The Company Core Data Sheet (CDS or CCDS) is one of the most important documents a pharmaceutical company creates. The CDS is a working document that contains information about the pharmaceutical product. It includes information from multiple sources, such as clinical trial data systems, clinical report documents, CMC data systems,
After decades (literally) of talking about silos, calmly and not so calmly explaining to people why they are problematic, and advocating for their demise, I have come to the (obvious) conclusion that we are not going to eliminate them any time soon. If you already figured this out, you are
We talk a lot about the goal of enterprise content strategy for pharma: to help speed up the process of making safe, effective medicines.
“We cannot change the authoring experience.” This, more than anything else, is the message we used to be told (and still hear often) when we suggest a component-based structured authoring environment for medical writers at pharmaceutical companies. The authoring experience using Microsoft Word reigns supreme. Any changes to this interface
The pharma industry is no stranger to standards. Pharmaceutical companies have entire teams devoted to ensuring that all data and content is collected, created, managed, retained, and retired according to regulatory requirements.
Vigilante content is all the content created (and often distributed) by people who are not tasked with creating content. It’s the content that someone thinks up and then writes. And then publishes or emails or prints to hand out at a conference. In essence, it is unauthorized content.
Using component-based structured content authoring and having a robust reuse strategy is the only way to produce pharma content at scale. It’s how you produce accurate content efficiently across the enterprise. It’s how you deliver the right content to the right place at the right time, such as when you
The pharma industry has come together to develop technical solutions that speed time-consuming processes and reduce errors that can cause risk to the business and ultimately to patients.
We can no longer afford the costs of traditional, document-based content management in the pharmaceutical industry. We need pharma companies to prioritize content reuse and automation rather than manual, error-prone legacy processes.
In January 2022, I received my Year in Review video from WW (formerly Weight Watchers). The video showed me some fun stats about my participation in the program in 2021.