Pharmaceuticals / life sciences

Pharmaceuticals / life sciences

Pharma / Life Science
Pharma / Life Science

Information processes without risks and side effects

Pharmaceuticals, life sciences and medical technology are among the most highly regulated industries in the world. Therefore, one of the key challenges is pushing new products through the necessary approval processes of the relevant authorities, such as the EMA, FDA, PMDA and SFDA.

In addition to medical and clinical aspects, consistency in the submitted documentation plays a key role: Consistency of content, formulations and terms in clinical studies, accompanying documents, R&D documents and similar documentation avoid time-consuming queries and costly correction loops, thereby considerably reducing the time to market.

Collaboration in harmony

  • Online teamwork for text production, text revision and validation
  • Immediate availability of modified and corrected documents for all authorized users
  • Detailed change tracking

» CLM WebEdit: Teamwork in real time

Make simple use of validated terminology

Managed terminology processes accompany terms from their creation in the source language to their approval for the translation process.

Validated company terminology – together with standardized terminology collections such as MedDRA – can be easily accessed by all parties: Online, via SharePoint search, directly in Microsoft Word and in the professional translation tool.

» TermStar: Create clarity

» WebTerm: Understand content worldwide

Change tracking in the approval process

An essential prerequisite for approval is for document revision history and the respective content to be fully traceable, in line with regulations.

STAR CPM maintains an overview of the respective feedback and revision statuses during the information exchange process: This means that you always know when something was changed, supplemented or corrected and by whom.

» STAR CPM: Accelerate processes while maintaining control