Medrio Blog

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, it can be difficult to provide sufficient oversight to ensure the quality of the most important and fundamental component of clinical research: the data entered. To prevent lapses in data quality, many EDC companies offer edit check functionality, whereby their software recognizes errors and fires queries when they arise. But ensuring data capture quality is only part of the solution; in today’s competitive research environment, in which there’s more pressure than ever for researchers to keep timelines down and stay within budgets, it’s also essential to do so as fast as possible. That’s why the ability to perform real-time edit checks, rather than having to wait until a designated moment to view and address queries, can make or break a study’s chances of success, elevating one of the clinical trials challenges. Indeed, this ability can be hard to come by. Safeguards of data quality in an EDC typically involve an established range of acceptable data for a given data point; the system fires a query when a piece of data falls outside of that range or isn’t entered. But most EDC companies don’t allow access to those queries until after data is submitted. This means that site staff may not recognize data errors on a form until after they’ve completed and saved it. To address the query, users have to reopen the study and backtrack in order to correct the error. They may be forced to consult their source documents again or to scroll through a lengthy form in search of the query. Over the course of the study—especially one involving long and complicated forms—the time this requires can add up. Recognizing the various drawbacks to this system, Medrio allows for real-time edit checks, so that queries fire the moment an erroneous piece of data enters the system. Users can rest assured, as they conduct their research, that no data errors lie waiting to cause headaches once a form is closed. Why Now? Producing sound data has always been important in clinical research, as has the ability to do so with efficiency. But until recent years, achieving these objectives was less of a challenge. The average clinical trial was smaller and more centralized, making it easier to oversee data entry and keeping the chance of error to a manageable level. Today, larger, farther-reaching, and more complex decentralized studies are growing in popularity among sponsors. A typical study now includes numerous sites across numerous countries, as well as large research teams whose members often work remotely from one another. The sheer quantity of data collected in such complex trials can be overwhelming. It also creates a much higher risk of human error during data entry than previous generations of clinical researchers, whose studies were smaller and more centralized, needed to manage. This, combined with recent regulations aimed at ensuring data quality that has arisen as a result, create a market for an EDC feature like real-time edit checks that can guard against data entry errors without allowing them to compound or delay a study. Current market trends make the case for real-time edit checks even more compelling. Not only are trials getting bigger and more complicated, but they’re also getting more competitive, as well. Increased demand for clinical trials has raised the stakes of competition among sponsors, with effects rippling out among CROs, sites, and other involved parties. And as the cost of drug development continues to rise, budget concerns add even more pressure. Researchers today are racing to get their products to the FDA like never before, both to beat the competition to market and to minimize the impact of their studies on their pocketbooks. The time savings created by real-time edit checks make it easier to accomplish these goals. In light of these conditions, clinical research today is ripe for an EDC tool that can not only detect data-entry errors that site staff may have missed but seamlessly integrate that detection into the research process. From increased error risk, new regulatory compliance burdens, and a higher-than-usual premium on efficiency in an already time-sensitive industry, it’s something of a surprise that only a few EDC providers offer such a tool. Medrio’s real-time edit checks functionality is just one of the many features that make the software uniquely simple, intuitive, and, most importantly, well-positioned to help researchers keep data quality up and timelines down in a competitive industry. References:

We comment a lot, on this blog, on the trends influencing the direction of clinical research and the eClinical technology industry. One trend that has become an especially prominent topic of water cooler conversations today is recent acquisitions in the eClinical space. There have been a number of high-profile cases in recent years of technology giants hoping to edge their way into the life science field by acquiring an eClinical software provider. Opinions and reactions abound when it comes to these things. Many will point out the positive effects of such acquisitions: for the acquired company, stock boosts for employees, more stability, and a growth infusion are just some of the benefits people cite. And they’re right to do so. But when the ink dries and the hands are shaken, the customers of those companies – the people on the ground who rely on fast and easy software in their pursuit of life-saving medical breakthroughs – may find themselves in a strange and unfamiliar landscape. All of this raises the important question of how data managers and site staff should react when their provider announces an acquisition. Customers of acquired eClinical providers can take comfort in the validation and stability that such acquisitions bring. But there are certain aspects of recent acquisitions in the eClinical software industry that have some people scratching their heads. 1. The parent company is an outsider In recent cases, the company acquiring an eClinical provider is not, itself, in the eClinical space. This means only a fraction of the parent company’s product development will go toward improving the eClinical platform that users have come to depend upon, leading to a slower and less robust product roadmap, with fewer resources dedicated to ensuring speed and ease of use for eClinical users. 2. Turnover is inevitable An unavoidable byproduct of corporate acquisitions is significant employee turnover. Many of the people who helped build the acquired company and who understand its strengths, weaknesses, and the unique needs of its customers move on, leaving those customers to work with a whole new cast of characters unfamiliar with the nuances of each project. 3. Doing business becomes a chore The bigger a company gets, the harder it can be to connect with support staff who understand and care. Moreover, with acquisitions, customers can find themselves suddenly facing new and more complex pricing structures from the parent company looking to recoup their investment. The bottom line: clinical researchers who are trying to focus on treating disease and saving lives are suddenly mired in financial and logistical headaches. At the end of the day, clinical researchers need an eClinical solution that delivers the ease of use and functionality to get their studies up and running quickly and create a smooth path to database lock. Along the way, they need to know that they won’t get bogged down by unnecessary complexity, out-of-reach support resources, or opaque cost structures. Adding uncertainty and a diminished customer focus only makes the situation worse. After all, lives are at stake – there’s little time to waste on logistics. While the eClinical acquisitions making headlines in recent years do offer some reason for excitement, the customers of acquired companies should consider what the impact could be on their ability to answer the call of public health.

