Clinical Trial Blog: Research Insights for Success

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How to Strengthen Trial Retention Through Patient Education

April 30, 2021

According to a 2019 CISCRP study, 85% of the general public are willing to participate in clinical trial research. Yet, recruitment continues to plague the industry as one of the most costly and timely parts of conducting a trial. Even worse, once studies are underway, teams still need to worry about patient retention in clinical trials and patient drop-out and adherence. Patient withdrawal or non-adherence can stem from a variety of factors including geographical and financial constraints, fear and anxiety, or feeling a lack of appreciation. Whatever the specific reason, the underlying problem is the same: Patients lack critical information about how to find a trial, what the trial will involve, and how the trial will affect their current well-being. These lapses in information exchanges may result in additional recruitment for your sites or result in too many dropouts that make your trial underpowered. Patient education is helping clinical teams strengthen their recruitment and retention efforts by creating healthy information and data exchanges. Understanding the importance of patient education throughout the entire trial lifecycle helps to examine the unintended consequences of uninformed patients and then look at how education efforts are bridging the gap for clinical trial recruitment and retention. Patient Education’s Impact on Recruitment Patient recruitment continues to plague researchers, with the average trial extending recruitment timelines by up to 71%. And each day a trial is delayed due to recruitment, it can end up costing sponsors between $600,000 – $8 million. But, why does recruitment continue to be so cumbersome for researchers, sites, and patients alike? For decades, clinical trial recruitment largely relied on word-of-mouth or paper-based processes. Also Read: ePRO vs Paper Strategies in Clinical Trials Patients would traditionally hear about available studies from their primary physician, who might have limited details on the specifics of the trial and how it would impact their long-term health. Then they might be asked to travel upwards of 2 hours to the nearest site to begin a screening process they knew very little about. But as the global pandemic forced the clinical research industry to start replacing paper processes and focus on patient-centric technology, it still begs the question—why does recruitment continue to suffer? The answer stems from a few reasons: In short: lack of clinical trial awareness continues to be one of the biggest barriers to patient entry in clinical research. Patient education and awareness are critical in the recruitment stage because eligible patients still aren’t aware of where to find available trials, what they involve, or how to provide informed consent. And studies continue to show us that when patients don’t understand trials, they won’t participate in them. The Damaging Impact of Uninformed Patients on Study Success Beyond recruitment, patient education plays an important role in retention and overall patient satisfaction with a research study. With traditional trial operations, patients face a rising number of burdens for participation. From time commitments, travel obligations, informed consent, and treatment expectations—it’s easy to understand why patients feel motivated to withdraw from a study. A survey comparing the experience of patients who dropped out of a trial vs. those that completed a trial found striking differences in their level of understanding what was expected of them: Educating patients throughout the process can help dispel fears and answer questions that strengthen adherence and compliance. The more clearly a disease or treatment is understood, the more likely it is that your patient will be comfortable with their care and adhere to the necessary treatment. Learning about their condition and available interventions through educational programs equips patients with the knowledge to undertake treatments with confidence—even outside of a traditional medical facility. Experts from The American Journal of Medicine stated that “Patient education significantly improves compliance with medication across a broad range of conditions and disease severities. Conversely, lack of compliance is associated with poor clinical outcomes, increased hospitalizations, lower quality of life, and higher overall health costs.” Yet, on average, healthcare professionals spend as little as six minutes training patients on the use of medication. And each time a patient withdraws from a trial due to non-compliance, it costs a sponsor 3 times as much to recruit a new patient. Incorporating Patient Education Into Your Study Builds The need for patient education is widely recognized in the research community. The increase in chronic illnesses, combined with limited hospital facilities, economic constraints due to U.S. healthcare, and a need for better and safer care at home greatly reinforce the importance of patient education. Now, more than ever, clinical research needs to focus on building patient education into their study builds to boost retention rates and ensure the overall success of a study. Improve Clinical Trial Awareness Patient education can help ensure the people who want to participate in clinical research can source and identify a trial easily. The industry used to rely heavily on physician recommendations, but nearly half of millennials don’t have a regular primary care doctor. To improve awareness and education on clinical trial availability, teams can: Establish Trust Early for Long-Term Patient Retention Patient fear and anxiety during a trial can be easily remedied when trust is established with their healthcare and clinical team. Involve patients early in your development plan and establish modes for healthy two-way communication between patients and their research team. This can be done by engaging with patient networks, hosting focus groups, conducting one-on-one interviews, or working directly with patient advisory boards or advocacy groups. You could even encourage former study participants and volunteer advocacy groups to share their clinical trial experience via social media, patient forums, and word of mouth to dispel myths and encourage new patients to come forward. Establishing two-way communication between clinicians and trial participants is crucial for identifying the questions to ask and the outcomes to assess. It will create a more patient-centric trial workflow that leads to improved satisfaction for both stakeholders. And pre-addressing patient concerns allows clinicians to trust their patients fully understand study participation requirements and have the measures in

