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...

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...

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...

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,...

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....

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...

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...

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...

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...