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.
Legacy tools and processes no longer support the business objectives for pharma. The only way to meet the growing demands for more content, faster, is to adopt a structured content ecosystem.
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 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.