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Lay Summary Development: The Oregon Trail of Regulatory Writing

The Oregon Trail: one of the most iconic and cherished computer games of all time, filled with boxy graphics, heartache, and the occasional bout of dysentery. Players took on the role of wagon party leader, navigating the unchartered frontier of the Wild West in 1848—all the...
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Digital Strategies for Patient Recruitment

Patient recruitment is a huge spend in the life sciences. In fact, the market is projected to be worth approximately $30 billion USD by 2030.For life science companies conducting clinical trials, adapting patient recruitment strategies, including utilizing digital campaigns,...
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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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The Benefits of Translation Memory for Low-Cost Markets and Life Sciences Companies

For life sciences companies expanding into new markets and conducting global clinical trials, accurate translation is critical for effectively communicating with patients. Companies are continually looking for ways to reduce costs and turnaround times of translating extensive...
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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...
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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...
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Language Landscape: Latin America

As Latin America (LATAM) is becoming a key market for pharmaceutical companies, the need to connect with the patient population there has increased as well.But is translating your content from English to Spanish LATAM the right approach?As simple as this question may seem,...
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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...
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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...
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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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How Life Sciences Companies Can Detect Adverse Events on Social Media

Pharmaceutical companies have historically relied on email correspondences, company websites, and physician hotlines as adverse event reporting channels. However, the incredibly high usage of social media means it is no longer a channel that can be ignored. Although safety...
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The Summary of Safety and Clinical Performance (SSCP) for Healthcare Professionals and Patients

In 2017, the European Parliament and the Council of the European Union (EU) set a regulatory upgrade on medical devices to strengthen governance structure. This regulation update includes increased oversight of notified bodies, new requirements for transparency and...
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5 Common eCOA Migration Issues

With so many clinical trials now using COAs on electronic platforms, the practice of “migration” (transferring and adapting COAs for electronic use) has become more common than ever. Without careful implementation, one minor deviation can compound across many languages,...
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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....
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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...
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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...
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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...
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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...