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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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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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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...
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Centralizing Global Content Solutions for Patient Engagement Teams

Patient welfare and engagement are central to an effective healthcare system, and engagement teams play a vital role in ensuring that patients receive the best care possible. In fact, a study conducted by the American Journal of Managed Care found that patients who are directly...
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The Quality Review of Documents (QRD) v9.0 for Veterinarians: A Step Toward Better Care

The Quality Review of Documents (QRD V9) update came into effect on January 28, 2022. The new version consists of a set of guidelines established by the European Medicines Agency (EMA) outlining the responsibilities and duties of those who ensure the quality of veterinary...
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Leveraging Social Media for Patient Recruitment in Clinical Trials

Identifying and connecting with prospective patients for clinical trials via social media and digital channels presents several challenges due to regulations that restrict patient communications. For example, the FDA has issued guidelines on the use of social media in patient...
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Hearing the Patient Voice Through Technology and eCOA

The intrinsic value of the patient’s voice has been heard. Over the past few years, Notifying Bodies have been ‘vocal’ on their desire for Studies to be more patient centric and diverse. Clinical Outcomes Assessments (COAs), a scientific instrument/measure whose primary function...
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3 Benefits of Centralizing Global Content Solutions for Regulatory Teams

The regulatory landscape is continually evolving, prompting pharmaceutical companies to adjust their strategies to remain in compliance with existing requirements. Since the remote shift throughout the COVID-19 pandemic, regulatory teams have been gradually embracing digitization...
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Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider

The EU Clinical Trials Regulation (EU CTR) became live on January 31, 2022. The first-year transition period ends on January 30, 2023, so from January 31, 2023, onward, EU CTR is mandatory for any initial submission of interventional clinical trials with investigational medicinal...
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Investigational Medicinal Products: Labeling Changes and Their Implications

This information has been updated based on a previous blog we published in 2021.   In May 2014, European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed, replacing EU Directive No. 2001/20/EC to enhance clinical trial safety, efficiency,...
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Benefits of Electronic Labels: Investigational Medicinal Products

When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, a label must be on its packaging that provides relevant and important information, regardless of the country in which it is developed. Types of information include...
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Decentralized Clinical Trials | TransPerfect Life Sciences

This is the second of a two-part series on our recent C3 Summits TransPerfect Life Sciences held C3 Summits in Princeton, NJ; Raleigh, NC; and London, England, where multiple subject matter experts came together to discuss clinical content. Throughout these events, we focused on...
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Lack of Diversity in Clinical Trials: A Conversation

Conversations on Clinical Content (C3) Summit Debrief: Diversity in Clinical Trials This is the first of a two-part series on our recent C3 Summits During the 2022 C3 Summits held in Princeton, NJ; Raleigh, NC; and London, England; TransPerfect Life Sciences was delighted to...
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Plain Language Summary Requirements for Clinical Trials

Plain language summaries (PLS) of Clinical Trial Results are a critical tool in medical communication to help disseminate summarized, easy-to-digest research information to general audiences. Typically, these are used to share details of clinical study protocols, publications, or...
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Reaching Diverse Patient Populations to Drive Inclusivity in Trials

The COVID-19 pandemic was catalytic in highlighting gaps in health outcomes across the globe, with global health inequity disproportionately impacting minorities and communities of color.With a litany of factors influencing individual patient outcomes and access to healthcare,...
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Connecting with Diverse Patients: How Call Centers Can Improve Patient Recruitment and Retention

Do you recruit patients for clinical trials? If the answer is yes, then how do you reach potential participants? Through emails? Ads on the radio? Do you call someone and see if they are interested? There are many different ways patients are recruited for clinical trials: in...
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Driving Patient Engagement in Medicine Development and Decision-Making – Challenges and Opportunities

The need for integrating patient engagement strategies early in the medicine development process has sparked widespread discussion in the pharmaceutical industry and beyond. This shift toward patient-centric, patient-empowered healthcare and decision-making has highlighted gaps...
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Is Your Clinical Supply Strategy Ready for EU CTR?

The content in this blog is outdated. For the most recent information on EU CTR, see our latest blog here.   OUTLINING IMP LABELLING CHANGES AND THEIR IMPLICATIONS In May 2014, the European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed,...