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.…

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…

Letting Clinical Trial Patients Do the Talking

In this era of booming technology, principal investigators of clinical trials have tried all sorts of things to overcome persistent patient recruitment hurdles. Their approaches include study websites, outreach through social media, apps helping willing clinical trial patients find appropriate clinical trials, and more. Enrollment rates, however, remain less than ideal, and recruitment continues to occupy a hefty chunk of…

What’s in Store for Zika Virus?

Last weekend, the 2016 summer Olympics wrapped up in Rio de Janeiro. Hundreds of thousands of people from around the world had descended on the city hoping to see the top athletes from their countries snag a gold medal or two to bring home. But as Simone Biles navigated the balance beam and Usain Bolt dashed toward the finish line,…

ER Squared, Founded by an EDC Pioneer, Recommends Medrio for Animal Health

ER Squared is a life sciences consulting firm whose clientele includes, but is not limited to, pharmaceutical, biotech, and animal health companies. ER Squared’s EDC team has experience that spans the 3 decades of EDC systems, including the industry’s first adoption of EDC for 100% of domestic and international clinical trials. So when a client recently appealed to their expertise…

3 Innovative Approaches to Combat Elusive Cancers

Despite the continued advancement of immunotherapy in the fight against cancer, chemotherapy remains the gold standard of cancer treatment. For decades, oncologists have used chemotherapy to trigger apoptosis, a kind of programmed cell death that occurs naturally in the cells of healthy tissue, in cancer cells. But some of the deadliest cancers, including pancreatic and lung cancer, have been stubbornly…

Looking for Time Savings in Phase I

Time sensitivity has long been a defining characteristic of clinical research, and is especially so today. Many of the innovations that have bolstered recent clinical trials – eSource, mobile health apps – are aimed at responding to sponsors’ concerns over study timelines, a concern sparked by rising study costs and growing markets for certain classes of drugs and other treatments.…

The Anatomy of an Ideal Clinical Trial Patient

A good candidate is interested and altruistic Clinical trials require time and energy of those who enroll. Many are repelled by these requirements. Others, however, have personal interests that make them enthusiastic about participating. Some are passionate about medical science, and enchanted by the opportunity to be on the cutting edge of advancements in disease treatment. Some are also motivated…

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 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…

Precision Medicine Through Technology

A number of trends may explain the enthusiasm toward precision medicine in healthcare today. Approaches to clinical trials and doctor-patient relationships are becoming increasingly user-centric. Advances in medical science have shown how to divide populations into treatment subgroups based on certain characteristics. These characteristics are often genetic in nature; precision medicine usually means identifying patient groups based on predispositions to…

A Day in the Life of Diane the Data Manager

Adapting to New Tech in Clinical Trials

The use of new tech in clinical trials is mutually beneficial to both the clinical research and technology industries. It enables the former to make great strides in areas such as efficiency and patient engagement, while tech developers gain access to a large and growing new market. But it also brings challenges. Clinical trials are conducted according to standard operating…

An Update on Apple’s Foray into Healthcare

A decade ago, Apple’s iPhone had yet to be released. Today, a billion people – or almost 14% of the world’s population – have one1. With numbers like these, any product accessible through this revolutionary device has a potentially enormous market. Apple appears cognizant of this truth: confident in the wake of the success of ResearchKit, the company has ventured…

How eSource Cuts Costs

The frenzy of technological development currently taking the research industry by storm has worked wonders in the way of modernizing clinical trials. Much of this, as we discussed last week, entails the utilization of technology developed outside the industry, such as social media, to enhance patient engagement and other aspects of clinical research. But the clinical research industry’s technological savvy…

3 Players in the Mobile Tech Revolution

The incorporation of technology into the clinical research industry has been vast and varied in nature. It encompasses both technology designed specifically for medical purposes, and technology borrowed from the general consumer market and applied to clinical trials. Some of it is employed in the actual medical work of a trial, and some addresses the challenges and tasks associated with…

Immunotherapy and Beyond

Immunotherapy appears poised to usher in a breakthrough in healthcare, and by now, most in the medical community have taken notice. Earlier this year, we posted an overview of this new avenue in cancer research in which we mentioned the recent approvals of the first immunotherapy treatments; in the few short months since then, numerous strides have been made toward…

Clinical Trial Regulations: EU vs. US

Like in many other industries, business relationships in clinical research frequently span international borders. It’s common practice for a sponsor based in one country to conduct a study in another, due either to cost advantage, market opportunity, or other factors. When this happens, though, researchers must be vigilant in becoming familiar with, and adhering to, the regulations governing clinical trials…

Exploring 3 Recent Healthcare Investment Trends

Recent years have seen monumental developments across the healthcare landscape. New technology is rapidly changing the way we treat and study disease. Changes in dietary trends and other lifestyle factors can cause spikes in some diseases and conditions while sending others the way of the dodo. With changing trends in health and sickness come changing investment trends in medical research.…

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