Assessing eClinical Tools for Complex Clinical Trials

It’s a time of great evolution for clinical research. Recent years have seen a major expansion in the size and scope of industry operations. It’s increasingly common for clinical trials to cross borders, oceans, and continents.1 Studies and datasets are bigger, and protocols are more complex.2 All of this makes for a more intricate research environment than previous generations of…

Paper in Clinical Trials: No Trivial Problem

When it comes to data management in clinical trials, paper is not just an inconvenience – it’s a liability. The advent of eClinical technology is not driven solely by the discomfort of working in an office full of stacks of paper. Rather, the eClinical revolution is about data security, timelines, and budgets. The ability of CROs to meet their sponsors’…

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…

3 Ways to Avoid the Hidden Costs of EDC Training and Support

It has now been several decades since EDC was first introduced as a tool for data management in clinical trials. In that time, boosted by continuous developments and enhancements, the technology has grown from a somewhat esoteric alternative to paper to a standard considered essential throughout most of the industry. Without thorough and comprehensive training and support resources, though, it…

Saving Time with an Efficient EDC Interface

Over the years, the clinical research industry has developed various methods for accessing crucial time savings. Much has been published, for example, on strategies for enhancing patient recruitment, a process that is notoriously vulnerable to delays. EDC, of course, is another major source of these savings. Range checks, for example, allow users to correct errors immediately; once data is transferred…

What Does the Chan Zuckerberg Biohub Mean for EDC?

Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. Most recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is…

eSource from the Site Perspective

With the necessary technology and the support of the FDA in place, the eSource revolution is charging forward. Researchers are marveling at the efficiencies eSource creates as its adoption becomes more widespread. While one may expect that a new, groundbreaking technology will initially be met with some resistance from the industry it affects, eSource has already proved highly effective in…

Monthly News Roundup: February 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…

How ARG Used an API Integration to Meet a Challenge Head-On

One of our favorite things to see, here at Medrio, is a customer combining our eClinical offerings with their own savvy and ingenuity to enhance their operations and overcome challenges. So when Atlantic Research Group, a CRO and longtime Medrio customer, used our application programming interface (API) to integrate Medrio’s EDC with the interactive response technology (IRT) solution provided by…

5 Ways EDC Reports can Protect your Timelines

The adage “time is money” is as pertinent to clinical research as to any other corner of the business world. The longer a study drags on, the bigger its price tag becomes. Study timelines can be a source of much anxiety for researchers, creating the markets for time-saving innovations like EDC, eSource, and risk-based monitoring. Recent trends are not easing…

eSource PRO: A Phase I Patient Engagement Tool

A major driver of patient recruitment hurdles in Phase I clinical trials could be described as the perceived distance between researchers and subjects. Researchers can appear only interested in mining patients for data, unconcerned with any health risks posed by a compound whose safety profile has yet to be determined. This perception is not-so-affectionately referred to as the “guinea pig…

Tackling Today’s Data Security Demands

Across our society, technology is delivering enhancements and efficiencies to our day-to-day lives at an exponential rate. It has also, however, brought challenges, as regulations designed to establish ethical standards for the use of that technology have struggled to keep up with the pace of innovation. An article in MIT Technology Review notes how this challenge has manifested in areas…

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…

A Day in the Life of a Clinical Research Associate

It’s another busy day at work for Carrie the Clinical Research Associate. She’s got data to review, reports to write, and lots of other important tasks on her agenda. Luckily, she’s got Medrio supporting the studies she works with and making her job more convenient. Let’s shadow Carrie at her workplace to get a sense of a typical day for…

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…

3 Early Obstacles in Phase I, and How to Address Them

Anyone with an involvement or interest in clinical research is likely to be aware of the challenges sponsors face in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall…

Making EDC Accessible to Everyone

Electronic data capture for clinical trials is a multi-billion-dollar industry1 that has brought demonstrable benefits to all phases of clinical research. Still, the portion of clinical trials collecting and managing their data on paper is too large to ignore. As recently as 2015, Open Health News reported that less than half of all new clinical trials were using EDC. And…

Monthly News Roundup: December 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…

