Medrio Blog

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Virtual, Decentralized, Hybrid: What’s the Difference?

The clinical trial landscape is ever-changing. New technology and innovation have changed the way we look at clinical trial design. While we can agree that the recent focus on patient-centricity has been a long time coming, the industry as a whole has struggled with agreeing on how to shift trial designs to be more patient-centric. There are a lot of confusing terms circulating as they relate to clinical trials — virtual, decentralized, hybrid, remote, siteless — the list goes on and on, but what do they mean from a practical standpoint? Can the industry be expected to switch from a traditional clinical trial model to virtual clinical trials overnight? The answer is this would be wildly impractical, not to mention improbable. The process to move to a more remote or virtual environment takes planning, restructuring, and most of all time. In the wake of COVID-19, we’re learning the impracticalities of making a virtual trial a reality overnight. So what is the solution when faced with a global crisis? Decentralization. You may be thinking that virtual and decentralized are one and the same, but I believe the definitions are a bit more fluid. While the terms virtual and decentralized have been used synonymously, hybrid trials have also been described as a decentralized trial. I view a virtual trial as being siteless and fully remote, meaning no or extremely limited physical contact between clinicians and patients. In this model, patients are utilizing remote eConsent, telehealth, and ePRO/eCOA. Researchers and clinicians are using telehealth to communicate with patients, direct capture to record patient observations, and an Electronic Data Capture (EDC) system to store the data. With a decentralized trial model, I believe there is a bit less rigidity to the definition. I view decentralization as a flexible path. Decentralization is ideal for sponsors and CROs who want to be patient-centric and improve data quality, but aren’t prepared to move to a completely remote model. I like to think of decentralization as a bridge between traditional models and virtual models — a hybrid approach. Decentralization is ideal for transitioning into a virtual environment and while used synonymously with “virtual” nine times out of ten a decentralized trial is what we refer to as a hybrid trial. A hybrid model utilizes any combination of traditional and virtual trial elements. The Medrio Difference We recognize that the variety of terms and the nuanced meanings behind them can be confusing and overwhelming. It’s hard enough adopting new technology, why add confusing terminology into the mix? That’s why we developed our Decentralized Clinical Trials Solution to meet the needs of traditional, hybrid, and virtual trials. Our technology is flexible and adaptable to meet your needs. We also recognize the time and effort involved in the decentralization process. Our professional services team is equipped to provide guidance throughout your process, whether it be moving from paper to electronic data collection or from in-clinic to remote patient engagement. Additionally, our Global Support team is on call 24/7 ready to answer your questions. Medrio’s Support team really goes above and beyond the call of duty, always putting our customers first. But don’t take my word for it, hear what our customers have to say.

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Why Are Real-Time Edit Checks Important in Clinical Trials?

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:

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What to Keep in Mind When Your eClinical Provider Gets Acquired

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.

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How did Medrio Achieve FPI in Seven Days?

“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.

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Patient Diversity and eClinical Vendor Selection