“We’re faced with an unprecedented challenge in the time of COVID-19, but our collective determination and expertise enabled us to execute. Detecting sepsis early is imperative for effective treatment and would enable the clinical team to ensure that the right patient receives the right level of care at a time when resources are stretched and every moment counts. Achieving FPI in only seven days is a huge feat, and all parties involved should be extremely proud of their efforts,” said Ajay Shah, Ph.D., Co-founder, and CEO of Cytovale. A typical study with Medirio can get FPI within 6 weeks compared to the industry average of 12 weeks, due to the programming free drag and drop interface of our EDC system. Speed coupled with a flexible system puts you in the driver’s seat allowing changes on your timeline without coding or extra fees. From ICH/GCP and 21 CFR to GDPR and HIPAA, our customers are equipped with easy-to-use tools allowing them to focus on the trial with complete confidence that their data is compliant and secure. As organizations transition to more virtual operations, our hybrid and decentralized solutions are ready to help you meet accelerated timelines and changes when you need them.

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, had you been able to access the database during the study, you could have discovered this shortly after deployment and made protocol modifications that would have saved you time, money, and energy that has now been spent in vain. It’s an outcome that would be a shame to repeat.  You resolve to empower yourself to make those modifications by taking an adaptive approach to trial design for future studies — and to invest in the tools that make adaptive trials possible. Adaptive Trials and Electronic Data Capture (EDC) A traditionally designed clinical trial is, by nature, a roll of the dice. Once a database is deployed, researchers can’t make many changes until the end of the study. In adaptive trials, however, databases can be unblinded while the study is in progress so that researchers can make changes to certain endpoints as needed, creating the potential for substantial time and monetary savings.  But while more researchers than ever before are investing in Electronic Data Capture (EDC) software to enhance the efficiency of their research, many EDC companies aren’t effective in accommodating adaptive designs and are thus limited in offering the efficiency those designs make possible.  Some EDCs, for example, when a mid-study discovery in an adaptive trial calls for a modification of the study’s endpoints, require researchers to take the entire database offline, perform complex modifications upon it, and ultimately push it live again. The time and resources spent on such an endeavor negate much or all of the efficiency of an adaptive design. Adaptive trials are most common in Phase I, but some pharma experts see increasing adoption of the approach in Phases II and III.(1) As the trend spreads across the clinical research landscape, the EDC companies best positioned to serve the needs of the industry will be those that are capable of managing adaptive trials with efficiency.  Researchers taking an adaptive approach to trial design will benefit from seeking out an EDC that provides them with the ability not only to make mid-study changes but to do so in a surgical and non-disruptive manner.  Medrio allows users to make select changes to select forms while a study is in progress, as opposed to the wholesale redesign of a study database that is required elsewhere.  Users can also test their changes in a development environment separate from the ongoing study, instead of taking the entire study offline until the changes are finalized and deployed. The ability to make mid-study changes is one thing; the ability to do so without delaying the study or, even worse, starting from scratch will allow researchers to conduct adaptive clinical trials without paying for it in lost efficiency.  Download Our eBook: What Small Teams Need in a Strategic CDMS/EDC Partner Why Phase I? Given the long-term impact that study design can have on a treatment’s success, the degree to which an EDC company can accommodate adaptive trials is an important consideration. There are, after all, reasons why adaptive designs are particularly prevalent in Phase I trials.  According to adaptive trial experts, one of those reasons is that the ability to optimize the results of a Phase I trial significantly increases the chances of success in the next phases of a drug’s development.(2) Modifying certain aspects of a study database as needed during an adaptive trial is one of the most effective ways of achieving that optimization. The question, therefore, of whether an EDC is robust at accommodating adaptive trial designs is one that can have reverberations from Phase I all the way to FDA submission. Researchers would be wise to consider this question thoroughly before making an EDC selection. References: