
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.
Fierce competition and a pressing need for revenue replacements, at a time when patent expiration hands business over to generics manufacturers, forces pharmaceutical companies to introduce new products on an international scale quicker and more effectively.
In these challenging times, it is critical for pharmaceutical companies to achieve excellence throughout the entire product cycle from discovery, preclinical, clinical, regulatory approval and commercialisation process, Any improvement in terms of time to market have enormous financial impact. 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 in lost revenue.
SDL has pioneered significant business process improvements applying Global Information Management best practices to clinical, regulatory (including PIM) and the commercialization processes.
There is a an untapped business opportunity for drug manufacturers to professionalize the mandatory local language delivery to patients, doctors, pharmacists, regulators, ethic committees, health care providers, and safety experts.
The accelerated aging of world population drives the need for cardiovascular and respiratory devices. 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 with trends such as wireless capabilities for hospitals and remote patient monitoring.
Despite ongoing growth, medical devices manufacturers are threatened by government efforts to reduce ever increasing healthcare costs pushing for higher competition in the market place. 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
Medical devices and equipment manufacturers therefore rely on SDL solutions to accelerate time-to-market for their products while preserving highest levels of quality to meet the conditions from regulators like the FDA and EMEA. Proven solutions from SDL 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.
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.
Clinical trials are the most time-consuming and labor-intensive part of the approval process for a new drug. Because of this they are often undertaken in multiple countries simultaneously. Clinical trials involve hundreds or thousands of discrete documents and modular data prior to completion for approval of a marketing authorization.