | | 2012 |
| Databases and Data Management for Robotic Surgery | | 2011 |
| Data Protection and Data Security Regarding Grid Computing in Biomedical Research | | 2009 |
| Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data | PLoS ONE | 2011 |
| Next-Generation Single-Use Bioreactor Technology and the Future of Biomanufacturing: A Summary from the Manufacturer's and User's Perspective | | |
| Analytical scientist in pharmaceutical company: My thirty years in analytical R&D | Journal of Pharmaceutical and Biomedical Analysis | 2021 |
| Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development | Therapeutic Innovation and Regulatory Science | 2021 |
| 2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos) | Bioanalysis | 2021 |
| Patient-Reported Outcomes in Oncology Clinical Trials: Stakeholder Perspectives from the Accelerating Anticancer Agent Development and Validation Workshop 2019 | Oncologist | 2020 |
| The Use of Electronic Consent for COVID-19 Clinical Trials: Lessons for Emergency Care Research During a Pandemic and Beyond | Academic Emergency Medicine | 2020 |
| Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations | Journal of Pain | 2020 |
| Toxicologic Pathology Forum*: Opinion on Integrating Innovative Digital Pathology Tools in the Regulatory Framework | Toxicologic Pathology | 2019 |
| A management system for randomized clinical trials: A novel way to supply medication | PLoS ONE | 2019 |
| Data Management in Clinical Trials | | 2018 |
| Quality by Design in Practice | | 2018 |
| Artificial intelligence based clinical data management systems: A review | Informatics in Medicine Unlocked | 2017 |
| [Centralized biobanks: a basis for medical research] | Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | 2016 |
| Tips for a Successful FDA Inspection | | 2016 |
| Smart Documentation Strategies | | 2016 |
| Optimizing the Use of Electronic Data Sources in Clinical Trials: The Landscape, Part 1 | Therapeutic Innovation and Regulatory Science | 2016 |
| "Bring Your Own Device" (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials? | Therapeutic Innovation and Regulatory Science | 2015 |
| HPLC im Reglementierten Bereich | | 2014 |
| The Planning, Conduct, and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations | | 2014 |
| Data Standards | | 2014 |
| An Exploratory Study on the Policies of Health Care Institutions in the New England Region of the United States Regarding Third-Party Access to Medical Records of Research Participants: Potential Effects on the Legal and Ethical Conduct of Clinical Trials | Therapeutic Innovation and Regulatory Science | 2013 |
| The Epilepsy Phenome/Genome Project (EPGP) informatics platform | International Journal of Medical Informatics | 2013 |
| Regulatory Inspection Trends and Findings of Bioanalytical Laboratories | | 2013 |
| Using Evernote as an electronic lab notebook in a translational science laboratory | Journal of the Association for Laboratory Automation | 2013 |
| Basic concepts in population modeling, simulation, and model-based drug development | CPT: Pharmacometrics and Systems Pharmacology | 2012 |
| Digital images are data: and should be treated as such | Methods in Molecular Biology | 2013 |
| Adaptation of a web-based, open source electronic medical record system platform to support a large study of tuberculosis epidemiology | BMC Medical Informatics and Decision Making | 2012 |
| The world health organization multicountry survey on maternal and newborn health: study protocol | BMC Health Services Research | 2011 |
| Security Stripes: Visible Seals for Robust Documentation and Authentication of Digital Images | Microscopy Today | 2010 |
| Data Standards | | 2008 |
