Multilingual Patient Communications: Parting Lessons of the Pandemic
As the World Health Organization joins the United States in calling an end to the pandemic, few want more than to move on from a time of unrelenting challenges, but that timing may not be so fortuitous when it comes to capturing its most important lessons for...
MedTech and Medical Device Localization: Leveraging ISO 13485 for Multilingual Quality Management
With so much of MedTech resembling a medical device, and with more medical devices incorporating software and other digital components, it is ever harder to define what is a MedTech and what is a medical device localization project. With the possibility some projects...
Linguistic Validation for eClinical Patient Questionnaires: Driving Patient Centricity Through eCOA Translations
When it comes to setting up a foundation for diverse, patient-centric clinical trials, linguistic validation is an essential localization practice that can help prepare patient questionnaires for participants in diverse global regions, an essential to succeeding in...
Reducing Clinical Trial Delays with IVD Translations
When conducting clinical trials in Europe and around the world, accurate and effective IVD translations help mitigate clinical trial delays that stand in the way of device approval. In vitro diagnostic medical devices (IVDs), also called in vitro diagnostic products,...
Can Clinical Trial Translations Improve Sponsor Diversity Index?
Following the premiere of Bioethics International’s new diversity index in 2023, how can clinical trial translations improve a company’s future rating? Diversity in clinical trials has been a hot topic in recent years, even prompting the U.S. Food and Drug...
Personalization and Patient-Centricity in Pharmaceutical Labeling Translations
Among the many steps it takes to bring a drug to market, pharmaceutical labeling translations may seem like one small hurdle to overcome on the way to approval. Medical translation of pharmaceutical labels, which can include labels on the carton or package and a host...
ChatGPT in Healthcare: A Tool to Improve Patient Communication and Medical Translations?
Since OpenAI publicly released ChatGPT, a generative artificial intelligence (AI) that uses a large language model to produce human-like text, the possibilities for ChatGPT have taken just about every communication and translation-heavy industry by storm. But in the...
ePRO Translations: Cultural Adaptation for the Decentralized Clinical Trial
Patient-reported outcome (PRO) translations have long required linguistic validation before use in clinical trials, so with the rise of digital instruments in decentralized clinical trials, what additional considerations are there for electronic PRO (ePRO)...
eLearning Translations: Improving Medical Device Use Around the Globe
How can medical device companies leverage eLearning translations to improve the use of medical devices around the world? While patients are the end user for many medical devices, healthcare professionals are responsible for guiding patients in correct use, as well as...
Clinical Trial Corner: Quantifying the Socioeconomic Value of Industry Clinical Trials for Participating Countries
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. In our previous CT Corner posts we assessed patient diversity on a global scale and flagged countries and regions that appear to be...
Patient Recruitment Translations: A Treatment for the Reputation Disparity in Clinical Trials?
How can patient-facing materials and patient recruitment translations facilitate recruitment of patients particularly to countries underrepresented in global drug development? As we discussed in our latest Clinical Trial Corner post, some countries and regions,...
Clinical Trial Corner: Assessment of Countries’ Reputation Among Sponsors of Industry Clinical Trials
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. In the previous two-part Clinical Trial Corner miniseries, we provided a global assessment of patient diversity in industry CTs (iCTs)...
Neurocrine Biosciences Presents Additional Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at HSG 2022
Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a leading neuroscience-focused biopharmaceutical company, reported additional results from the Phase 3 KINECT-HD study investigating valbenazine for the treatment of chorea associated with Huntington Disease (HD). In...
AbCellera’s First Program with Regeneron in Multi-Target Collaboration Advances in Preclinical Development
AbCellera (Nasdaq: ABCL) announced that Regeneron has elected to exercise its right to advance a therapeutic antibody candidate, discovered in partnership with AbCellera as part of a multi-target collaboration between the companies, into further preclinical...
Unity Bio Set to Launch Pivotal DME Study after Significant Data
Shares of Unity Biotechnology surged in early trading Tuesday following the company’s release of Phase II data showing a single injection of its experimental drug provided visual improvements in patients with diabetic macular edema. A single injection of UBX1325 led...
Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy
Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, announced that the U.S. Food and Drug Administration (FDA) has granted...
NeoGenomics Provides Update on MolDX Submission for CRC and RaDaR(TM) Commercial Launch
NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetics testing services and global oncology contract research services, is providing an update on its discussions with MolDX and on its commercial launch activities for RaDaRTM, its proprietary...
Aphaia Pharma Announces Enrollment of First Patient in Phase 2 Study of APH-012 for Chronic Weight Management in Individuals with Obesity
Aphaia Pharma, a clinical-stage biopharmaceutical company harnessing precision-targeted drug delivery technology for the treatment and prevention of metabolic diseases, announced that it has enrolled the first patient as part of a Phase 2 study evaluating the safety...
Anixa Biosciences Announces Commencement of Phase 1b Trial of its Breast Cancer Vaccine at Cleveland Clinic
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced the initiation of a Phase 1b trial for its preventative breast cancer vaccine. The study is being conducted at...
Pharmaceuticals Translations for Diverse and Emerging Market Clinical Trials
In our most recent Clinical Trials Corner post, we examined the lacking global representation of diverse patient populations in the development of new biopharmaceuticals when compared to consumption of developed drugs by country, highlighting the need to expand and...