How Adaptive Trial-Friendly EDC Benefits Oncology

January 28, 2021

Adaptive clinical trial design in oncology research represents an intersection of two major industry trends. One of these is the current prevalence of cancer clinical trials. Clinical Leader cited a GBI Research report that declared oncology the largest therapeutic area in the pharmaceutical industry pipeline. And the promise of immunotherapy continues to galvanize investigations into new cancer treatments. The other trend is the increasing popularity of adaptive trial designs, which have helped the industry neutralize major inefficiencies in their research — not to mention all the discussion and debate they have sparked among industry bloggers and thought leaders. As oncology research is home to a large share of adaptive trials,1 any challenges to the implementation and execution of adaptive design can have consequences for one of the biggest and most important segments of the clinical research industry. As cancer researchers assess whether they’re equipped to successfully execute an adaptive clinical trial, then, the stakes could hardly be higher. The Impact of Electronic Data Capture (EDC) The ability to manage a modern clinical trial hinges in large part not just on whether a trial uses an Electronic Data Capture (EDC) solution, but on what that particular solution is capable of. Indeed, not every EDC can handle adaptive trial designs smoothly. Some, in fact, pose significant inefficiencies, requiring studies to be taken completely offline while protocol changes are implemented. This creates a major delay that many trials with strict timelines can’t afford. Luckily, that delay is ultimately unnecessary – more modern and savvy eClinical solutions offer features that are much more conducive to adaptive trial design. Those features include: EDC brings the capabilities necessary for adaptive trials to data managers – eSource extends those capabilities all the way to the sites. And with adaptive trials on the rise, the ability to handle them smoothly is an invaluable asset for an eClinical platform. Why This Matters for Oncology Adaptive trial design is on the rise across various segments of the clinical research industry. It’s no surprise, though, that they’re pursued to such a high degree in cancer trials. The nature of oncology research, as well as the state of the field today, offer a number of possible explanations for this trend: Innovations such as immunotherapy have brought new uncertainties to oncology, and researchers can benefit from the ability to modify protocols as they learn. Challenges in patient recruitment and retention are notoriously daunting in cancer trials. If a trial misses the enrollment target set in the protocol or the enrollment total changes due to attrition, the ability to integrate those changes seamlessly into an eClinical system can be an important lifeline. The urgency of cancer patients’ conditions, even in Phase I, make the question of whether the treatments in the trials actually work even more consequential. Traditionally, researchers don’t know if a dose is effective until the end of data collection – adaptive designs allow them to modify dosage sooner, increasing the chances of effectiveness. As the trend toward adaptive trial design continues, it will become more and more important for researchers to ensure they have the tools necessary to reap the benefits. eClinical technology plays a major role in this process. Whether researchers possess the right EDC for the job could be a major factor in whether they can keep up with a challenging and evolving field like oncology or lag behind, struggling with the same challenges that have frustrated the field for years. Discover how Medrio addresses adaptive clinical trials and the complexity of oncology trials today. Success Story: TargetCancer Foundation Successfully Empowers Rare Cancer Patients with Medrio References: 1 Hatfield, Isabella; Allison, Annabel; Flight, Laura; Julious, Steven A.; Dimairo, Munyaradzi; Adaptive designs undertaken in clinical research: a review of registered clinical trials; BioMed Central; 19 March 2016

