Thought Leadership
Medical Device Regulation: Less Time Than You Think?
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...
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...
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...
Digitizing Multilingual COAs: A Practical Guide
Download our guide to ensuring seamless digitization of your multilingual COAs. ...
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...
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...
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)...
Top 10 Prompts to Ask ChatGPT for Optimizing Clinical Trial Recruitment Strategies
Patient recruitment and engagement are critical to the success of clinical trials. Yet despite the tremendous progress made in drug development, recruitment and retention remain major challenges. Over the last 25 years, the industry has attempted to crack the code; however, 86%...
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...