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Clinical Evidence in Digital Health: Considerations for Multi-Country Evidence Generation

The global adoption of digital health solutions has revolutionized healthcare delivery, offering unprecedented opportunities for innovation in patient care, diagnostics, and disease management. However, the generation of robust clinical evidence to support these technologies across diverse regulatory, cultural, and healthcare system contexts remains a significant challenge. In this webinar, Alexandra Crane, VP of COA, Digital Health, and Regulatory Solutions at TransPerfect...

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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 governance. What they have is Microsoft Word; it’s easy to use but limited to cut-n-paste content reuse. What they must deliver is multi-lingual content for a variety of uses–faster, more cost-effectively...

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Clinical Content Trends: 2023 Reflections and 2024 Projections

Over the past decade, the pharmaceutical industry has transformed significantly, giving way to breakthrough therapeutics and innovations for improved patient outcomes around the world. With these changes, there’s also been significant developments in the way organizations are approaching business, and with it, the processes that surround managing clinical content. In this webinar, our experts will reflect on some of the most significant insights that 2023 has regarding...

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Part 1: Clinical Trials and COVID-19: Situation now, its challenges, and the future

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 Life Sciences hosted Part 1 of the Clinical Trials and COVID-19 webinar series with industry experts to exchange ideas and provide insights into the impact of...

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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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COA White Paper | The Tale of Two Trials

In “The Tale of Two Trials,” Mark Wade takes an in-depth look at the benefits and drawbacks of the traditional, paper-based outcomes assessment method, as well as the advantages of the emerging electronic clinical outcomes assessment (eCOA) solutions. With each having the potential to affect data quality, timelines, and overall trial cost, the choice between them is a much discussed topic....

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Buyer’s Guide: PV Reporting AI and Automation

Considerations for selecting modern pharmacovigilance (PV) and safety solutions that improve adverse event detection, assessment, understanding and prevention. Download your copy to gain expert insights into developing and implementing a robust automation strategy for PV & Safety workflows. ...

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Could Data Standardizations be the Silver Bullet for Faster Electronic Clinical Outcome Assessment (eCOA) Deployment?

Choosing an electronic clinical outcome assessment (eCOA) provider is a complex process that involves a variety of different aspects including experience, scientific support and knowledge, integration capabilities, scalability, study-specific requirements, and so much more. With the surge of eCOA providers all deploying differing technology platforms with differing architecture and file exchange processes, the landscape is shifting and becoming opaque. Deploying an eCOA...

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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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Part 1: Clinical Trials and COVID-19: Situation Now, its Challenges, and the Future

Part 1: Clinical Trials and COVID-19: Situation Now, its challenges, and the Future 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 Life Sciences hosted Part 1 of the Clinical Trials and COVID-19 webinar...

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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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Digital Transformation Fireside Chat

In this fireside chat, Christine Buggle-Spearing and Dr. Gigi Shafai, Pharm.D., from TransPerfect Life Sciences, share practical strategies for modernizing medical affairs processes. The discussion covers how to design a digital-first strategy that creates value for both patients and organizations, use digital platforms to enhance collaboration with healthcare professionals and patients, and prepare teams for the evolving impact of AI on the medical affairs landscape....

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Digital Health Global Expansion Roadmap

For digital health companies—whether startups or tech giants—successfully launching new digital health apps starts with user adoption. To ensure long-term sustainability, these apps must attract, engage, and retain a diverse user base, which means they need to be culturally and linguistically accessible to a global audience. ...

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Data Standardization COA Whitepaper

With the surge of eCOA providers deploying differing technology platforms with differing architecture and file exchange processes, the landscape is shifting and becoming opaque. Deploying an eCOA solution faster and more costeffectively is a clearer focus for Sponsors now. Indeed, faster deployment is a key differentiator for this new breed of eCOA providers. So how will they achieve this light-speed deployment?...

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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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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 and operational execution of clinical trials in the European Union (EU) and European Economic Area (EEA) Member States. Discover the main features of the CTR, including the use of the "Regulation...

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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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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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Driving Commercial Success in Life Sciences with GenAI for Scalable Impact

Life sciences organizations are turning to AI/ML to enhance operational efficiency, with GenAI taking center stage as a game-changer for commercial teams. Beyond process optimization, AI is accelerating the adoption of omnichannel strategies by enabling and improving precise, personalized communication with patients and healthcare professionals. As AI-powered content generation continues to evolve, understanding the diverse applications and potential organization-wide impact...

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Engaging Patient Communities: A Pathway to Clinical Trial Success

In this webinar, expert speakers from MTS Sickle Cell Foundation, Inc, Rare Disease Diversity Coalition, Black Women’s Health Imperative, and Clinical Research Associates, Inc. will focus on the critical role of patient communities in advancing clinical trials. They will explore best practices for engaging with patient communities to enhance recruitment, retention and overall success of the trial. Based on case studies and interactive discussions, attendees will learn how...

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eCOA Vendor Localization Best Practices Checklist

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up. It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance, and configurability. The investment of both time and money, not to mention protecting and upholding the integrity of the data collected, is critical when seeking regulatory approval and confirming drug...