ARE TRANSLATIONS CAUSING DELAYS IN GETTING YOUR PRODUCTS APPROVED AND TO MARKET?
Client : The Michael J. Fox Foundation
Services : Translation
The Michael J. Fox Foundation is committed to curing Parkinson’s disease, and therefore works with leading specialists and researchers around the world. This mandate manifests itself in the global pool of talent utilized to perform the research. Due to the international nature of the foundation’s work, all components of the research and clinical trial procedures must be translated into a variety of languages with precision and accuracy to optimize results in the battle against Parkinson’s. Clinical trial documents, such as patient consent forms, full procedures, patient diaries, and patient reported outcomes must be translated properly to facilitate the development of new treatments and help forward progress towards a cure. In addition, marketing brochures and promotional materials pertaining to the foundation must be translated to increase international awareness of Parkinson’s disease and the foundation’s role in the ultimate goal of finding a cure for Parkinson’s disease.
The Michael J. Fox Foundation chose a long–term relationship with Park Life Sciences because they are confident that Park is best positioned to satisfy their translation needs in a timely, precise and cost effective manner.
Client : Electrostim Medical Services
Services : Translation for FDA Approval of Foreign Production Site
Electrostim Medical Services, a producer of specialized therapeutic and rehabilitation devices, was seeking FDA approval for a foreign production site. The company approached Park Life Sciences to provide language solutions for the entire FDA review process. Due to the complex nature of the device, the translations required a highly skilled linguistic team to translate hundreds of pages from Chinese into English.
Park’s strategic implementation managers devised a custom process to handle the seamless translation of technical schematics, design charts, detailed product manuals and operating and safety procedures. Additionally, as per FDA requirements, Park handled the subsequent translation of product performance tests, product inspection sheets, feedback reports, and regulatory compliance reports. Working under tight FDA imposed timelines; Park completed the project far in advance of the FDA deadline, and in a cost effective manner.
Our experience with leading biotechnology and pharmaceutical firms has given Park a prominent place in the life sciences translation industry. Electrostim Medical Services was able to rely on Park’s experience and knowledge to assure that the challenge of having foreign productions sites went smoother than anticipated and allowed the Electrostim team to focus on what they care about most, improving patients lives around the world.
As companies in the life sciences industry expand internatonally, they face growing regulatory translation challenges. Life science translations differ from those of any other industry. The technical subject matter is difficult to consistently translate correctly. Inaccurate translations often lead to long delays in product or drug development and regulatory compliance, as well as unsafe operating procedures, misinformed consumers, or even injured patients.
Park Life Sciences translates the most complex documents with a specific focus in life sciences. Park Life Sciences is a solutions-driven language service provider positioned to enable companies within this industry to overcome language and in turn regulatory barriers.
Our language professionals cater to elite, Fortune-ranked companies in the medical equipment, pharmaceutical, and healthcare industries.
We specialize in translating documents including study report forms, clinical study protocols, Intellectual Property and regulatory documentation.
Our industry-specific translators and project managers work closely with the clients to perform accurate translations specifically tailored to meet thier needs.
