Clinical Trial Blog: Research Insights for Success

Medrio and Avance Clinical Reach 150 Clinical Trials Partnership Milestone

July 14, 2020

Medrio, Inc., the leading provider of eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets, and Avance Clinical, the leading Australian CRO for biotechs have reached a milestone of supporting 150 clinical trials together. Medrio and Avance Clinical’s successful partnership began in 2012 on a Phase I study with 103 patients and 14 sites, with Avance Clinical being Medrio’s first partner in Australia. Avance Clinical has utilized Medrio’s electronic data capture (EDC) solution successfully for the past eight years supporting 158 Phase I studies, 6,047 patients, and 236 sites. The HRECs usual review cycle in Australia, which takes only 4 to 8 weeks, coupled with Medrio’s ability to achieve FPI in less than three weeks is a perfect combination for accelerating study starts, a critical component to Phase I trials. “Medrio has always been a wonderful partner to Avance Clinical. In addition to their EDC, we’ve used their ePRO and Direct Capture solutions, and we’re always impressed by not only their speed and flexibility but also their support. We know that if we have a question or need assistance that it will be addressed immediately and resolved quickly. Our partnership continues to flourish through ongoing clinical trials. We also recently had a great conversation with Medrio on their podcast, Trial Talks, about Australia’s unique position in the midst of COVID-19. I look forward to the continued success and growth of our partnership,” said Yvonne Lungerhausen, CEO, Avance Clinical. In July 2020 Medrio will launch Trial Talks, a clinical trials podcast series. Hosted by Medrio thought leaders, Trial Talks season one will focus on industry trends and challenges, unique solutions, and the perseverance of the industry through one of our toughest challenges, COVID-19. Trial Talks season 1, episode 1 “Why Clinical Trials are Thriving in Australia” will focus on how Avance Clinical prepared for the pandemic, what tools they leveraged that allowed trial continuation, and why clinical trials are currently thriving in the region. “I’ve always been data-driven, and reaching the 150 trials milestone speaks volumes about Medrio and Avance’s relationship. Trust is earned, and I’d like to think that we’ve shown that we offer not only sophisticated clinical trial technology but also pride in our work. Our support team is available 24/7 and I am always proud to hear our customers speak so highly of them. At Medrio we always have the patients in mind, and the faster we can get a trial up and running or provide support, the faster the patients in need will have the drugs, therapies, or devices that they need. I enjoyed interviewing Yvonne Lungerhausen (CEO) and Sandrien Louwaars (Director of Business Development Operations) for the first Trial Talks podcast episode. It was fascinating to hear how Australia and New Zealand are operating in the midst of a global pandemic, and it highlights the perseverance of the industry and the Golden Age of pharma,” explained Mike Novotny, CEO, Medrio. About MedrioMedrio is the leading provider of eClinical technology for pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient-reported outcome responses. Study sponsors and Contract Research Organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit https://medrio.com. About Avance ClinicalAustralia’s Avance Clinical has more than 20-years of experience and is now one of Australia’s leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.Other benefits include:1. The Government R&D grant means up to 43.5% rebate on clinical trial spend2. Telehealth pivot during COVID-19 pandemic – speed and continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class Investigators and sites7. Established healthy subject databases and specialized patient populations8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons

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What to Keep in Mind When Your eClinical Provider Gets Acquired

June 17, 2020

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.

How did Medrio Achieve FPI in Seven Days?

June 8, 2020

“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.

Medrio Assisting Hope Biosciences to Combat COVID-19 with New Stem Cell Clinical Trial

May 13, 2020

Medrio, Inc. the leading provider of eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets, has entered into a partnership with Hope Biosciences Stem Cell Research Foundation – a non-profit research organization dedicated to translational research in regenerative medicine. The foundation is sponsoring three clinical trial protocols, all using mesenchymal stem cells to combat COVID-19. Hope Biosciences, a biopharmaceutical company developing adult stem cell-based therapeutics for a variety of indications, was approved by the FDA on April 10, 2020, for the second of three new protocols for COVID-19. Hope Biosciences’ proprietary core technology extracts mesenchymal stem cells from a very small amount of fat tissue and once purified, grows them into therapeutic quantities. Quantities large enough and repeatable enough to defend the body against COVID-19. This protocol will study the use of HB-adMSCs to protect against the virus. This trial will be open to those at high risk for contracting the virus, such as frontline healthcare workers and law enforcement. This Phase II, randomized, double-blinded, placebo-controlled study will determine whether receiving allogeneic stem cells has an effect on hospitalization and symptoms due to COVID-19. As part of our continued partnership with Hope Biosciences, and in an effort to aid in the fight against COVID-19, Medrio is donating the electronic data capture platform for the duration of this clinical trial. “We’ve worked with Medrio on other studies in the past. They are always willing to go the extra mile to help, and their sophisticated EDC system has worked well for us. When time is of the essence, we’re thankful we have Medrio as a partner to allow us to accelerate our study build so that we can get treatments to patients in need faster,” said Donna Chang, President & CEO of Hope Biosciences. Medrio’s products, services, and employees excel at expediting clinical trial study setup with their flexible and easy-to-configure electronic data capture platform. “We are committed to doing all that we can to help safely expedite clinical trials in the race to beat COVID-19. The Medrio team is thankful for the opportunity to partner with Hope Biosciences Stem Cell Research Foundation and be a part of the solution to testing treatment for COVID-19,” explains Fred Martin, Chief Product Officer of Medrio. Medrio’s EDC, services, and people provide one of the fastest solutions on the market to achieve first patient enrolled (FPI). The EDC accelerates study build with an intuitive drag-and-drop interface that also allows for mid-study changes without downtime. The electronic data capture platform allows for flexible data collection, real-time data monitoring, superior data accuracy, and the quickest database lock. “I speak for all of Medrio when I say that we are thankful for the work that Hope Biosciences is doing to find a treatment for COVID-19, and it’s our pleasure to provide our EDC services for this cause. We’re all in this together,” added Fred Martin. About MedrioMedrio is the leading provider of eClinical technology for pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient-reported outcome responses. Study sponsors and Contract Research Organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit https://medrio.com. Interested in helping to fund this study? Please click https://ghcf.kimbia.com/hopebiosciences