Medrio Inc Names Nicole Latimer as Chief Executive Officer

August 17, 2020

Medrio Inc., the leading provider of eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets, announced the appointment of Nicole Latimer to Chief Executive Officer. Nicole will be replacing Mike Novotny, former CEO and Founder of Medrio as he has chosen to take a sabbatical after leading Medrio’s growth for 15 years. Mike will, however, remain on the Board of Directors. Effective today, Nicole will be responsible for the continued growth and commitment of Medrio to cure all diseases with clinical trial technology. Prior to joining Medrio, Nicole was CEO of StayWell, where she drove the company’s mission to be the premier provider of lifestyle risk management programs for the entire healthcare ecosystem, leveraging behavioral science as the foundation for improving health outcomes. Nicole has also led key initiatives for the Advisory Board and Deloitte Consulting, focusing on population health management, health system growth strategies, patient and employee education, and SaaS development and delivery. Speaking on behalf of the Board of Directors, Mike Novotny said “We are fortunate to have someone of Nicole Latimer’s caliber and experience to lead Medrio into the future. She brings decades of experience in leadership, services, and devices, and she brings a unique perspective of patient insights at a time when patient advocacy demands attention in clinical trials. I am confident that Nicole will take Medrio to the next level while remaining true to our values.” “I would like to thank Mike Novotny for his leadership, entrepreneurial spirit, and vision for the future of the organization. Since its inception in 2005, Mike has done a tremendous job cultivating a team of creative and talented individuals whose determination is evidenced by the loyalty and success of our customers. I am excited to take the reins of this incredible company and grateful for the Board’s confidence in my leadership. I am particularly fortunate to be surrounded by such a talented team as we take this company into the future,” said Nicole Latimer, CEO, Medrio.

The Future of Informed Consent

August 7, 2020

From eClinical data collection to telehealth to wearables and beyond, the clinical trials industry has seen a mass of technological advances over the past decade. Informed consent is critical to every clinical trial, but often a daunting process from the patient perspective. The Benefits to Patients In a paper-based consenting process, many forms are 15 to 20 pages long. That’s a lot of content to consume in a short period of time. Twenty pages could take close to an hour to process, and if you factor in patient questions and concerns you could easily be looking at a multi-hour process. Studies have found that patients prefer simpler and easier to read Informed Consent Forms that can provide them the necessary information to make a decision regarding participation in the trial.1 While required by regulators, the purpose of informed consent is so that patients are aware of the benefits and possible risks associated with treatment. Consent requires patient understanding, which can be improved by using electronic tools that enable rich media content, including videos. Comprehension requires that the patient be able to understand the information presented and have the time and opportunity to read, evaluate and consider the information presented.2 Researchers have studied the merits of an electronic informed consent process and found that patients prefer this method over paper for a number of reasons. Patients felt the electronic process was less stressful because it gives them a greater sense of control and allows them to proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable.3 Reducing patient burden has proven to increase retention by 70%. When many studies are failing to meet their recruitment goals, retention is critical. eConsent puts the patient in control of their consenting process. Empowering patients to make informed decisions increase patient motivation to remain in the study. In addition to patient empowerment, eConsent also allows for rich multi-media, proven to increase patient comprehension. 3 Regulatory Compliance At Medrio, we offer flexible configuration making the switch from paper to eConsent easy to manage on the backend, while offering benefits to patients on the front end. Our solution enables you to instantly propagate the latest version of compliance documents across all sites. In addition to videos and graphics, Medrio eConsent gives you the option of using FAQ documentation and quizzes to ensure patient understanding. Our eConsent solution is safe and secure and meets or exceeds IRB guidelines for the consent process. From ICH/GCP and 21 CFR to GDPR and HIPAA, we give you the tools to focus on the trial and the peace of mind that your data is compliant. With decentralized clinical trials on the rise, now is the time to re-evaluate your consenting process. References: 1. Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Dresden GM, Levitt MA Acad Emerg Med. 2001 Mar; 8(3):246-52. 2. Readability and Comprehensibility of Informed Consent Forms for Clinical Trials Dr Anvita Pandiya Perspect Clin Res. 2010 Jul-Sep; 1(3): 98–100. 3. The Use of Multimedia in the Informed Consent Process Holly B. Jimison, PhD, Paul P. Sher, MD, Yvonne LeVernois, RN, MS, MPA J Am Med Inform Assoc. 1998 May-Jun; 5(3): 245–256.

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

August 3, 2020

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.

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

July 16, 2020

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:

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.

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