Latin America holds great promise for clinical trials – and for attaining the diversity goals increasingly mandated by regulatory bodies. At the same time, the region’s sheer size and diversity, … Continue readingLife Sciences—In Focus: Navigating The Regulatory Landscape – Latin America Edition
Vistatec Life Sciences attended RAPS Convergence 2024, the largest annual, regulatory-focused event in the world, hosted by the Regulatory Affairs Professionals Society (RAPS). Held in Long Beach, CA, it brought … Continue readingVistatec Life Sciences’ Key Takeaways from RAPS Convergence 2024
Marketing Communications in Life Sciences:Best Practices for Global Success Within the life sciences industry, products and solutions often have a truly global reach, meaning the importance of comprehensive marketing communications … Continue readingMarketing Communications in Life Sciences: Best Practices for Global Success
Vistatec Life Sciences – In Focus Podcast Ep 09 – Reem Yunis Dr. Reem Yunis, an accomplished scientist and life sciences consultant, joins Life Sciences – In Focus Host Karen … Continue readingLife Sciences — In Focus Podcast Episode 9 — Reem Yunis
What the research community has known for a long time recently became front-page news: Biomedical research has a diversity problem. Historically, clinical trials have enrolled primarily younger, white male participants. … Continue readingLife Sciences — In Focus: FDA Diversity Action Plans: Deciphering the Guidance and its Consequences
In this episode of Vistatec Life Sciences – In Focus podcast, Host María Mateos talks with Bre Grignano, a leader who brings her experience from the life sciences, sports, and … Continue readingLife Sciences – In Focus – Ep 8 – Bre Grigano, Associate Director at HiRO – Harvest Integrated Research Organization
Achieve the Results You Want from Your Diversity Action Plans In June 2024, the US Food and Drug Administration (FDA) issued a long-anticipated draft guidance to address the recurring issue … Continue readingAchieve the Results You Want from Your Diversity Action Plans
In this Life Sciences – In Focus Podcast episode, we catch up with Toban Zolman, the CEO of Kivo, a unified document management system transforming the regulatory landscape in life sciences. With over 20 years of experience developing and validating computerized systems for clinical trials, Toban has an extensive background that bridges regulatory rigor with modern technological innovation. … Continue readingLife Sciences – In Focus Podcast: Ep 05 – Toban Zolman, CEO, Kivo
On this insightful episode of the Life Sciences – In Focus podcast, Host María Mateos is joined by Brandon VanArman, a seasoned Software Systems Engineer and contractor at Medtronic, who shares his extensive knowledge and experience in software development for the life sciences and language industry. … Continue readingSoftware Engineering in Life Sciences with Brandon VanArman, Medtronic: Life Sciences — In Focus Podcast Ep 4
Vistatec Life Sciences expert Jackie Janeri joins Host María Roa on this episode of VistaTalks. Jackie is a seasoned professional with an illustrious career in the localization industry, particularly within Life Sciences. Jackie’s expertise shines through her extensive experience in program management at Vistatec Life Sciences, where she leads successful initiatives in multilingual content management, translation best practices, and more. … Continue readingExploring Life Sciences Localization with Jackie Janeri – VistaTalks Episode 143
In this Life Sciences – In Focus podcast episode, host Karen Tkaczyk sat down with Michelle Lott, the founder and principal of Lean RAQA, to discuss the intricate world of regulatory affairs within the life sciences sector. This conversation not only shed light on Michelle’s unique journey into the field but also explored the challenges and nuances of navigating regulatory pathways in the United States and Europe. … Continue readingThe Intricate World of Regulatory Affairs with Michelle Lott, Lean RAQA – Life Sciences — In Focus Podcast Episode 3
Despite the hype and enthusiasm with which organizations are implementing AI, it is still in its infancy and, as such, requires supervision and training. Particularly in regulated industries, we must be cautious and thoughtful when implementing AI. Here are ten instances in which you should not currently depend on AI. … Continue reading10 Areas Where AI Presents Risks in Regulated Life Sciences
In life sciences and other highly regulated industries, we must balance the desire for innovation and efficiency with our industry mandate to do no harm. We must be particularly thoughtful in implementing and using AI because mistakes in our industry can cause life-altering consequences. We cannot currently depend solely on AI vendors to determine what guardrails are necessary and desirable for our industry, which often has a higher standard of care than the tool vendors. … Continue readingThe Ethics of AI in Regulated Life Sciences
We are pleased to present an extract from a new article authored by Karen Tkaczyk Ph.D., Director of Sales at Vistatec, for this month’s European Medical Writers Association. This article titled “Translating medical devices: A rule-driven game” is available in its entirety on the European Medical Writers Association website, free of charge. The below extract provides a glimpse into the valuable insights provided in the full article, which we believe will be of great interest to our esteemed medical professional audience. … Continue readingTranslating Medical Devices: A Rule-Driven Game
In this Vistatec Life Sciences – In Focus Podcast episode, we hosted Eliana R. Burke, the Global Head of Client Engagement and Marketing at GreenLight Clinical. Eliana brought her professional prowess into the limelight. She shared her deeply personal and inspirational journey as a cancer survivor, melding professional dedication and personal resilience into a narrative that’s both empowering and enlightening. … Continue readingInspiring Hope and the Impact of Diversity, Equity, and Innovation in Life Sciences: Eliana R. Burke, GreenLight Clinical – Life Sciences — In Focus Podcast Ep 2
Real-world evidence (RWE) has been a hot topic in recent years, not only in the research and life sciences industry but also in public health. Given the challenges surrounding its ethical use and regulation, the increasing importance of AI and the sheer volume of data available suggest that this is unlikely to change any time soon. Vistatec invited industry-leading experts to share their insights, thoughts, and predictions on the role of RWE going forward at our recent “Real-World Evidence: Global Regulatory Landscape and Innovation” event.
