Blog: Study Design

Monthly News Roundup - Wordpress

Monthly News Roundup: March 2017

Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and followers. Your likes, clicks, and…

Monthly News Roundup - Wordpress

Monthly News Roundup: January 2017

Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and followers. Your likes, clicks, and…

1-Immunotherapy-Trial-Design-2000px-header-01

What Does Immunotherapy Mean for Trial Design?

It has now been a year since we first posted about immunotherapy on this blog, and several years since the first FDA approval of an immunotherapy treatment for cancer. For anyone paying attention, it’s difficult to avoid the conclusion that immunotherapy is one of today’s hottest topics not only in oncology, but in healthcare at large. Still, the treatment has…

Adaptive-Trails-wordpress

Adaptive Trials: Is Your Study Equipped to Adapt?

Imagine, for a moment, you’re a data manager overseeing a Phase I study. Your endpoints are set, your database built and deployed, and your data collected. Now it’s time to cross your fingers, unblind your database, and hope for favorable tolerability results for the dosage you established. To your dismay, you discover you’ve overestimated the maximum tolerated dosage. What’s worse,…

Monthly News Roundup - Wordpress

Monthly News Roundup: October 2016

Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and followers. Your likes, clicks, and…

Halloween-Infographic-Wordpress

The Horrors of Source Data Verification (infographic)

It was a cold, dark night. The researchers had been moving quickly and were ahead of schedule, unaware of the menace that haunted their clinic – until it struck! Now they’re trapped in the clinic, doomed to lose precious time and funding, prisoners of the specter known as Source Data Verification. This Halloween, we’re here to warn you of the…

Phase-1-precision-medicine-2000px-01

Phase I in the Age of Precision Medicine and Patient Diversity

As clinical research evolves and becomes more refined, the industry is coming to acknowledge a simple truth: that everyone is different. A drug that works wonders for one individual may have little to no effect on, or even be detrimental to, another. Alternatively, the discovery that a treatment is ineffective or dangerous in a small group of clinical trial patients…

Industry-Predictions-infographic-Wordpress

Following Up on Industry Predictions

Late last December, Clinical Leader published an interview with Jonathan Zung, a 20-year pharma veteran who built his career at a number of major companies, including some who have collaborated with Medrio. In it, he offered some predictions as to which clinical research trends he expected to take off in the new year. As we now enter the home stretch…

Patient-Engagement-non campaign wordpress

Another Side of Patient Engagement

The patient engagement craze in clinical research today is largely driven by recent technological innovations. An app allows patients to track their symptoms on their own time, providing clinical data in a passive and convenient fashion. Social media is explored as a new avenue through which to recruit patients for an upcoming trial. These developments have shown great promise in…

First-In-Human-wordpress

Bridging Preclinical and First-in-Human

It’s no surprise that mice are the standard subjects for preclinical research. They are real living things that have real reactions, both positive and negative, to drugs. They’re also not typically associated with the kind of emotional connection that occurs between humans and large pets like cats and dogs. In other ways, however, they are less than ideal. While their…

Respiratory-drug-dev-wordpress

Challenges and Necessities in Respiratory Drug Development

As medical science progresses, our ability to control disease typically improves. Cancer mortality rates have steadily declined over the past 25 years. Not many people in the developed world die from the common flu anymore. Numerous diseases have been eradicated altogether, thanks to vaccines and improved treatment. In this regard, respiratory disease is something of an anomaly. In just a…

Cardiac-Safety-Wordpress

A New Frontier in Cardiac Safety Analysis

Amidst the groundbreaking technological advancements that clinical research has seen in recent years, there are still some areas in which the industry is looking for improvements. One of these is FDA approval rates. Only about ten percent of drugs that enter clinical trials ultimately make it to market, rendering lost the years and, often, billions of dollars spent developing many…

Integrated-Resources Header wordpress

Integrated Resources Uses Medrio to Reduce Study Build Time to One Day

Integrated Resources, an innovative and fast-growing CRO based in Cambridge, Massachusetts, was recently tasked with building a single-ascending-dose Phase I study of a drug to treat a rare disease, Mucopolysaccharidosis type I (MPS I). The CRO is conducting the study with Medrio’s mCore, an all-inclusive product suitable for use in all clinical phases. The study is complex, with two cohorts…

Dian-Data-Manager-2000px-01

A Day in the Life of Diane the Data Manager

160105-Precision-Med-2000px-01

Precision Medicine and its Impact on Clinical Trials

Millions of people around the world take medications that are ineffective and result only in unwanted side effects. Researchers are now turning to the model of Precision Medicine, where physicians and researchers take into account a person’s genes, lifestyle, and environment to develop a treatment plan and prescribe the right medication.  While there have been many advances in the technology…

phase i blog image

Innovative Study Design in Phase I: Adaptive Clinical Trials

Smarter Science, Smarter Study Design We all know that some drugs work better for certain age groups, genders, and other demographic categories. But what if a drug works well for just a tiny subset of patients within an already targeted group?  How do we identify these patients in a big sea of participants? Nowhere is this question more important than…