Regulators and many in the clinical research industry emphasize patient diversity, but how do contract research organizations (CROs) and sponsors achieve it? The US Food and Drug Administration (FDA) recently released its Drug Trials Snapshots for 2019 – a document that shares the demographics of clinical trial participants in approved clinical trials. Here are some key findings: More women are participating in clinical trials. Of drug trials that gained approval last year, 72% of participants were female. Diversity has decreased from 2018. Last year, only 9% of participants were Black or African American, 9% were Asian, and 18% were Latino. While these demographics shift from year to year, patient diversity is a critical is a growing trend and crucial aspect of successful research. To adequately prepare for the future and to best serve populations in need, we encourage you to consider this during eClinical vendor selection. Let’s take a deep dive into patient diversity’s significance, main obstacles, and see what eClinical features can help: Why is Patient Diversity Important? For study results to show safety and efficacy for all people, participant demographics need to mirror the country’s population. For example, when the US FDA approves a treatment, it can be prescribed to people of all ages, genders, races, and ethnicities. Some diseases, however, disproportionately affect specific demographics. There is also growing evidence that drugs have different effects on different populations. With the rise of personalized medicine, one-size-fits-all medicine is becoming a thing of the past. On top of this, more effective treatments for all communities means more safety and overall better public health. Regulators are also starting to demand it. In 2015, the FDA began publishing the demographics of clinical trials for newly approved drugs. Although the organization can’t set official guidelines for age, gender, and racial representation, they have called out the lack of diversity. Enrollment should reflect the patients most likely to use a medical product. Therefore, better diversity can improve your treatment’s chances of regulatory approval. Why Is There Such a Big Clinical Trial Participation Gap? One of the main reasons is the fact that many are unaware that clinical trials exist. Even though many organizations are harnessing new technology to increase awareness, connecting participants to trials is a great challenge. Then, there are logistical and financial challenges. Data shows that people making less than $50,000 per year are significantly less likely to participate in clinical trials. Traditional clinical trials often require participants to take time off off work, commute long distances to sites, and find childcare. This means that those in rural areas or with lower incomes will likely not consider joining a traditional study. Distrust of the health care system and clinical trials also exists for some groups. Because clinical trials are inherently risky, building trust with the target demographic of your study is essential to research success. What Can Improve Patient Diversity In Clinical Trials? Improving awareness is a fundamental way to help boost patient diversity. Research shows that patients are more likely to enroll in trials if their health care provider recommends it. Many have also turned to social media to get the word out. From an eClinical perspective, decentralized clinical trial capabilities can greatly expand inclusivity – and you don’t have to go entirely virtual to accomplish this. Reliable tools like ePRO can reduce patient burden by allowing participants to provide patient-reported outcomes from home. Participants will spend less time traveling to sites and avoid needing childcare or time off work. eConsent can also help in efforts to boost trust and engagement. Although this tool is relatively new, it’s proven tremendously useful in increasing patient comprehension and patient retention. Lastly, even in developed countries, the internet can be spotty when outside of urban areas. Having Direct Data Capture (DDC) that can collect data offline and sync directly with the EDC once connectivity can expand your data-capture capabilities and give you more flexibility. The benefits of boosting patient diversity are huge: more people will benefit from your discoveries. Also, your results will be more representative and relevant to all segments of the population. For us at Medrio, we’ll continue doing our part to support patient diversity in clinical research with our EDC and eSource suite. By increasing access to clinical trials for all, we can have a more substantial impact on public health and health equity.

