Thought Leadership
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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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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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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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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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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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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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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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A Comparison Between Document Management Systems (DMS) and Component Content Management Systems (CCMS) for Pharma

CHOOSING THE RIGHT OPTION FOR YOU AND YOUR BUSINESS NEEDS Global pharma companies produce and manage a lot of content that is complexly intertwined. To mitigate risk, ensure patient safety, meet regulatory compliance standards, and reduce cycle times for faster drug-to...
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An Unlikely Perfect Pairing: Life Sciences & Translation

What Is Life Sciences Translation? Let’s first define the term “translation” within a life sciences context. Life sciences translation is the adaptation of clinical documentation and MedTech materials across different languages. While the concept may seem relatively simple, it...
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Does a One-Stop-Shop Global Translation Provider Truly Exist?

Within the global translation market, there are over 200 global language service providers (LSPs), each reporting annual revenues larger than $1 million. Collectively, the 2020 revenue of all 200 companies equates to approximately $8 billion. All of these LSPs have...
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3 Translation Methodologies for Life Sciences Documentation

Translation is a complex endeavor, particularly in life sciences. Translation workflows, from receiving the document to delivering the final product, have multiple steps that must be followed with utmost accuracy.There is no one-size-fits-all model when translating clinical...
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5 Ways to Increase Diversity in Medical Product Development

Over the past decade, there has been a critical push for more inclusive clinical trials. Many regulatory bodies, including the US Food and Drug Administration (FDA), require clinical trial data to ensure a medical product’s safety and efficacy prior to approving new treatments....
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How TMF Study Owners Can Provide Better TMF Management

Successful trial master file (TMF) management requires constant and careful attention to each process, procedure, and guideline. This ensures a TMF is completely up-to-date, compliant, and ready for inspection at a moment’s notice. You know that maintaining high TMF quality is...
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Preparing Compliant eCTD Submissions in Asia

In May 2015, the US FDA published final and binding guidance requiring submission within 24 months of certain Common Technical Documents (CTDs) in an electronic format. This was ratified in 2017 and subsequently revised in February 2020 (Rev. 7). Currently, other notifying bodies...
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Preparing and Publishing a Scientific Manuscript

If you’re preparing to write a scientific report for a peer-reviewed journal, it’s critical to have a detailed plan before beginning the first draft of your manuscript. Following the correct format and general guidance for manuscript writing is a good start, but there...
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How to Choose and Implement a CTMS

The clinical development landscape is awash in technologies that automate everything from subject randomization (IVR/IWR) and subject study assessments and outcomes (EDC, ePRO) to trial master file (TMF) solutions.If you are like many emerging small to mid-sized biotech and...
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Driving Fundamentals: Ensuring an Efficient Clinical Research Process

My daughter is learning how to drive. In the U.S., driving a car is almost part of our DNA. For most of us, we learn to drive in our late teens and then continue to drive for the majority of the rest of our lives. At some point, we sort of forget we had to learn how to do it. As...
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What Is A TMF Certified Copy?

Legendary designer Coco Chanel famously said about fashion, “If you want to be original, be ready to be copied.”When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors...
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Practical Applications of Machine Learning for Clinical Trials

In this blog, you’ll learn more about the business cases for machine learning that offer a clearer path to inspection readiness, as well as greater efficiency, timeliness, and quality in the TMF. You’ll understand the challenges that can be solved by applying machine learning to...
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Say “Yes!” to Mobile-First CTMS

A lot can happen in 25 years. In that time, we went from landline internet and bulky personal computers to ever-connected mobile devices. In that same time, nearly all global businesses adopted Microsoft Office for numerous daily tasks. Word, PowerPoint, Outlook, and of course...
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Clinical Research 2020: A Trial Interactive Reflection on Resilience and Community

To put it mildly, 2020 has been a time of adjustment. We were taken out of our comfort zones, professionally and personally, and we had to find productive ways to live in the COVID-19 pandemic present. In short, this crisis changed all of our plans, putting many trials on hold or...