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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,...
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The Role of Qualitative Interviews in Ensuring a Patient-Centered Approach to Clinical Trials

Author: Morgan Vlad-McCabeClinical 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...
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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...
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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...
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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...
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What Are Unitary Patents and What Do They Mean for Life Sciences Companies?

A Unitary Patent (UP) is a new system for patent protection in the EU that aims to simplify the complex and costly validation and translation requirements. The initiative is expected to have a significant impact on life sciences organizations in the EU by reducing costs,...
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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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International Women's Day: Embracing Equity in Life Sciences

International Women's Day is celebrated annually on March 8 to recognize the social, economic, cultural, and political achievements of women worldwide. The theme for International Women's Day 2023 is "Embrace Equity."Promoting gender equity across life sciences is essential...
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IMP Labeling: EU CTR Transition Considerations

The European Union Clinical Trial Regulation (EU CTR) went live on January 31, 2022. The first-year transition period ended on January 30, 2023, so using the Clinical Trial Information System (CTIS) is now mandatory for all initial submissions of interventional clinical...
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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...
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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...
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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...
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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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3 Automation Outcomes for Pharmacovigilance and Safety Teams

With the continued implementation of artificial intelligence (AI) and automated systems into the clinical process, automated data management systems have helped to alleviate manual burdens on safety teams to focus on more critical tasks. The goal at present is to enhance data...
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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...
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Decentralized Clinical Trials | TransPerfect Life Sciences

This is the second of a two-part series on our recent C3 SummitsTransPerfect 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...
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Lack of Diversity in Clinical Trials: A Conversation

Conversations on Clinical Content (C3) Summit Debrief: Diversity in Clinical TrialsThis is the first of a two-part series on our recent C3 SummitsDuring 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...
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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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Intellectual Property (IP) Strategies to Consider for Life Sciences Start-Ups

Intellectual property (IP) is one of the most valuable assets a life sciences innovator or start-up has. While these companies are often built on the foundations of successful pre-clinical studies, they face a substantial amount of time between obtaining regulatory approvals...
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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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Electronic Product Information – Everything You Need to Know

One of the latest initiatives being spearheaded by EMA is publishing ePI, or electronic product information. In some respects, the pharma industry has lagged behind other major industries in terms of how documentation and critical information is relayed to the end patient....