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eClinical Customer Service

With so much riding on the outcome of your research, you want to have reliable eClinical customer service behind you. When evaluating eClinical service providers, customer support may not be the first thing to come in mind. You may be more focused on the essential features you need to suit your study. However, beyond the careful evaluation of the functionality you need, it’s wise to consider the people behind your software. No matter the type of research you conduct, you want smooth trials. Proactive training and quick problem resolution can help you meet this goal. One of our Customer Success Managers, Lisa Charlton, sums up Medrio’s view of customer success in a recent interview: “Customer success is good data with minimal pain points. No clinical trial will be without problems, so a responsive support system with proactive training is essential to a successful model whether you’re a site, sponsor, or CRO.” We’re proud to have supported more than 4,500 studies and have a 98% satisfaction rating. As clinical trials grow worldwide, and more eClinical services emerge, it can be challenging to select best-fit solutions. Let’s look at several things you should look for from a customer service perspective: Proactive eClinical Customer Service is Best “I strive to form strong, collaborative partnerships. I ensure customers take full advantage of our software and utilize it in the best way possible to achieve their business objectives. Also, one of my most important responsibilities is to serve as a customer advocate — making sure their voices are heard.” — Laurin Willetts, Medrio Customer Success Manager Just like the old saying, “An ounce of prevention is worth a pound of cure,” you want service that takes preventative action. For example, one of our clients recently faced a tough challenge: they had to go live less than two weeks after new software implementation. They had scheduled in-person training in Perth, Australia; however, they were also able to begin training immediately via WebEx to transition smoothly despite the time crunch. Also, there’s nothing worse than getting a piece of technology, having problems, and then waiting for customer support. Once you’re up and running, you want to move forward knowing your detail-oriented customer support team will be available 24/7 to resolve any issues quickly. Success Story: Advance Research Associates Finds a Strong eClinical Partner in Medrio Customer Success Managers with Industry Experience is a Huge Plus Having customer support managers who’ve walked in your shoes can add tremendous value. Check to see if your eClinical service provider’s team has staff who’ve worked in the industry and have in-depth regulatory knowledge. Their firsthand insights into your challenges and obstacles can go far beyond average support. We’re proud to have several Customer Success Managers on staff with extensive backgrounds in clinical research. Our Customer Success Manager, Lisa Charlton, holds a Ph.D. in Biology and consulted on clinical outcome assessments and eCOA implementation. When we sat down with her recently, she told us, “I think the eClinical companies that will be most successful are the ones that address the personas of the site, data manager, and patient in a timely and cost-effective manner. She adds, “I learned firsthand from sponsors about obstacles at their sites — a central focus of my career has been understanding customers and helping to solve their problems.” In another recent interview, we sat down with Laurin Willets, a customer success manager who shares her personal experience using Medrio in clinical trials. Managers like these can help you with highly detailed questions that save you time and frustration when working through your trial. Make Sure They Can Take Compliance Concerns Off  Your Plate With global regulations — from Asia to Europe to North America — rapidly shifting and becoming more strict, there’s a lot to keep in mind when it comes to compliance. Be sure to check that your software is prepared for all major upcoming regulatory shifts, like MDR. But beyond the software, make sure your customer support team can answer specific questions you might have about compliance. This team should inform you of approaching regulatory changes, and the software should do the work for you without you having to worry. For example, our eClinical suite is ready for any changes to global compliance well before any changes go into effect. It’s Helpful to Have a Unified Support Team Many eClinical service providers offer a variety of tools. For example, we provide EDC, direct data capture (DDC), ePRO, and eConsent software. Check that your customer support team has been trained on all tools. It’s much simpler to deal with one team for all services, instead of having disparate support teams for each tool. For example, all our customer success staff are trained on all software. You can go to one place for all your questions throughout your study. Many other eClinical support providers have different teams for different tools due to their size or because of acquisitions. This means you would have to talk to various support teams, and no one person could help facilitate your trial from end to end. Customer service shouldn’t be overlooked when deciding on an eClinical service provider. Part of having safe and reliable software is a knowledgeable and proactive team behind it to facilitate your productivity. For us at Medrio, we’re proud to have industry-leading customer support. We will continue doing our part to provide researchers with the tools to continue making breakthroughs in public health. Your success is not only ours but also the patients who need your work.

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5 Considerations When Choosing an eClinical Platform

Digital technology is now completely intertwined with our lives. It’s transformed the way we communicate personally and professionally and has revolutionized industries from business to banking to transportation. The clinical research industry may have been cautious about going digital, but researchers need to be aware that new tech, such as an eClinical platform, will play a more significant role in the future: With this shift, new Electronic Data Capture (EDC) and Direct Data Capture (DDC) solutions have emerged to support and facilitate research. This variety has many positives and provides more assurance that researchers will get their needs met. Still, too much choice can also potentially confuse and complicate the selection process. Since lives are often at stake when it comes to clinical research, best-fit solutions are a must. Take a look at 5 essential considerations when choosing an eClinical platform: 1. Data Quality It’s crucial to learn how a platform ensures data accuracy. Clean data is the foundation of clinical research, and data problems can hinder the path to regulatory approval. Medrio’s EDC, for example, has form rules like edit checks and skip logic to help ensure rapid and precise data entry. Data is then instantly available for review, analysis, and collaboration with Contract Research Organization (CRO) and site partners. Additionally, Medrio DDC, an eSource solution, has shown to reduce transcription errors by 90%. 2. Regulatory Compliance Check how an eClinical service facilitates compliance. In recent years, global clinical trial regulations have undergone tremendous change — and more is on the horizon. Quality solutions should take compliance concerns off researchers’ plates, so they have full peace of mind as they move towards their goals. For Medrio, the software directly integrates global compliance. Additionally, a dedicated team stays on top of upcoming shifts and updates the platform well before any new regulations go into effect. 3. Flexibility and Adaptability Control and independence are also essential considerations. Legacy eClinical services often deliver sophisticated solutions that require external support, which can lead to protracted study builds and time-consuming delays. Consider if this type of solution is necessary since research teams can often manage trials easily and independently. We recently sat down with one of our customer success managers who also worked in clinical operations for 15 years. She shared her personal experiences using Medrio and another large EDC and described how, with Medrio, she was able to build and manage studies without outside programming support. Also, during the research process, unexpected obstacles can arise, and researchers need to adapt quickly to stay on a timeline and budget. Check how a service can support you when the unexpected happens. For Medrio, we provide several APIs that can help organizations quickly expand their eClinical capabilities to integrate external platforms if necessary. 4. Customer Support and Training Evaluate the support team. If any snags come along during research, you want to be sure you’re in good hands. Check if they have industry experience and regulatory knowledge. Can they understand and empathize with your challenges? How responsive is the team, and how intuitive is the software? For Medrio, many customer support managers have industry experience. 91% of support cases submitted to Medrio’s headquarters receive responses in 10 minutes or less — no matter what time or day of the week. Also, robust eLearning ensures that users get up and running in no time. 5. Is It Reliable? Finally, it’s vital to look into the track record of an eClinical service provider. How have other researchers leveraged this software for success? How long has the organization been around? Do they have experience working with similar types of research? Medrio has been around for 15 years and has been used in 4,500+ studies with 600+ customers with a 98% customer satisfaction rating. While many eClinical service providers have been affected by recent acquisitions, we stay independent, in control, and entirely focused on customers’ needs. Success Story: Medical Device Company RefleXion Counts on Medrio to Launch First Studies New technology is only going further integrate with clinical trials. And while adapting to the evolving clinical research landscape may come with growing pains, there is vast potential to improve public health in ways that, until recently, seemed out of reach. Choosing an eClinical platform can be a challenging process. Still, focusing on the right questions and finding best-fit solutions can save vast amounts of resources down the road — and better serve populations in need.

