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Content Solutions for MDR & IVDR Readiness

The implementation dates for MDR (May, 2021) and IVDR (May, 2022) are fast approaching and non-compliant manufacturers are putting their EU market access at risk. These new regulatory requirements have created a “tsunami” of increased content requirements—especially in critical areas such as labeling, post-market surveillance and vigilance, software UI, marketing, and training. Manual processes and document-based systems (like Word, InDesign, and FrameMaker) simply cannot...

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Enabling Diversity & Inclusion in Clinical Trials: A CRO & IRB Perspective

Diversity in clinical research is imperative to ensure the safety and effectiveness of drugs and medical devices for all people—and everyone in the industry is a key stakeholder. Clinical trials today still lack ethnic diversity, and to make trials more inclusive and improve equity in research, we ALL have a part to play. TransPerfect Life Sciences’ webinar series will take a closer look into each stakeholder’s role, current challenges, misconceptions, and activities for...

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Be Where Your Patients Are: Effective Digital Strategies For Patient Recruitment

Did you know that 15–20% of studies do not launch due to unsuccessful patient enrollment? In the past, recruiting the RIGHT patient population has been complex, expensive, and challenging, especially when it comes to rare diseases or niche requirements. Join TPT Digital’s Director Brian Hansen to discuss how: - Digital marketing is an easy, inexpensive, and effective tool for patient recruitment - TPT Digital helped Amarex, a global CRO, recruit LGBTQ, HIV positive...

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Shaping The Future of eCOA/ePRO

We have witnessed a rapid and dramatic migration from paper to electronic COA/PRO in the past few years. TransPerfect Life Sciences' C3 Summit brings to you virtual sessions on how the paper to digital migration is evolving, the use and application of eCOA migration technology, and setting up successful eCOA solutions....

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Content Automation to Meet MDR & IVDR Requirements

Marc Miller, President of TransPerfect's Medical Device Solutions chatted with experts from Takeda Pharmaceuticals & QServe to learn about MDR & IVDR labeling compliance while cutting risk, cost, & turnaround by using structured content, process automation, & advanced AI technology....

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Driving Digital Excellence: Delivering Seamless and Personalized Customer-Centric Experiences

The digital evolution in reaching and engaging with global communities, including sponsors, CROs, patients, and HCPs, has drastically shifted the way medical affairs teams connect with key stakeholders. As the industry pursues ways to improve a consumer and patient-centric approach, an omnichannel medical strategy is critical for continuing to drive collaboration, improve customer relations and patient trust, and disseminate and distribute medical information to global...

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Considerations and Opportunities in Capturing Oncology Patients’ PRO Data

There has been a historic lack of guidance in capturing patient data for oncology patients. Join Bill Byrom, VP and eCOA Scientist at Signant Health in conversation with Mark Wade, Global Practice Leader at TransPerfect, as they discuss: - The need for specificity of instruments to lead to greater use of PRO data in labeling claims - The impact of the draft FDA guidance to instrument selection and COA measurement strategy - The potential of item banks and augmentation of...

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Building a Successful Partnership: Meeting Sponsor Expectations

To improve clinical trial electronic system development, strong partnerships must be built and maintained between key stakeholders to establish centralized consensus and alignment for high-quality electronic data capture. Join Aaron McCormick, Associate Director, eCOA Implementation at Moderna in conversation with Mark Wade, Global Practice Leader at TransPerfect, as they dive into: - Building and maintaining Sponsor eCOA standards. - Establishing a strong working...

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Considerations for Improving the Pediatric Experience

The rare disease space presents numerous challenges for clinical research and patient data capture. These challenges are only heightened for younger patient populations, where outcome measures and dosages need to be considered appropriately. Join Dr. Elin Haf Davies, Founder & CEO of Aparito, in conversation with Mark Wade, Global Practice Leader at TransPerfect Life Sciences, as they discuss: The disparity in data capture for pediatric populations. Considerations for...

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Fortune 500 Pharma Company Meets Critical Deadlines with TransPerfect Life Sciences’ COA Solutions

This spotlight reviews the challenges faced by a Fortune 500 pharmaceutical company in implementing Clinical Outcome Assessments (COAs) to measure the impact of their products on patients. It discusses the need for accurate and culturally appropriate translations of COAs for global trials. The document highlights how professional language services, such as those provided by TransPerfect Life Sciences, can offer solutions to ensure accurate and effective implementation of COAs...

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Swimming in a Data Lake of eCOA Wearables

We all know there is a significant increase in data collected from wearable sensors, but what does that mean for eCOA? In our latest whitepaper , Mark Wade, Global Practice Leader for TransPerfect Life Sciences examines the considerations of adopting these sensors as an addition to the typical Clinical Outcome Assessment (COA) tools used routinely today. What are the impacts on a study team? What are the considerations in selecting these modalities? Consumer grade vs....

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The Paper Chase - Clinical Outcome Assessments in the Digital Age

Patients are, at last, gaining a voice in healthcare. Stakeholders have come to recognize that patients have valuable information to share about their experiences with diseases and medications that should influence policy and treatment decisions. The U.S. Food & Drug Administration (FDA), for example, has launched an initiative, “The Voice of the Patient,” to gather patient perspectives across specific disease areas. Information reported by clinical trial participants...

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Lessons Learned in the Rush for a Vaccine and the Effects on Language Translation: Creating and Adapting Technologies

The rush to a vaccine has accelerated an already dynamic research process. This has led to many innovations and an evolution of procedures. The language translation industry has seen enormous stressors and has had to create and modify processes and technologies similarly. The pandemic has changed society profoundly. The disruption in human and business interactions have not only affected the travel, conference, and hospitality industries but has also changed the clinical...