A significant amount of the valuable time under patent protection is consumed during clinical and regulatory approval stages.

It is surprising that while most of the business processes are constantly revised, the multilingual processes that are on the critical path and do bear the potential to deliver tremendous future business improvements are often neglected. This is why pharmaceutical market leaders have implemented SDL solutions—or are deploying SDL hosted solutions.

The discovery and preclinical stages are typically managed in an scientific English-only environment. As soon as product delivery enters the clinical stage an ever increasing number of information has to meet the legal requirements to inform an ever broader global audience.

Local language is mandatory for various types of activities and the underlying processes are dealing with geographically dispersed teams, very high quality requirements, painfully slow back-translation practice, highly redundant text types, tight deadlines and handling of thousands of documents in 50+ languages preparing for 140+ markets. Numerous updates and amendments are synchronized across languages, racing through complex review processes to meet deadlines. Some organizations monitor more than 18,000 different global deadlines per year, and again, one missed deadline introduces highly costly delays.

In Addition, the pharmaceutical industry is in the early stages of shifting from paper and Microsoft Word to structured electronic content with moving critical content types like internal core data sheets or, driven by regulatory requirement, the common technical document (eCDT) to electronic or XML. Especially the regulatory application process (labeling) is pushing product information to multilingual structured representations like SPL as required from the FDA or the current launch of PIM by the EMEA.

SDL opens world markets for pharmaceutical companies  

SDL’s global information management (GIM) solutions reuse content assets across documents, projects and across the product life cycle stages, saving weeks of authoring and translation work, thus accelerating research dissemination, regulatory compliance and product rollouts. SDL GIM solutions also optimize the accuracy and consistency of information provided to regulators, health care professionals and patients, so customer satisfaction is significantly increased.

SDL enables pharmaceutical companies to centrally administer the distributed processes required to deliver global information, so projects such as international clinical trials and adverse event reporting can be managed for quality and cost-effectiveness.

By enabling simultaneous worldwide product launches and marketing campaigns, and by automating best practices for global information management, companies that use SDL solutions are able to improve revenues and reduce the costs of compliance and to counteract global brand dilution.

Applying Global Information Management

SDL has gained specialist knowledge working tightly with pioneering pharmaceutical companies to redefine multilingual processes . Read more about the SDL solutions for: