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Meeting the MDR & IVDR Content Challenge: New AI and Automation Solutions for New Requirements

The European Union's introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) marks a significant shift towards enhanced transparency in the medical device sector. While these regulations are designed to strengthen patient safety following several high-profile device failures, they have also created complex labeling updates and post market reporting requirements. Medical device companies must now navigate these complexities...

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LifeSci Talks COA Series | The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe

Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site-centricity, HTML5-based app wrappers, regulatory advancements during the pandemic, and the importance of flexibility in clinical trial technology adoption....

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LMS: A Must For Study Compliance And Efficiency

Life Sciences organizations function in a heavily regulated global environment, as such, have strict training requirements when it comes to investigative site staff and vendors with involvement in a study protocol. This training is necessary not only to minimize the risk of findings during regulatory inspections, but also to improve quality and performance of trial conduct. A comprehensive learning management system (LMS) that efficiently delivers, managers and tracks...

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LifeSci Talks COA Series | The Age of Bring Your Own Device: Considerations for Accessibility in Trial Design

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Dr. Florence Mowlem, VP of Science at ObvioHealth, to discuss maximizing patient accessibility in trial design. This includes implementing accommodations for patients with physical and cognitive limitations, and ensuring thoughtful applications of electronic modalities....

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MDR and IVDR Timeline Overview

In order to take advantage of the MDD extension, device manufacturers must comply with several near-term deadlines and plan for long regulatory turnarounds – the extension provides less time than you might think! Learn how TransPerfect can help you meet the impending MDR and IVDR deadlines with intelligent automation solutions for labeling, SSCPs, SSPs, marketing and other regulated content by downloading our MDR/IVDR deadlines cheat sheet!...

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Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities

As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU Clinical Trial Regulation became compulsory for all new interventional clinical trials of investigational medicinal products. All ongoing trials approved under the previous regulatory framework (EU...

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Optimizing Technology and Automation for Digital Health Products

Accurate and culturally appropriate translation of clinical outcome assessments (COAs), including patient-reported outcome measures, is essential to ensuring reliable data in multinational trials. Foundations of Clinical Outcome Assessment Localization will provide a practical overview of why linguistic validation goes beyond standard translation and how it safeguards both data integrity and patient understanding. The session will cover current regulatory guidance, the steps...

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Optimizing COA/eCOA Workflows with Technology for Better Quality & Timelines

Efficient workflows are critical to keeping global COA/eCOA studies on schedule while ensuring the quality of localized content. This live webinar will explore how technology stacks and automation can streamline clinical localization from start to finish, through integrating translation management systems with EDC platforms, eCOA platforms, and eCOA libraries, as well as how to leverage automation for KPI tracking and workflow efficiency. The webinar will also clarify when to...

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Multilingual Labeling: Considerations for Efficient, Cost Effective and Compliance Labeling

Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from $100,000 to $700,000 in hard expenses. In worst-case scenarios, incorrect labeling might necessitate a complete product reproduction. Learn more about the strategies and solutions leading sponsors are...

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Omnichannel Marketing for the Pharmaceutical Industry

With rapid globalization and expanded marketing efforts, pharmaceutical organizations are discovering that pivoting from multichannel marketing to omnichannel marketing is key to revolutionizing patient engagement. Through tailored experiences across relevant channels, your teams can seamlessly connect with patients, physicians, and healthcare professionals by harnessing advanced analytics and technology to support global marketing initiatives. In this white paper, we...

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Patient Recruitment Strategies: Empowering Patients Through Accessible Information

From pre-screen to post-trial, patients require clear, personalized and supportive communication to navigate the clinical trial journey. Despite the industry’s recognition of patient centricity and the abundance of digital health solutions, many trial participants still struggle to understand treatment information and access resources tailored to their needs. These gaps can lead to confusion, frustration and distrust throughout the care journey. For digital advancements to...

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Part 4: Clinical Trials and COVID-19: Remote Investigator Meetings

The novel COVID-19 virus has forced a lot of rapid changes in a very short period. Personally and professionally, we are all learning how to adapt. While restrictions on our day-to-day lives impact where, why, and how we interact, we still can come together as a community to learn, grow, and overcome. TransPerfect's Trial Interactive presents Part 4 of the Clinical Trials and COVID-19 webinar series with industry-expert Penelope K. Manansco to discuss the best...

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Personalized Pathways: Building an Omnichannel Ecosystem for Life Sciences

In an increasingly globalized digital landscape, the demand for personalized content has never been greater. Listen as Joy Wendelken from Johnson & Johnson alongside Sara Green of WebMD Ignite in conversation with Dana Weber from TransPerfect Digital discuss how omnichannel marketing is helping pharma companies better engage and more effectively reach patients and HCPs. You’ll hear about: • The importance (and challenges) of tailoring content in an era of information...

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Part 2: Clinical Trials and COVID-19 Converting to Remote Trial Management – How to Get Started

The novel COVID-19 virus has forced a lot of rapid changes in a very short period. Personally and professionally, we are all learning how to adapt. While restrictions on our day-to-day lives impact where, why, and how we interact, we still can come together as a community to learn, grow, and overcome. TransPerfect's Trial Interactive hosted Part 2 of the Clinical Trials and COVID-19 webinar series with industry experts to discuss the best strategy to make the...

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Part 3: Clinical Trials and COVID-19 Adapting to Rapid Change

The novel COVID-19 virus has forced a lot of rapid change in a very short period of time. Personally and professionally, we are all learning how to adapt. While restrictions on our day-today lives impact where, why, and how we interact, we still can come together as a community to learn, grown, and overcome. TransPerfect's Trial Interactive hosted Part 3 of the Clinical Trials and COVID-19 webinar series with representatives from a Sponsor and Site to discuss how they...

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Sanofi’s Journey of Digital Transformation through AI-Powered Translations

The global clinical landscape is becoming more complex every day, with evolving regulations and increased pressure on life sciences organizations to reduce costs and timelines. Join us for an in-depth discussion on how one of the world’s leading pharma companies is leveraging AI to enhance their translation processes, quality, and globalization strategy across internal departments. From integrations between cloud-based translation systems and regulatory platforms to...