Thought Leadership
Insight

Clinical Outcomes Assessments (COAs) in Clinical Trials: Copyright and Licensing

Author: Maria Arnott and Corinne Shoch, COA/eCOA Licensing Management Team In clinical trials, it is usually necessary for sponsors to obtain permission to use copyrighted materials, such as clinical outcome assessments (COAs). The process to obtain these permissions is called...
Insight

How to Approach the Protection of Personal Data and Commercially Confidential Information of EU Clinical Trial Applications: Practical Considerations

Authored by Pierre-Frédéric Omnes, Executive Director The publication of clinical data has been a focus of public policies and regulations in the European Union (EU) in recent years to avoid duplication of clinical trials, foster innovation, and encourage the development of new...
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Localizing Platforms for Digital Health: The Importance of Post-Localization Context Review

In a landscape defined by continuous technological advancement, many organizations in the life sciences industry strive to increase audience engagement through digital modalities, such as mobile and web applications or web portals. Building a robust technological infrastructure...
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Navigating the Bias Challenge: Medical Data for Ethical AI in Life Sciences

From drug discovery to personalized medicine, AI systems are broadly transforming how we approach health and disease. The clinical development life cycle generates enormous volumes of data, and its potential is fully realized through the strategic application of AI tools, such as...
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4 Immediate Applications for AI Translation in Pharma

Precision and speed are key facets of success in the dynamic world of pharmaceutical development. To achieve these goals, AI-powered capabilities, such as machine translation (MT), can have a considerable and transformative impact.  Automated translation workstreams enable...
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ICH E6(R3): Understanding the Updated Good Clinical Practice Guidelines (GCP) and Their Future Impact

The International Council for Harmonization (ICH) announced revisions to its Good Clinical Practice (GCP) guidelines, marking a significant move towards more closely aligning clinical practice with the rapidly evolving technological landscape.   The purpose of the ICH...
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The Role of Artificial Intelligence (AI) in Clinical Outcome Assessments (COAs)

Written by Mark Wade, Global Practice Leader, COA SME. Abstract  Artificial Intelligence (AI) is the new frontier for content creation, reuse of language assets; saving time and effort in the curation of documentation. The widely adopted generative AI tools, such as ChatGPT...
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Five Essential Roles Artificial Intelligence Plays in Medical Writing

In the biotech and pharmaceutical industries, the importance of effective communication cannot be overstated. With a responsibility to accurately convey critical scientific findings, regulatory updates, and patient information1, the pressure is on medical writing teams to develop...
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Maximizing Learning on a Budget: 3 Cost-Effective Strategies for Clinical Education and L&D in Medical Device Companies

Are you struggling to provide high-quality training to your clinical education and L&D teams while keeping costs low? As the medical device industry continues to evolve and grow, it’s more important than ever for medical device companies to invest in learning and development ...
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Patient Recruitment and Inclusivity - The Patient Perspective

In the third installment of our annual series of C3 Summits which took place in London on September 13, we invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens...
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Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology

Introduction The question of leveraging digital technologies in rare disease studies with smaller patient cohorts is not one of ROI, but rather data integrity. When compared with traditional paper-based patient reported outcomes (PROs), data integrity is much more easily...
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Anticipate Your Language Needs: The Ultimate Clinical Trial Translations Checklist

“Content is king” is cliché marketing jargon, but in clinical product development, the cliché holds true. Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and...
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Walking the Tightrope: Navigating Patient Centricity and Burden in Modern Clinical Trials

Over the past few decades, clinical trials have witnessed remarkable developments - but they are not without challenges. Dropout rates of up to 20% indicate that patient burden and engagement remain key areas of concern. In response to this, sponsors, healthcare providers, and...
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Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content

In 2019, Health Canada initiated a significant process to transition all product monograph templates into a more advanced and structured XML format. This move by the regulatory authority has raised several questions for Canadian pharmaceutical organizations' regulatory and...
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Leveraging Technology and Bridging Gaps for Enhanced Clinical Data Management

Introduction: In the field of clinical research, a robust data management process is essential for driving success. Efficiently handling vast amounts of data, ensuring accuracy and consistency, and extracting meaningful insights are vital, particularly in the case of global...
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Driving Success in Omnichannel Content Strategies for Global and Local Markets

Introduction:   In the rapidly evolving landscape of life sciences marketing, implementing an effective omnichannel strategy is crucial to driving positive customer experiences and increasing engagement. By seamlessly integrating multiple channels and considering the...
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Navigating the Regulatory Landscape for Expanded Access Programs

Introduction: Expanded access programs (EAPs) provide pathways to treatment options prior to local marketing authorization in cases where traditional clinical trial participation is not feasible. Usually, these treatments involve investigational therapies (i.e., drugs, biologics,...
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The Role of Qualitative Interviews in Ensuring a Patient-Centered Approach to Clinical Trials

Author: Morgan Vlad-McCabe Clinical trials play a crucial role in advancing medical research and improving healthcare outcomes. Traditionally, they have primarily focused on objective measures and quantitative data to evaluate the safety and efficacy of treatments. In recent...
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The Future of eCOA and Wearable Devices

Electronic Clinical Outcome Assessment (eCOA) wearables have been a major player in the collection of large volumes of patient-reported data. With clinical research generating large and complex datasets at a rapid rate, the value of eCOAs is increasingly apparent, offering new...
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The C3 Summit: Boston Recap

The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world...
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How Medical Writing Can Drive Patient Engagement

Medical writing is a critical component of the broader patient engagement landscape, establishing the foundations of communication between pharmaceutical companies and patients. The quality of medical communication can be transformational in how a patient engages with and...
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Centralizing Global Content Solutions for Medical Affairs

With a rapidly evolving landscape and the introduction of new technologies and emerging therapeutics, medical affairs professionals are tasked with remaining in lockstep with the latest industry developments. From a content perspective, this means not only maintaining clear lines...
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The C3 Summit: San Francisco Recap

April 20 marked the first in our series of C3 Summits, which kicked off in San Francisco. Throughout the event, we invited industry experts to panel discussions to explore patient diversity, centricity, clinical technologies, and innovations. In this recap, we will...
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Overcoming 5 Challenges of Implementing eClinical Technologies

eClinical technology has transformed the clinical trial landscape, maximized data collection efficiency, and streamlined trial operations. Innovations in this space, such as electronic trial master files (eTMF), clinical trial management systems (CTMS), and electronic...