On September 8, 2025, the U.S. Food and Drug Administration (FDA) posted the final version of E6(R3) Good Clinical Practice (GCP) on its website and ...

Clarkston Consulting recently partnered with a CDMO on a LabVantage LIMS implementation dashboard assessment. Read a synopsis of the project ...

In January 2025, the FDA banned synthetic food dye Red No. 3 under the Delaney Clause due to concerns over health risks. The food and ...

Today, life sciences firms are facing increased regulatory complexity, huge volumes of data, and increased pressure to bring safe therapies ...

Selecting an Electronic Quality Management System (eQMS) is one of the most important technology decisions a life sciences organization can ...

Steve Jobs said in 2003 in reference to his business model, “Great things in business are never done by one ...

As digital transformation continues to reshape laboratory operations, Electronic Lab Notebooks (ELNs) have become a critical role in laboratory informatics. ...

Below, our Veeva experts provide their perspective on insights from the 2025 Veeva MedTech Postmarket Quality Benchmark Report.  The medtech ...

When the time comes for a clinical organization to select a new Laboratory Information System (LIS), it may be challenging ...

Last week, a number of Clarkston’s life sciences experts attended the 2025 Veeva R&D and Quality Summit in Boston, Massachusetts. This ...

In this TraceLink implementation case study, Clarkston Consulting recently partnered with a pre-commercial biopharma company on a serialization strategy. Read ...

Clarkston Consulting recently partnered with a biopharma company on a implementing a global Veeva Vault QMS. Read a synopsis of ...