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3 Reasons Why eSource Is a Must for Global Trials

What Is eSource? Source data is the initial data recording, and eSource is any source data that is recorded electronically with the goal of producing the highest quality data— faster.  eSource methodologies and collection methods include Direct Data Capture (DDC), electronic outcomes assessments (ePRO/eCOA), and electronic health or medical record (EHR/EMR). eSource simplifies the data collection process by digitizing source data from the start and eliminating the need for transcription and the risk of transcription errors thereby producing cleaner, more reliable data. Why is eSource a Must for Global Clinical Trials? With the immense growth in the expense and complexity of clinical research over the past decade, outsourcing overseas has become an attractive option to streamline costs, timelines, and patient recruitment. Regulatory harmonization initiatives have helped facilitate multi-regional clinical trials, and many countries now provide incentives to make them more enticing research destinations. Take a look at this: Since the primary reason for outsourcing overseas is to develop life-saving treatments more effectively, it’s vital that new logistical challenges don’t get in the way of that goal. Therefore, as research sites, sponsors, and participants are spread farther across time zones and hemispheres, it’s more important than ever to leverage solutions that facilitate communication, data sharing, and smooth workflows. While solutions to new research challenges brought on by globalization aren’t always simple, eSource goes a long way. For us at Medrio, this means Direct Data Capture (DDC), eConsent, and ePRO; however, this technology takes many shapes, including wearables, electronic health records (EHRs), and other formats. With strong support from regulators, these tools are highly valuable for global clinical trials thanks to their ability to capture high-quality, easily traceable data that can be shared worldwide in real-time. With outsourcing overseas showing no signs of slowing down and many industry leaders signaling that eSource will soon become the primary mode of data collection, investing in this technology is a central way that researchers can protect cost and timeline gains while bringing life-saving treatments to market faster. Here are 3 reasons why eSource in global trials is a must: 1. The Benefits of Better Data Quality and Real-Time Collaboration The demands for higher data quality and the growth of clinical trials in regions with limited infrastructure underscore eSource’s value. Not only does this technology facilitate data capture and real-time sharing, but also it ensures the quality and traceability of that data. For example, Direct Data Capture (DDC) that syncs directly to EDC can reduce transcription errors by 90%, and real-time edit checks help verify that all input is accurate and compliant. Global researchers can see the impact of eSource. We’re excited about the international collaboration with one of our US-based clients working with sites in Yemen to develop a cholera vaccine. Leveraging direct data capture, site staff quickly gather data offline when Internet connectivity is limited and sync it automatically to EDC when a connection is reestablished. US staff can then instantly view and assess that information, allowing teams to work together from opposite sides of the globe more effectively. 2. The Challenges of Paper-based Monitoring Managing paper-based trials presents challenges, even without great distances. A recent study showed that printing costs alone for a trial of 500 participants could run up to $50,000. Add the time, expense, and complexity of paper-based monitoring in global clinical trials — shipping paper overseas, flying monitors across oceans for site visits — and the cost and time commitment can grow exponentially. eSource has the potential to improve efficiency in this area vastly. A customer of ours, Australia-based Linear Clinical Research, conducts global trials for sponsors and CROs in China and other countries. While Initially using paper, they were able to significantly enhance site operations with the help of direct data capture. They reduced paper usage by 95%, monitoring visits by 50%, and gained near-real-time visibility into data for faster decisions. As a result, they were able to scale up the number of studies they conducted. Also Read: ePRO vs Paper Strategies in Clinical Trials 3. The Enhancements to Patient Recruitment and Retention Patient recruitment is widely known as one of the top challenges that clinical researchers face — a key driver of outsourcing overseas is to speed up the recruitment process. It’s also well known that better patient engagement means a more efficient research process. Even if a region has a vast potential patient pool and a cultural openness to trial participation, ensuring participant comprehension and reducing burden are two ways to keep patients enrolled and engaged. Wearables, Electronic Patient-Reported Outcomes (ePRO), and eConsent give patients the flexibility to provide valuable research data with fewer site visits and ensure that they fully understand what a trial entails. This, in turn, gives researchers a leg up and promotes a faster route to regulatory approval. Even as we grow further apart geographically, technology can bring us closer to breakthroughs than ever before. eSource and its many forms mean that data can be shared faster, allowing researchers exciting new opportunities that weren’t possible even a few years ago. Embracing eSource is now a crucial step that organizations must take to make leaps in productivity and quicken the tempo of developing life-saving treatments — and those who act the fastest position themselves for the most significant impact.

