In the highly-regulated life sciences industry, accuracy, quality and time-to-market are vital in the pursuit of global markets. SDL has expertise in the technology, services and processes required for this industry.
Life sciences companies face intense pressure to introduce products, ensure compliance, and accelerate revenue in every country in which they do business.
From clinical trials data and treatment protocols to SPL and PIM labels, every life sciences product requires a tremendous amount of information. For each individual country, it must all be localized to meet regional needs: legal requirements, local languages, cultural nuances, and more.
Thousands of regulatory documents in many languages are commonly being processed at any given time, with updates several times a year, racing through complex review processes to meet deadlines. Some organizations monitor more than 18,000 different deadlines in many countries every year, and one missed deadline can mean a six-month delay in an approval process. Even one day of delay is costly. Analyst firm Cutting Edge Information estimates that each additional day a drug spends in development can cost a company from $600,000 to $8 million per day in lost revenue.
Requirements for meeting eCTD standards and cross-media publishing requirements (print, web, XML, etc.) increase the complexity of these challenges.
The paradox is that as entering global markets quickly and profitably has become essential for life sciences companies, it has also become riskier and much more difficult.
That is, without SDL Global Information Management.
SDL’s global information management (GIM) solutions reuse content assets across documents and projects, 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 physicians and consumers, so customer satisfaction is increased.
SDL enables 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.
Join Astoria, SDL, and guest host Frank Gilbane, publisher of The Gilbane Report, for an online web seminar and learn how Siemens Medical went from strategy to solution implementation to publish its 2,200 product operation and maintenance documents in over 22 languages.
With increasing frequency, regulatory authorities are demanding information in their local languages. Industry leaders are challenged to meet the milestones in EMEA's Central Procedure (PIM). Yet the road to successful multilingual PIM submission is full of challenges.
"The really attractive aspect of SDL is the fact that it builds on human intelligence. Computers have excellent memories. By capturing past human translations in a computer- resident translation memory, we combine the best of both worlds."
Best Practices for Addressing Labeling Language Requirements
Expanding the world market for life sciences. More than 30 SDL customers in the life sciences field are successfully using SDL solutions to tap incremental revenue sources without additional R&D, support regulatory compliance and speak with one voice worldwide while improving service provider and patient interactions.