… Continue readingLife Sciences — In Focus: Real-World Evidence: Global Regulatory Landscape and Innovation
In this new episode of the Life Sciences — In Focus podcast, hosted by Karen Tkaczyk, we welcomed a genuinely remarkable guest, Aman Khera, Vice President of Regulatory Science, Strategy, and Innovation at Worldwide Clinical Trials. With a career spanning nearly three decades, Khera is a force of innovation and a staunch advocate for diversity and patient inclusion in clinical research. Her journey from a curious student in the UK to a leading executive in the clinical research organization (CRO) space is a testament to her passion, resilience, and dedication to making healthcare better for all. … Continue readingDriving Diversity and Change in the Life Sciences Industry with Aman Khera: Life Sciences — In Focus Podcast Episode 1
Lay summaries (LS) “translate” complex medical terminology and concepts into language patients and consumers can understand – a task that must done carefully to avoid losing meaning or accuracy. Making these available in multiple languages is a highly complex, intricate process that requires the expertise of an experienced life sciences localization team to ensure successful communication and cultural appropriateness. … Continue readingTransparency, Comprehension, and Compliance: Key Factors in Translating and Localizing Lay Summaries (LS)
Life Sciences expert Karen Tkaczyk joins VistaTalks host María Roa on this podcast episode. Karen is a distinguished figure in the translation and language services sector, particularly within the life sciences domain. Currently Director of Sales – Life Sciences at Vistatec, Karen possesses a rare blend of scientific expertise and linguistic prowess, making her contributions invaluable to companies aiming to globalize their operations. … Continue readingLife Sciences Localization Strategy and Insights – Karen Tkaczyk – VistaTalks – Ep 136
Welcome to the introductory episode of the Life Sciences — In-Focus podcast, brought to you by Vistatec. The podcast introduces a new avenue for exploring the dynamic and ever-evolving world of life sciences. Episode 0 expertly set the stage for what promises to be a series of insightful and engaging discussions. Read the recap here. … Continue readingIntroducing the Life Sciences — In Focus Podcast: Expert Insights in Life Sciences
With improved guidance and the maturation of digital health technologies (DHTs), decentralized clinical trials (DCTs) are here to stay. This is excellent news in many ways: DCTs provide a path to addressing tough, longstanding challenges in clinical trials. Properly planned and executed, DCTs allow for accelerated cohort recruitment and clinical development timelines. Additional benefits include enhanced retention, better participant adherence, greater diversity, and more representative patient access, leading to a more robust evidence base. … Continue readingLanguage, Translation and Localization: Key Factors in Decentralized Clinical Trials (DCTs)
In the first installment of Vistatec’s Life Sciences – In Focus series, Amanda Murphy, Senior Director of Data Intelligence and Solutions at GlobalData, presented the biopharmaceutical industry’s outlook for 2024. The event yielded valuable insights into the trends and themes predicted for the upcoming year, focusing on the clinical trials landscape, including decentralized clinical trials and diversity. Read the key learnings here. … Continue readingLife Sciences – In Focus: Leveraging Data and Trends for 2024 – Key Learnings
Participant diversity is critical to achieving equitable representation in the clinical trial landscape. Sponsors must proactively plan outreach, enrollment, and retention strategies for diverse communities.