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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, 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:

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Avoiding Headaches In Today’s Complex Phase I Landscape

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 trials, in some respects, uniquely stressful. The absence of a safety profile for the drug being tested can make subject recruitment particularly challenging. And any errors or delays in Phase I can set the tone for the rest of the drug development process. But what if the statistics that ease these pressures — the shorter timelines, lower price tags, and high success rates — are changing? A blogger at Bracken Data, a company providing analysis of clinical trial data, recently noted that the size of the average Phase I clinical trial seems to be increasing. Based on searches on ClinicalTrials.gov, the average Phase I enrollment increased 14% between 2013 and 2015, from 50 to 57. More patients could mean more sites, more forms, and more data, adding time and, consequently, expenses to these trials. This could be exacerbated by other trends adding complexity to Phase I, such as higher rates of outsourcing to CROs and study designs that integrate single ascending dose (SAD) and multiple ascending dose (MAD) approaches. If the years ahead bring larger, more complex Phase I clinical trials, what can researchers do to stunt the spikes in timeline and expense that may come as a result? Simple tools for complex data management As drug development becomes more complex and expensive in Phase I and beyond, Electronic Data Capture (EDC) has become almost synonymous with quick study build and data management. And as demand for EDC increases, the industry has been a venue of intense competition, with vendors racing to develop the next big thing. But when it comes to creating efficiencies that keep timelines and costs down, truly elite eClinical software depends on more than the sleekest and savviest new product or feature; just as important is whether the software is actually user-friendly. When evaluating EDC vendors, researchers should analyze not only the capabilities of a given software but the quality of its interface. How feasible it is to minimize timelines in increasingly large and complex Phase I studies depends in large part on the answers to these questions: This is a reality Medrio has kept in mind while developing our software. While we regularly release products, features, and upgrades that create new successes for users, one of the most popular qualities of the software is its basic user-friendliness. Its ease of navigation and intuitive interface has earned Medrio a reputation as an ideal software for efficient study build and data management. This, in fact, sets us apart from some of the biggest names in EDC, who may have all the bells and whistles a researcher could ask for but still generate complaints about inefficient or overly complicated navigation. They may require users to scroll from one visit page to the next in order to access an eCRF instead of displaying all eCRFs in one easily accessible location; they may continue to display variables and forms that previously entered data has rendered irrelevant. Cases like these show that no matter how far-reaching the capabilities of an EDC software may be, users will still struggle if the software lacks efficient, sensible design. Phase I clinical trials are already notoriously time-sensitive. If the analysis from Bracken Data and the current interest in integrating SAD and MAD approaches do indeed foreshadow a trend toward larger Phase I trials with more complex protocols, they will become even more so. Without the efficiencies made possible by an intuitive and user-friendly eClinical software, such a shift could cause timelines and budgets to spiral out of control. References:

