Blog Post Quality + Compliance Data + Analytics Leveraging AI and ML in Lab Informatics: The Future of Lab Innovation Along with many other industries these days, biotech companies are rapidly changing the way they do business by leveraging the ...
Blog Post Quality + Compliance People + Change Preparing for a GxP Commercial Launch: What Do Quality Leaders Need to Know? As your company eagerly awaits the results of its Phase 2 trials, all signs point to success. This milestone has ...
Multimedia Life Sciences Quality + Compliance 2025 Quality and Compliance Trends Clarkston’s team of life sciences consultants have highlighted the top quality and compliance trends that businesses should consider. See an ...
Case Study Life Sciences Quality + Compliance Conducting an LIS Vendor Selection for a Diagnostics Company A diagnostics company called in Clarkston Consulting for support in conducting an LIS vendor selection. Read a synopsis of the ...
Multimedia Life Sciences Quality + Compliance 2025 Lab Informatics Trends Clarkston’s team of quality and compliance consultants have highlighted the top lab informatics trends that businesses should consider. See an ...
Blog Post Life Sciences Quality + Compliance Ensuring GxP Commercial Launch Readiness: Key Considerations for Quality Leaders For late-stage biotech and biopharma organizations, ensuring GxP commercial launch readiness is critical to achieving success, and there are key ...
Blog Post Life Sciences Medical Device Understanding Recent FDA Guidance on Firm to HCP Communications: Questions & Answers On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Quality + Compliance Medical Device What You Need to Know About Recent FDA Guidance on Firm-to-HCP Communications Regarding SIUU On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Life Sciences Quality + Compliance LIS vs. LIMS: What’s the Difference? Laboratory Information Systems (LIS) and Laboratory Information Management Systems (LIMS) serve important purposes in laboratories. The foundational difference between LIS ...
Blog Post Life Sciences Quality + Compliance Evaluating SDMS Vendors: How to Find the Best Platform for Your Life Sciences Organization As companies look to stay competitive and efficient, they’re increasingly turning to sophisticated technologies that support these goals, like SDMS. ...
Multimedia Quality + Compliance Life Sciences Ensuring a Successful QDMS Implementation and Data Migration A well-structured assessment phase and data migration plan is essential for a successful QDMS implementation and data migration. Following the ...
Case Study Life Sciences Quality + Compliance Implementing LabVantage LIMS for a Seamless TSA Exit Strategy for a Biopharmaceutical CDMO Clarkston Consulting recently partnered with a Contract Development and Manufacturing Organization (CDMO) client on a LIMS and TSA exit strategy. ...