Global CRO Leverages Medrio to Accelerate Clinical Trials

May 8, 2020

MMS Holdings – an award-winning, data-focused contract research organization (CRO) – has successfully leveraged the support services provided by Medrio, the leading provider of eClinical technology for small to mid-sized pharmaceutical companies, to execute a clinical trial sponsor agreement. By collaborating to position high-quality CRO services with Medrio’s fast and easy-to-use eClinical products, MMS is actively demonstrating their ability to deliver a fast, flexible, and affordable solution for pharmaceutical sponsors of all sizes. The agreement exemplifies Medrio’s success in providing CROs with not only quality eClinical technology, but also robust support services that help them provide top-tier services to clinical trial sponsors and grow their business. “Medrio does a lot to ease the process of doing business with our clients,” said Mindy Wolf, Senior Project Manager, MMS. “Their clear, straightforward pricing model makes it easy to get quotes and proposals out quickly. In clinical research, any delay translates to money wasted, so any efficiency in getting proposals issued and to decisions faster is helpful.” Jim Bademian, Associate Director, Statistical Programming and Data Management at MMS, noted the value of Medrio’s integrated platform, which includes EDC as well as a suite of tablet applications: “We know that if we can offer a client one system provider to help meet all of their business needs, it will be a win for us, for Medrio, and for the client.” MMS has been a Medrio user for over five years and has leveraged the platform in a multitude of studies. During this time, the company has benefitted significantly from various aspects of Medrio’s functionality, including the ability to: Their team has found particular success using Medrio in short-term studies. “Medrio is a good solution for sponsors who have very tight timelines,” says Bademian. “MMS can get the database up and running in a very short timeframe.” “The success of MMS Holdings in facilitating this new sponsor relationship is a clear-cut example of the value of Medrio’s partnerships with our CRO customers,” noted Steve Geffon, Chief Commercial Officer at Medrio. “We’re thrilled to have supported their efforts and are excited to serve them in their upcoming research.” To learn more about data management with MMS, visit us online. About MMS HoldingsMMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named Most Outstanding Global CRO in the 2019 Biotechnology Awards. For more information, visit http://www.mmsholdings.com or follow MMS on LinkedIn. About MedrioMedrio is the leading provider of eClinical technology for early-phase pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, eSource, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please contact us at our website.

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Patient Diversity and eClinical Vendor Selection

March 27, 2020

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.

eClinical Customer Service

March 11, 2020

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

September 11, 2019

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

July 10, 2019

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?

May 20, 2019

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

May 16, 2019

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:

Dermatology CRO Executes Enterprise Agreement with Medrio

February 12, 2019

Innovaderm Research, Inc., an innovative clinical research organization (CRO) specializing in dermatology, has finalized a deal to extend their use of Medrio, the leading provider of eClinical technology for early-phase pharma, medical device, and diagnostics clinical trials, through 2023. The CRO has been a regular Medrio customer for over nine years, primarily using the software in Phase I, Phase IIA, or Phase IIB pharma studies. With the new agreement, Innovaderm will continue to have access to a host of resources that will better enable them to deliver sponsor satisfaction and grow their business. The agreement signifies Medrio’s status as a preferred electronic data capture (EDC) provider at Innovaderm. “We’ve long experienced consistent satisfaction from study sponsors when using Medrio,” commented Eric Hardy, Director of Data Management and Statistics at Innovaderm. “We recommend working with Medrio to our sponsor clients, particularly in early phase trials, and when given the discretion to choose the EDC for our trials, we favor Medrio.” Innovaderm cited numerous factors in their decision to commit to this significant extension of their relationship with Medrio. These factors include: The high performance of the Medrio system in early phase pharma studies The flexibility and functionality of Medrio EDC Medrio’s ability to offer high-quality products and services at a low total cost of ownership – a key benefit for organizations conducting early phase studies “The success of Innovaderm is a perfect example of why Medrio delivers the most benefit in early phase clinical trials,” said Mike Novotny, founder, and CEO at Medrio. “With this new agreement, we look forward to continuing to serve one of our longest-tenured customers as they help their sponsor clients bring innovative medical products to market.” About Innovaderm Research, Inc.Innovaderm Research is a prominent Contract Research Organization (CRO) specialized in Dermatology and focused on clinical studies of phase I, II, III & IV. Founded in 1999, the company provides a broad range of services including study design, protocol development, site selection, and patient recruitment, regulatory and ethics submissions, clinical trial management, clinical monitoring, data management, biostatistics, medical monitoring, and medical writing. Innovaderm prides itself on managing its activities in accordance to current Good Clinical Practice (GCP) from the International Conference of Harmonization (ICH), and being fully compliant with major international regulations such as the FDA (USA), Health Canada, EMA (Europe). For further information, please visit http://www.innovaderm.ca. About MedrioMedrio is the leading provider of eClinical technology for early-phase pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, eSource, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient-reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit https://medrio.com.

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