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Data Quality in Your eClinical System — What’s at Stake for a CRO?

If you know Medrio — if you’ve interacted with us at industry conferences, perused our site, or spend a good amount of time on this blog — you know that we see something truly noble in clinical research. We often describe contract research organizations (CROs) as contributors to advancements in public health, as the engine driving some of the innovation that can end up saving human lives. We believe this to be true, and we stand by it. But even though the work of a CRO can have major public health significance, these organizations are still, ultimately, service providers. And like any service provider, the immediate goal of delivering satisfaction to their clients — in this case, clinical trial sponsors — is always top of mind. For contract research organizations, sponsor satisfaction arrives through numerous avenues: shorter study timelines, cost efficiency, data integrity, and more. The eClinical providers vying for their business often position themselves around those first two concerns — we include ourselves in this, as Medrio offers the flexibility and ease of use that allows users to reduce timelines and costs — leaving data integrity, implicitly, as almost a given. But data integrity should figure prominently into eClinical vendor selection at CROs. In my 12 years spent working at a Global CRO before joining Medrio, I took care not to make eClinical decisions based on things like study build time without also giving due consideration to things like query detection and ALCOA assurance. Here are a few reasons why. Case Study: Sciformix Finds an eClinical Ally in Medrio 1. It’s More Than Just Business – It’s Regulatory When things like study build delays cause timelines to drag on, CROs face dissatisfied sponsor clients. The significance of this is not to be understated — it can result in the loss of what could otherwise be a long and fruitful business relationship. But when it comes to lapses in data quality, it’s not just sponsors that organizations have to answer to. There are major regulatory implications as well, and dubious data quality can land organizations in court. The nature of the Biotech/ Pharma/ CRO relationship can quickly get complicated: examples abound in which Biotech X runs an R&D program with CRO Y; Biotech X licenses Global Rights to Pharma A, who in turn sub-licenses European rights to Pharma B. And then — only after all this has occurred — the FDA discovers irregularities with the dossier. By this point, the product may already be on the market and benefit patients. Well, that’s tough. Suddenly at least four companies are under the gun and will have to answer to regulatory authorities, shareholders, and patients. Why risk it? 2. Days And Dollars Are On The Line Any kind of hangup in a clinical trial — whether it’s during study build, patient recruitment, or any other area — can translate to timeline delays. This, of course, includes hangups that owe to issues with data quality. Query resolution, site performance investigation, and source data verification take time. And while CROs often charge by time and thus may not be particularly rattled by every slowdown, it’s important, for the sake of winning repeat business, to keep timelines in check. If timeline efficiency isn’t compelling enough, there’s also the cost factor. Time is money in clinical research, after all, and dealing with data quality issues creates additional expenses for CROs. These organizations walk the tightrope between resourcing ahead or behind the business curve. And when resourcing gets tight, who usually suffers? Money talks, and if tough choices have to be made, often it is the ‘smaller’ sponsor who feels it first. The Product Manager is reassigned. Data Management can’t cope with bogus data. Timelines slip, and with deadlines looming, work is rushed and data entry errors occur. Sound familiar? The Movers and Shakers in the industry want to alleviate the resource problem through enabling tools that sharpen the process. Shouldn’t we all? 3. Protect Your Reputation As sponsor-to-CRO outsourcing continues to rise throughout the industry, a lot will ride on what CROs do to stand out from the competition. Will your organization gain a reputation for rapid study timelines, effective patient recruitment campaigns, and high-quality data? This is far preferable to an organization that makes a name for itself as a frequent subject of regulatory audits due to unreliable data quality. Investing in tools and resources that ensure data quality can bolster your ability to attract positive interest from sponsors — and win more business. CROs are correct to evaluate eClinical software vendors largely based on speed, flexibility, and cost-efficiency. Amidst these concerns, however, data integrity is not to be taken for granted.

