Life Sciences

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.

Issues and Challenges

Fierce competition and a pressing need for revenue replacements, at a time when patent expiration hands business over to generics manufacturers
A requirement to achieve excellence throughout the entire product cycle from discovery, preclinical, clinical, regulatory approval and commercialization process
Minimally invasive surgery and the emerging neurostimulation segment, as well as other high-growth areas including therapeutic devices, endoscopy, infusion systems, diagnostic and monitoring equipment, audiology, and instrumentation devices are experiencing high product innovation and technological advancement cycles
Today, on every medical devices executive's agenda you will find:
- Increasing R&D costs - Shorter product lifecycles
- Driving cost down whilst maintaining Compliance
- Increased regulatory requirements
- Lengthy documentation procedures and increase time to market
You need proven solutions to allow for simultaneous global shipment for increasingly complex products and product-related content, as well as cost efficient procedures for local language delivery, integrating outsourcing partners, dealers, distributors and clients worldwide.

Reduce time-to-market and improve business processes
SDL applies Global Information Management best practices to clinical, regulatory (including PIM) and the commercialization processes. Share content, reuse it and make it relevant to the different knowledge and expertise of the different users of that information. Use automation to ensure you get information out to different markets quickly to beat your competitors.

Control your content and provide audit trails of processes
Whether the content is website content or technical information or whether it is the translation process you need to audit, SDL’s systems trace back the different steps in the workflows, providing audit trails on all your web and technical information, no matter which language.

Ensure high-quality multilingual content to meet the conditions from regulators like the FDA and EMEA
SDL has both the technology and translation services to improve processes and quality and follow Good Clinical Practice. The right people, with the correct medical experience will also translate your content to ensure it is clinically correct. Use technology and expertise to ensure consistency of the terms used and provide information to people where they need it through hand-held interactive devices.

Solutions

Write your content in a way that it is structured and can be reused, managed and audited
Personalize the content to the user of the device or drug, while reducing the cost of managing supporting content
Use a solution for your website that can cover audit trails for any claims that are made
Control what is written about you and look back to an audit trail of changes. Publish to multiple local sites, while staying in control of the content
Localization services to help you translate your content
Provides the translation services to ensure people with the expertise in medical translations ensure your content is correct and meets regulatory requirements
Technology to automate the localization process and hook into your existing systems
A series of technology helps ensure the consistency of terms you use, while providing an audit trail of the localization process