How to Keep Headaches Small as Phase I Trials Get Big

Statistics suggest that Phase I clinical trials, while by no means free of challenges, are more manageable than later phases. They tend to take less time and cost less money; the drugs they test have a comfortable 70% chance of moving on to the next phase.1 These figures are a reprieve from some of the realities that make Phase I…

Addressing Safety in Phase I

The purpose of a Phase I trial is to test a new drug or treatment on human subjects for the first time in order to determine its safety, evaluate side effects, and ascertain the correct dosage level. It is important to ensure that each drug or device being tested is safe before moving forward with the next phase. Unfortunately, it…

Looking Back: 5 Stories from 2016 (infographic)

2016 has been a big year for clinical research. There have been challenges and setbacks, opportunities and advancements. As the year draws to a close, we thought we’d look back on some of the events that have made it such a memorable one, as well as take stock of where we are as the new year approaches. When all is…

Why Real-Time Edit Checks are More Important than Ever

Modern clinical trials can be sprawling networks of clinics, people, and data. They can span borders and oceans. They utilize various communication channels. And they involve a multitude of interested parties, including patients, researchers, and other staff. In undertaking such complex trials, in can be difficult to provide sufficient oversight to ensure the quality of the most important and fundamental…

Monthly News Roundup: November 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…

Patient Recruitment in the Age of Immunotherapy

The persistent challenge of patient recruitment is nothing if not well-documented. It has appeared in countless journals and blogs; it exists across all phases of clinical research. Some of its causes are most common in, or even unique to, Phase I trials. The absence of medical necessity among Phase I healthy volunteers leaves little motivation to participate beyond monetary compensation,…

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,…

Snapshot: 2 Challenges in Research Today

The progress of new drugs from clinic to market faces numerous challenges that organizations across the industry work tirelessly to address. As an EDC company, Medrio, for example, strives to eliminate inefficiencies in data management that can hinder clinical trials. In this post, we thought we’d take a sample of some of the other challenges facing researchers today. Why are…

Beating Connectivity Gaps with Offline Data Entry

Like it has with most aspects of our lives, the internet has revolutionized the process of capturing and managing data for clinical trials. Electronic data capture (EDC), which has provided a reliable and manageable alternative to paper for the storage of patient data, has begun to shift toward cloud services, significantly expanding researchers’ abilities to share and access clinical data.…

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…

Taking On a New Competitive Landscape in Phase I

Medical discoveries, major investments from the private and public sectors, and growing markets for certain treatments have taken the engines of drug development from a purr to a roar. But like any healthy industry, a byproduct of boom times is intense competition. Some CROs have, to an extent, insulated themselves from this competition by focusing on niche markets based on…

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…

Educating Tomorrow’s Clinical Researchers

A drug’s journey from proof of concept to FDA approval is a years-long, far-reaching process in which healthcare, business and government each play important roles. For aspiring clinical researchers hoping to navigate this sprawling field, there’s certainly a lot to learn. We thought we’d take a look at a pair of initiatives educating students in healthcare and pharmacology in the…

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…

How Dictionary Coding Can Enhance Phase I

Many of the challenges in clinical research stem from the experience gap between researchers and their patients. The research teams who conduct clinical trials do so with years of specialized education and training under their belt, while most participants journey through the patient experience as laypeople. This disparity creates a mandate for the development of strategies and tools that can…

Monthly News Roundup: September 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…

At Ancillarie, Medrio Makes Study Build Easy, Even for New Data Managers

It’s not often that two clinical data managers who are years apart in their experience feel equally at ease during a clinical trial. But this is precisely what took place at Ancillarie, a support services company that has been serving pharmaceutical and biotechnology companies since 2012. In 2013, seeking an electronic data capture (EDC) system to catalyze their clinical research,…

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…

3 Rockin’ Recruitment Platforms

Recruitment practices have evolved a great deal, becoming increasingly tech-oriented over the last few years. Here are three recently-developed online tools researchers are using to keep their enrollment levels high.

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…

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…

New Potential Leads to New Challenges in Pharma Today

Almost a quarter million clinical trials worldwide are registered on the database ClinicalTrials.gov. Today’s top treatments and diseases are seeing billions of dollars in investments from venture capitalists, governments, and others. Recent outbreaks of infectious diseases like Zika virus and Ebola have stoked demand for more, and faster, drug development. All of this points to boom times in clinical research.…

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