Category: Blog

Achieving Content Compliance Success in Life Sciences

I was pleased to be a guest speaker at the third episode of Quark’s “Close the Content Loop” webinar series, called How Do Life Sciences Companies Keep Content Compliant?, where we discussed the importance of content compliance among life sciences organizations. When talking about content management for content compliance in the life sciences industry, we’re […]

Written by on November 16, 2022

Changing Change Management – How to Ace Change Initiatives in Pharma

TL;DR Enterprise IT projects can generally be broken into two groups: 1. daily run-of-the-business – IT operations and infrastructure activities and 2. change initiatives. On average, two-thirds of overall enterprise IT spending goes towards infrastructure and operation. A clear and coherent change agenda will reduce waste by eliminating failed, delayed, and misaligned projects. Shifting investments […]

Written by on June 22, 2022

Pharma’s SmPC Low Hanging Fruit – SmPC Patient Safety Impact

TL;DR SmPC is a legal document used by healthcare professionals that provides information on the drug including the set dosage and other key information. Even with strict regulation with rigorous guidelines and structure for the information contained in SmPC, too often information has been found incomplete.  Major gaps have been discovered in the information on […]

Written by on June 8, 2022

Data – Achieve FAIR Principles Fast

Overview Living in an environment that is fully FAIR means you spend less time on tedious tasks. When your data hits the Findable principle, it’s like doing a Google search and the results you are presented with are exactly what you want. Because data in life sciences companies can exist across many tools, systems and […]

Written by on May 31, 2022

What is Structured vs. Unstructured Data?

What is Structured vs. Unstructured Data? TL;DR Structured data is predefined, in a set format that can be easily searched by machines.  Unstructured data is undefined and can be in various formats like text, images, audio, and video files.  Unstructured data makes up 80% of data. 63-70% of enterprise data goes unused. Natural Language Processing […]

Written by on May 25, 2022

Summary of product characteristics (SmPC) – Detecting and Managing Updates in SmPC

TL;DR SmPC is a Summary of Product Characteristics, it is the main structure for explaining pharmaceutical products’ characteristics in the EU. SmPC is a legal document used by healthcare professionals that provides information on the drug including the set dosage and other key information. Due to the volume of label changes per year (tens of […]

Written by on May 3, 2022

What is Structured Product Labeling?

TL;DR Structured Product Labeling (SPL) is the FDA’s approved standard for communicating product and quality information. SPL is based on XML. If managed well, SPL is easily maintained even if there are many changes to a drugs product information. What is Structured Product Labeling? Structured Product Labeling (SPL) is the FDA’s adopted standard for communicating […]

Written by on April 22, 2022

Electronic Product Information (ePI)

TL;DR Electronic Product Information is a digital version of the printed leaflet that comes with every prescription medication. The main driver to digitize product information is increased patient safety. What is Electronic Product Information? Electronic Product Information (sometimes referred to as Electronic Product Information Leaflet) is a digital version of the printed leaflet that comes […]

Written by on April 8, 2022

ESG Value – Top 3 Ways ESG Creates Value

TL;DR Employees see ESG initiatives as experiencing “meaning” and living a more fulfilled life. Customers want to know their dollars are being spent on MORE than just a product or service. A great ESG strategy can attract/retain better talent and be a differentiator that can help land more clients, so investors look favorably on great […]

Written by on March 18, 2022