Such strategies should incorporate professional translation, language access, and culturally sensitive localization. Discover the importance of diversity in clinical trials and how LSPs can help.
… Continue readingDiversity in Clinical Trials: The Role of Language Services
In the intricate world of life sciences, the importance of localization extends far beyond mere translation. It’s a critical component that ensures patient safety, regulatory compliance, and the successful global deployment of medical products and services. María Mateos, an expert in localization and life sciences, recently shed light on the nuances of this field and how companies like Vistatec are leading the charge in providing specialized services that meet the industry’s stringent demands.
… Continue readingDecoding the Intricacies of Life Sciences Localization – VistaTalks Ep 130
In this episode, Host Simon Hodgkins is joined by Emer Sherry, Senior Executive, Public Policy and Regulatory Affairs at Irish Medtech Association, Ibec. The Irish Medtech Association is the business association within Ibec representing the medical technology sector. The Irish Medtech Association has more than 250 members located throughout the island of Ireland. The group’s broad focus is to promote and support an environment that encourages the sustainable development and profitable growth of FDI multinational and SME member companies. … Continue readingMedtech Innovation and Global Success – Emer Sherry – VistaTalks Ep 128
In this episode, Host Simon Hodgkins is joined by Olga van Grol-Lawlor, Senior Global Regulatory Intelligence and Advocacy Manager at Boston Scientific. The medical device industry stands at the intersection of healthcare and technology, continuously pushing the boundaries of what’s possible. However, with innovation comes the need for regulation, a topic that often finds itself at the center of many industry discussions. … Continue readingNavigating Medical Device Regulation with Boston Scientific’s Olga van Grol-Lawlor – VistaTalks Ep 127
In vitro diagnoses span a wide range of equipment and tests ranging from simple self-tests to detect pregnancy to complex laboratory diagnostics such as polymerase chain reaction (PCR) testing to diagnose genetic disorders and cancer. Considering the growing importance of in vitro diagnoses, the in vitro diagnostic regulation, or IVDR, was introduced to ensure high quality, outstanding results, and impeccable safety for the sake of all patients and doctors. … Continue readingIn Vitro Diagnostic Regulation (IVDR)
In this article, we want to examine what SaMD is and explore some key differences between SaMD regulations in the EU and US. We’ll also investigate how using artificial intelligence, and machine learning is set to shape the SaMD industry and the critical role SaMD regulations play in establishing trust and reliability in such continuous learning models. … Continue readingSaMD Regulations and Global Healthcare Innovation
Machine translation is on the rise. As more companies adopt machine translation, there is growing evidence that translating first with a machine and adjusting with human revision is faster and more cost-effective than human-only translation in many domains while still capable of achieving human translation quality where this is the objective. … Continue readingIs Machine Translation Ready for Life Sciences?
Kara Bolt is a multilingual (German, Spanish, and English) expert in localization and translation at Vistatec. She currently lives in Colorado, United States, where she enjoys the view of surrounding mountains from her home and how dog-friendly the areas are in her neighbourhood. … Continue readingMeet our Director of Life Sciences: Kara Bolt
By Elizabeth Riley, Director of Solutions Architecture, Vistatec and Giulia Mattoni, MT Program Manager, Vistatec Quality Translations for International Growth The broad reach of modern technology has connected businesses well … Continue readingMachine Translation in Life Sciences Localization
Think Global Awards Application Deadline Extended MOUNTAIN VIEW, CALIF. December 19, 2018 For Immediate Release The Think Global Awards application deadline has been extended from December 20, 2018, to January … Continue readingThink Global Awards application deadline extended
Deadline Extended for the Think Global Awards MOUNTAIN VIEW, CALIF. | December 10, 2018 For Immediate Release The deadline for the Think Global Awards has been extended to Thursday, December 20, … Continue readingThink Global Awards Deadline is Extended
The Think Global Awards 2018 – Open for Entries Simon Hodgkins, founder of the Think Global Forum, shares the news of the launch of the Think Global Awards 2018 after … Continue readingThe Think Global Awards 2018 – Open for Entries
Life Sciences 2018 Think Global Forum Announces Latest Life Sciences Event September 07, 2018 | Mountain View, California For Immediate Release The Think Global Forum for Life Sciences is set … Continue readingLife Sciences Event
Life Sciences Forum Executives Announced February 08, 2017 New Life Sciences Forum announced by Vistatec and Think Global Forum. A host of life sciences forum executives are announced ahead of … Continue readingLife Sciences Forum Executives Announced
