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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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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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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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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 study operates across cultures, countries, and continents, these pain points of cost, risk, and time are compounded by the addition of translation and localization requirements. Study teams who can...

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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 ecosystem often falls into a tangled web, inviting new complexities that manifest in communication, collaboration, financial, data, quality, and risk management challenges. This white paper...

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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 conversation emphasizes the importance of aligning digital health tools with individual patient needs, and prioritizing the patient's perspective when developing instruments that are fit for purpose in...

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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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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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C3 Summit 2023 - San Francisco

Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session...

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C3 Summit 2023 - Boston

Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session...

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C3 Summit 2023 - London

Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session...

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C3 Summit 2023 - Princeton

Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session...

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Translation and Cultural Adaptation of Clinical Outcome Assessments (COAs): Is Machine Translation a Viable Option?

As technology continues to advance and the need to expedite drug development increases, the applications of Machine Translation (MT) and Artificial Intelligence (AI) in the translation process should be further explored. The capabilities of iterative learning and feedback can serve as a tool for translation, but the limitations should be considered. This poster will compare human translation (HT) and machine translation (MT) in the back translation step for Clinical Outcome...

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The Imperative of Automation in Pharmacovigilance and Patient Safety

Uncover the transformative potential of tech-enabled pharmacovigilance (PV) processes to maximize patient safety and streamline reporting. This white paper outlines the practical application of Artificial Intelligence (AI), Translation Management Systems (TMS), and other innovative solutions that are revolutionizing critical work streams. Equip your organization with strategies that improve patient safety, reduce risk, maintain compliance, expedite processes, and reduce...

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Keeping Patients at the Heart of Clinical Trials

Clinical trial patient recruitment continues to be challenging. Even with shifts to decentralize clinical trials and the addition of new vendors and technology, recruitment still is the primary cause of delays or discontinuation. What could we be missing? In this webinar, we’ll discuss the current state of clinical trials, historical challenges of recruitment, and new thinking to integrate human touch and improve retention. We will share frameworks and methodologies you...

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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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LifeSci Talks COA Series | Decoding Decentralized Trials: Navigating Novel Decentralized Research Challenges and Complexity

DCTs have picked up significantly in previous years, catalyzed by the pandemic and a move to remote research. With this move comes a host of new challenges, including those surrounding technical interoperability, resistance to adopting new technologies, and the need for flexibility in technology uptake at research sites. With additional considerations to be made, such as ensuring regulatory compliance, and enforcing standardized metrics in assessing DCT performance, this...

Data Annotation for Life Sciences

At DataForce, we specialize in elevating real-world clinical data through precise and efficient annotation services. From real-time adverse event (AE) detection for pharmacovigilance to social listening for trend identification, our expertly annotated datasets empower AI models, fostering innovation and success in clinical research and development.....

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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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LifeSci Talks COA Series | Licensing Challenges vs. eCOA Vendor Capabilities

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Stacey Higgins, Associate Director, COA & Digital Implementation, to cover the intricacies of clinical trial licensing, contract variations among eCOA providers, the importance of sponsor involvement, and the challenges of validated translations. Explore the complexities that can arise in these critical aspects of clinical trials...