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
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. The goals of these technical solutions include: Facilitate digital information exchange between CROs, sites, sponsors, regulators, and EHR systems Guide decisions at
In The Unique Challenges of Pharma Content, we discuss challenges faced by pharmaceutical companies in the creation and management of content. Here is a short list: Takes too long to create, approve, and deliver content Cannot leverage or reuse content across documents and organizational silos Cannot manage the high volume
I recently came across a great commentary in the August 2021 issue of “Pharma Technology Focus.” The article is titled, “MDR set to transform how MedTech firms approach content management,” written by Barbara Peraltor, Director of Life Science Solutions at Amplexor. Barbara makes a number of pertinent points in the
I’ve had more than one conversation over the past several years about whether pharmaceutical companies were “ready” for structured content. After all, many of the benefits of structured content roll up into one key business need: scale. And scale — the ability to produce a lot of content quickly, accurately,
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