In pharmaceutical and biotech regulatory document development, your content strategy – the business plan for how you create, manage, and deliver content – significantly impacts your ability to innovate, comply with regulations, and ultimately, bring new medicines to market. It’s understandable to think that the pharma industry can take a
There are many reasons why a component structured content management (SCM) system is superior to using a Microsoft Word document for managing your Company Core Data Sheet (CDS or CCDS). We touched upon some of the reasons in our previous blog post, The CDS is Dead! Long Live the CDS!
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,
We talk a lot about the goal of enterprise content strategy for pharma: to help speed up the process of making safe, effective medicines. One part of achieving that goal is to get content through regulatory approval faster. To speed up review and approval, pharma content must be: Easy to
“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. Many of those legal requirements have associated standards to help everyone manage characteristics such as: Terminology Data formats
Buy this Book to learn exactly what it takes to deliver personalized experiences at scale.
Get exclusive access to Val’s thoughts and hand-picked content with our newsletter.
“*” indicates required fields