Thought Leadership
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...
Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology
Digital technologies are reshaping rare disease studies, placing the question of data integrity firmly in the spotlight. In this recap from our C3 Summit Session titled Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology, we examine the impact of...
LifeSci Talks COA Series | Data Science: The New Frontier
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences sits down with Dr. Elizabeth Bacci, Senior Research Scientist at Evidera, to discuss critical aspects of developing meaningful and relevant Digital Health instruments. The...
Sponsor Strategy for Controlling Content and Language Complexity
Modern clinical trials span multiple sites and locations, requiring intense communication, documentation, and data management. As a result, many trial sites operate under a vast constellation of vendors to address patient, process, and regulatory needs, yet the external support...
The Ultimate Clinical Trial Translations Checklist
Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and communication work streams. These work streams can represent a significant source of cost, risk, and time. When a...
Anticipate Your Language Needs: The Ultimate Clinical Trial Translations Checklist
Explore the world of clinical product development and discover the pivotal role of accurate translations in global clinical trials. Empower your study teams to navigate language challenges, ensuring patient safety, regulatory compliance, and successful outcomes. Achieve these...
CCMS: A Good Fit for Pharmaceutical and Clinical Research Organizations?
Kaarin Gordon discusses the choices and challenges for efficient content reuse facing Pharmaceutical and Clinical Research Organizations. What they want is a set of tools and platforms for easy content reuse, automatic propagation of changes from a single source, and content...
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...
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...
Walking the Tightrope: Navigating Patient Centricity and Burden in Modern Clinical Trials
Explore the evolution of clinical trials and the challenge of patient burden. Learn how to strike the right balance between patient-centricity and research data extraction....
Digitizing Multilingual COAs: A Practical Guide
Download our guide to ensuring seamless digitization of your multilingual COAs. ...
Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content
Discover how Health Canada's transition to XML-based templates is reshaping Canadian healthcare content management. Learn about the benefits of XML formats, phases of implementation, and the transformative potential for pharmaceutical companies. TransPerfect Life Sciences...
Leveraging Technology and Bridging Gaps for Enhanced Clinical Data Management
Discover how technology-driven solutions are bridging gaps in clinical data management. Learn about challenges, trends, and strategies to enhance efficiency and streamline workflows for successful clinical research....
Transitioning Clinical Trials Under the EU CTR
The transition from Clinical Trial Directive to Clinical Trial Regulation in Europe adds new requirements and complexities to the clinical development landscape. The required transition of all trials concluding January 1st, 2025 brings about several considerations to ensure...
Driving Success in Omnichannel Content Strategies for Global and Local Markets
During our session at NEXT Pharma Summit in Dubrovnik, we explored the crucial role of an effective omnichannel approach in life sciences marketing. Seamlessly integrating multiple channels while considering the needs of global and local affiliates can unlock opportunities to...
Navigating the Regulatory Landscape for Expanded Access Programs
Preview: Discover the world of expanded access programs (EAPs) and the dynamic regulatory environment they operate in. In this blog, we delve into the significance of EAPs, the evolving global regulations governing them, and the vital role they play in providing timely treatment...
Beyond Borders: Navigating the Complexities of Omnichannel Content Strategy for Global and Local Markets
Hosted by Christine Buggle, Senior Director at TransPerfect Life Sciences, in discussion with Ewelina Knigawka, Executive Director of Content and Partnership Excellence at Novartis, and Scott Dille, Digital Content Lead at Novo Nordisk, this session outlined key considerations...
The Role of Qualitative Interviews in Ensuring a Patient-Centered Approach to Clinical Trials
Discover how qualitative interviews (CE, CD, PE, EI) enhance clinical trials. Learn best practices for conducting patient-centered interviews and ensuring accurate, meaningful data. Trust TransPerfect Life Sciences for expert interviewers and top-quality translation and...
EU CTR: An Introduction to European Clinical Trial Transparency
Are you looking to stay ahead of the curve in the ever-evolving landscape of European clinical trials? We are thrilled to announce the availability of our newest on-demand webinar, in which we dive deep into the recent changes to the European Clinical Trial Regulation (EU CTR)...
EU CTR White Paper - Operational Considerations & Challenges
The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness...
Intelligent Automation for MDR & IVDR Content: Summary of Safety & Clinical Performance (SSCP), Summary of Performance (SSP), and Selected Labeling
Content requirements under the EU’s MDR and IVDR, including the translation of labeling, marketing, SSCPs, SSPs, and clinical communications, are set to dramatically increase. Currently, most device manufacturers use manual processes and document-based applications like Microsoft...
LifeSci Talks COA Series | Harnessing Implementation Science to Improve Health Outcomes: Methods and Approaches for the Future
Implementation science emerged as a response to the recognition that many effective health interventions and innovations were not being widely adopted or sustained in practice, even when evidence of their efficacy was strong. Join Meredith Smith, Senior Director of Implementation...