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70 Clinical Trial Abbreviations and Acronyms (Quick Guide)

When we talk to people who are new to our industry, one of the toughest things for them to wrap their heads around is the clinical trial abbreviations and acronyms we use. Life science professionals use a multitude of clinical trial abbreviations, and we often rattle off a sentence packed with esoteric acronyms that we assume our listeners will be familiar with. Here is a question that came up on a call recently: “Does GDPR contradict the FDA’s stance on remote SDV and CRFs stored in the cloud?” Now, most people could probably tell you who the FDA is, but if you ask a layperson about SDV and CRFs and how they fit into ICH-GCP under GDPR jurisdictions, you might as well be speaking Klingon. To help, we’ve developed a list of clinical trial acronyms that we use frequently in order to make sure new hires are able to decipher the letters we throw around. If you’re new to the industry or just need to lookup an obscure clinical acronym, we hope this helps. Clinical Trials and Medical Terminology ACA: Affordable Care Act ADaM: Analysis Data Model ADR: Adverse Drug Reaction AE: Adverse Event ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate AMC: Academic Medical Center ARO: Academic Research Organization CCEA: Complete, Consistent, Enduring, Available CDASH: Clinical Data Acquisition Standards Harmonization CDISC: The Clinical Data Interchange Standards Consortium CDS: Clinical Data System CMO: Contract Manufacturing Organization COA: Clinical Outcome Assessments CRA: Clinical Research Associate CRC: Clinical Research Coordinator CRF: Case Report Form (less frequently: Change Request Form) CRO: Contract Research Organization CSDD: Center for the Study of Drug Development CSO: Contract Safety Organization CTMS: Clinical Trial Management System CVM: Center for Veterinary Medicine  DDC: Direct Data Capture DM: Data Manager DSMB: Data and Safety Monitoring Board eCOA: Electronic Clinical Outcome Assessments  eCRF: Electronic Case Report Form ePRO: Electronic Patient-Reported Outcome EDC: Electronic Data Capture EHR: Electronic Health Record eICD: Electronic Consent Document EMR: Electronic Medical Record eSource: Electronic Source Data eTMF: Electronic Trial Master File FDA: Food and Drug Administration FIH: First in Human FPI: First Patient In GCP: Good Clinical Practice  GDP: Good Documentation Practices GDPR: General Data Protection Regulation HHS: Department of Health and Human Services HIPAA: The Health Insurance Portability and Accountability Act IC: Informed Consent ICD: Informed Consent Document ICF: Informed Consent Form ICH: International Council for Harmonization IEC: Independent Ethics Committee IIT: Investigator-Initiated Trial IND: Investigational New Drug IRB: Institutional Review Board MD: Doctor of Medicine MDR: Medical Devices Regulation (EMA) NBE: New Biopharmaceutical Entity NCE: New Chemical Entities NDA: New Drug Application NIH: National Institutes of Health OCT: Office of Clinical Trials OHRP: Office for Human Research Protections (Overseen by the Department of Health and Human Services) PCR: Pending Changes Report PDUFA: Prescription Drug User Fee Act PHI: Protected Health Information PII: Personally Identifiable Information Pl: Principal Investigator PRO: Patient-Reported Outcome RTSM: Randomization and Trial Supply Management SAE: Serious Adverse Event SDTM: Study Data Tabulation Model SDV: Source Document Verification SOP: Standard Operating Procedure tSDV: Targeted Source Document Verification TMF: Trial Master File General Software Terms API: Application Program Interface (also: Active Pharmaceutical Ingredient) CSV:Comma-Separated Values EDC: Electronic Data Capture GUI: Graphical User Interface IRT: Interactive Response Technology  IVR: Interactive Voice Response ODM: Operational Data Model SaaS: Software as a Service solutions SAS: Statistical Analysis System SPSS: Statistical Package for the Social Sciences TFS: Team Foundation Server UAT: User Acceptance Testing

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