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.…

A Look at Voluntary Reporting Practices

It’s standard practice for governments around the world to impose reporting requirements on clinical trials conducted in their countries. And while the regulatory apparatus of one country may differ from that of another, there is a common thread throughout the West: the occasional failure of clinical trials to report their results is well-publicized. While media coverage of the issue often…

The Growing Trend Toward Patient Engagement

The global economy, catalyzed by technology, is becoming increasingly consumer-centric. Social media and mobile applications are putting the ball in the customer’s court across industries ranging from transportation to legal counsel to hospitality. The clinical research industry has its analogy to this trend in the rise of patient engagement. A recent eyeforpharma report notes that the vast majority of pharmaceutical…

Medrio Quick Facts

As eClinical data management continues its march toward becoming the norm in clinical research, the landscape becomes increasingly populated with companies offering EDC. It can be difficult for EDC providers to stand out among broadening competition. Here at Medrio, we’ve grown with the times and created a model that has kept us unique as the industry develops. Here’s a quick…

A Bird’s-Eye View of a Clinical Research Nurse

Registration and Publicity in Phase I

About a month ago, we published a post examining the friction, in clinical trials, between the demand for transparency and the protection of confidentiality. Regulators recently published guidelines for reporting the results of European clinical trials; in the U.S., there have been calls for improved compliance with reporting requirements1. This is a discussion that often focuses on the back end…

Coverage Policy: Boosting or Busting Clinical Recruitment?

There are numerous obstacles that stand in the way of patient recruitment for clinical trials. This is neither a secret in the clinical research industry, nor is it difficult to understand. After all, at face value, being the subject of an experiment studying the unknown effects of a controlled substance may not, frankly, sound so appealing. Efforts to address this…

A Potential Breakthrough in Neurological Research (Infographic)

In recent years, neurodegenerative diseases have gained prominence not just in the scientific community, but in pop culture. Films like Concussion and Still Alice investigated the subject from the perspectives of researchers and patients; actor Seth Rogen has become a high-profile advocate for Alzheimer’s research, even taking the cause before Congress in 20141. This attention is not unwarranted. Neurodegenerative diseases…

eSource: Delivering the Knockout Punch to Paper

As the eClinical industry thrives, it’s easy to imagine the wisdom of EDC catching on and a new, paperless norm being established. After all, the burdens of paper-based data management–high cost, slow study build, and cumbersome SDV, just to name a few–have been well-documented on this very blog. With the superiority of EDC so far beyond dispute, shouldn’t paper be,…

Talking eSource, Product, and Rock & Roll at mSquared 2016

It has now been a week since Medrio’s 2016 mSquared user conference in downtown San Francisco, where 79 customers joined Medrio staff for a multitude of fascinating presentations and discussions. The program included speeches and demonstrations from a number of our customers, including some of our top Phase I customers, who, combined, have over a dozen active or completed Phase…

Transparency vs. Confidentiality

With several exceptions, the FDA requires that studies of drugs and devices be registered, and their results reported, by their sponsors or principal investigators1. But there is often a tug-of-war, in the clinical research field, between researchers who value confidentiality in trial results and governments and advocacy groups who demand transparency2. The issue is complex, with various interests coming into…

The Rise of eClinical: What Opportunities Are Presented?

In December of 2014, Sandra Freeman, writing for Applied Clinical Trials, predicted that 2015 would prove to be the year of eClinical, with a reduction in paper usage and a rise in eSignatures resulting in faster study start-up time1. According to Globe Newswire, by 2020, eClinical will be a nearly $6 billion-industry2. All this points to what is, for many,…

Can Technology Allay Safety Concerns In Phase I?

The FDA reports that 70% of drugs in Phase I trials ultimately make it to later phases of clinical research1. This number may look impressive until one remembers the primary purpose of a Phase I study: to determine if a treatment is safe and well-tolerated in humans. If 70% of drugs tested in Phase I move on to Phase II,…

Zika, Malaria, and Pregnant Women in Clinical Trials

We recently published a post exploring the need for increased diversity among participants in clinical trials. In that post, we cited certain demographics, including African Americans, the elderly, and more, as some of the most underrepresented in clinical settings. But there is one demographic that we didn’t mention, one whose frequent exclusion from clinical trials could have significant implications for…

Rare but Meaningful Efficacy Findings in Phase I Oncology Trials

A Phase I trial for a cancer treatment is, almost by definition, emotionally loaded territory. Unlike other Phase I trials, which test a new treatment on healthy volunteers, cancer trials involve patients who are presently battling the type of cancer the treatment is designed to target1. What’s more, a typical participant in these trials has already exhausted all standard treatments…

The Importance of Diversity in Clinical Trials

In the world of clinical trials, uniformity can be a dirty word. From blind use of placebos to dosage variation, incorporation of variables is an essential part of any study. But it’s important for researchers to ensure variety not just in the drugs being tested, but among patients as well. A lack of diversity can lead to skewed data, and…

The Potential Impact of 3D Printing on Pharma

In August of last year, the FDA made history by approving the use of 3D printing technology to produce pills. A 3D printer can bind particles of a powdered form of a drug using miniscule quantities of liquid, resulting in a tablet that is highly porous and therefore dissolves quickly and easily in water. Aprecia Pharmaceuticals, which strives to improve…

A Bird’s Eye View of a Clinical Research Associate

Preliminary Results from Apple’s ResearchKit

We are currently living in an age in which it’s nearly impossible to imagine going anywhere without your smartphone. While you are carrying your phone around, whether in your hand, pocket, or purse, it is constantly collecting and tracking data. This data, which has an immense potential to impact medical research, is not being used and is rarely even viewed.…

The Immunotherapy Revolution

Immunotherapy characterizes the most promising cancer treatment approach since chemotherapy was developed in the late 1940s. While the potential that immunotherapy holds has been understood for more than a century, it is only recently that multiple agents for the treatment of cancer have been approved.1 The last few decades have shown an advancement in immunotherapy, but newer types of immune…

Harnessing the Power of eSource for your Clinical Trials

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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…

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