Thought Leadership

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...

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...

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...

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...

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...

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...

Digitizing Multilingual COAs: A Practical Guide

Download our guide to ensuring seamless digitization of your multilingual COAs. ...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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...