Last Updated: December 31, 2019 2:49AM
The healthcare industry is constantly evolving. 2019 was no exception. Life sciences companies—and their partners—must remain appraised of these new developments and stand at-the-ready to adapt and respond. This year, Lionbridge Life Science’s ever-vigilant experts reported on MDR and clinical trial regulations, the introduction of new digital tools, and the interplay of language and translation within these aspects of healthcare.
Here are our readers’ favorite life sciences blog posts of 2019:
A new EU Clinical Trial Regulation will impact the clinical trial process in myriad ways. In our new whitepaper, we dive deep into four ways the regulation will affect trial sponsors around the globe.
Plain language summaries are a patient and public-friendly summary of clinical trial results. A new clinical trial regulation in the EU mandates the provision of plain language summaries by all clinical trial sponsors executing clinical trials in the EU. The importance of maintaining accuracy in the authoring and translation of these summaries cannot be overstated. Read our article for a Lionbridge expert’s opinion on the impact of the new regulation.
Amongst all of the changes brought by new MDR and IVDR regulations, one element plays an increasingly important role in maintaining regulatory compliance and the safe use of medical technologies in all markets: language. Lionbridge has a strong track record in MedTech translation and linguistic support. Our life-sciences division can help achieve linguistic compliance and accurate content in all 24 official EU languages under the new MDR and IVDR, making sure that that you are prepared for any linguistic challenges brought by these new regulations.
China is an economic and industrial global force. It is no surprise that in the pharmaceutical field, the Chinese market has notable influence world-wide. In 2019, Lionbridge experts noted significant regulatory reforms in China that could facilitate more clinical research and drug launches in China. Read our article for insight on three key impacts.
Regulations for medical device technology are only getting more complicated. The ISO 13485:2016 certification focuses on risk management and risk-based decision-making for both device manufacturers and external support resources. Lionbridge Life Sciences has the full suite of medical, technological, and linguistic expertise you need to support these new regulations.
The digital health revolution is touching all aspects of the healthcare industry. Clinical trials stand at the forefront of these changes. This year, Lionbridge Life Sciences reports four digital tools with an enormous impact on clinical trials and great promise for global healthcare.
Clinical trials are as complex to plan as they are to execute. It is crucial that clinical trial sponsors and CROs implement a comprehensive approach to Clinical Outcome Assessments (COAs). At Lionbridge, we know this includes planning for translation at every step. Read our article and learn how to overcome translation challenges and optimize your COA process.
The Summary of Safety and Clinical Performance (SSCP) is a new requirement for high risk medical devices under the MDR which is intended both for healthcare professionals and patients. Language and readability are emphasized in the regulations as key vehicles for bringing results to patients in non-technical, plain and local language. Ensuring that this material is translated accurately and effectively is of the utmost importance. Lionbridge expert, Pia Windelov outlines the new SSCP requirements and its linguistic implications in our top performing article.
The current clinical research landscape is incredibly vast, and the number of trials occurring worldwide grows higher every year. How can healthcare businesses maintain compliance in the face of continuously evolving regulations? Read our three tips companies can employ to reduce complexity in the clinical labeling process.
The ever-changing healthcare industry demands constant vigilance. With 2020 fast approaching, pharma and Medtech sectors must stay attuned to inevitable regulatory and technological advancements. Lionbridge Life Sciences has experts on-hand, with the medical, technological, and linguistic background to respond and adapt to any new translation needs.
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