When Protocol Amendments Meet RTSM – From Headache to High-Performance
November 10, 2022
Protocol amendments are inevitable, but choosing the right RTSM partner can help you navigate study changes with speed and agility.
Medrio Blog
Medrio’s ePRO Accreditation eLearning Takes Silver in Davey Awards
November 10, 2022
Medrio, a global leader in eClinical software and services used in decentralized, hybrid, and traditional clinical trials, is pleased to announce it received a Silver Award at the 2022 Davey Awards for its “Build It Better: ePRO Accreditation Program.”
How to Overcome the Problem of the Early ePRO Oversell
November 8, 2022
With increasing regulatory requirements for the inclusion of patient-reported outcomes in study data, maintaining the status quo in PRO collection can have costly consequences.
4 Proven Participant Education Techniques to Improve Electronic Collection of Informed Consent
September 20, 2022
Participant education is a critical part of informed consent and one that is easy to improve by leveraging established patient education best practices. Medrio CEO Nicole Latimer discusses some of the most successful approaches she has seen in her career:
How Are You Labeling Your IP? Protect Your Clinical Trial with Distinct Treatment Numbers
September 6, 2022
Does your CRO or sponsor have a policy around IP numbering in clinical trials? If not, they could be putting your clinical trial at risk.
Medrio Completes Successful Type 2 System and Organization Controls (SOC) 2 Examination
September 1, 2022
San Francisco, CA (August 19, 2022) — Medrio, a global leader in eClinical software and services used in decentralized, hybrid, and traditional clinical trials, has successfully completed a System and Organization Controls (SOC) 2 Type 2 examination. The independent third-party report attests to the controls at Medrio regarding the security, availability, and confidentiality of its eClinical technology and solutions.
Winning the Race to FPI with Early Randomization and Trial Supply Management
August 25, 2022
Smart IP Packaging Helps Clinical Trials Avoid Supply Chain Hurdles to Study Startup Ian Davison, Ph.D. Neuroscience, Medrio’s In-house RTSM Subject Matter Expert Packaging decisions may seem benign, but they can have a direct impact on whether a clinical trial experiences supply chain issues. The ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. Employing your randomization software for clinical trials vendors’ expertise early prevents these issues from becoming problems and can expose surprising efficiencies. Facing a myriad of deadlines and deliverables, time- and resource-crunched study leaders maintain a delicate balance around how tasks should be prioritized, day-by-day or minute-by-minute, in the race against the clock to FPI (first participant in). Often this means that critical decisions about the core technologies that will enable the study are deferred until just months (or even weeks) before FPI, and why not? Past practice has shown that with the right vendor, the Randomization and Trial Supply Management (RTSM) system can be refined until days before go-live. But this approach is short-sighted. Triaging other decisions and projects over RTSM activities may seem obvious since it enables the study team to prioritize milestones that require a longer-lead time. In fact, often the product is already packaged, labeled, and sitting in the warehouse by the time the RTSM software decision is made. However, when it comes to RTSM software, there are multiple advantages to engaging a vendor up to a year in advance of study start to ensure that the supply chain and clinical operations are operating in tandem. Packaging and labeling decisions made in advance of platform selection may have inadvertently “designed out” critical opportunities to enhance supply management, clinical operations, and participant safety, to say nothing of basic efficiencies. When leveraged early, the right RTSM vendor can answer several critical IP packaging decisions and streamline clinical trial startup. How are the kits packaged and labeled? Some studies will create a participant pack for the participant’s full participation in the study. For example, if the participant is scheduled to complete 10 visits to the site during the trial, the participant pack is produced with enough product for the full 10 visits and, potentially, labeled with the participant’s unique identification number. As each visit occurs, the site takes a kit from that participant’s participant pack. At the surface, this intuitively seems like an efficient and organized way to manage the supply inventory, but consider what happens if that participant withdraws or is removed from the study after two of the 10 visits. Suddenly the site is holding eight wasted kits because they are in a box that is already dedicated to that participant. Similarly, what if – despite best intentions and care – a kit becomes damaged during the study, leaving that participant without a full cycle? In this instance, the easy decision may be to open another box to take a replacement kit, but suddenly 20 kits are tied to one participant because one kit was broken. Consider the financial implications of this waste. If the product cost is $1,000 per participant pack and there are 10 kits in the box, there’s $10,000 sitting in a box, with limited visibility into what has happened to it. How many kits can fit in a box? The question of how many kits can fit in a box is an important metric. Consider this: what if you only fit eight in a box but set the shipment at nine? This means you’ll need to split the kits into two boxes and have all the inefficiencies associated with tracking two shippers and two temperature logs. And be careful – which kits are in with which temperature logger? Experienced RTSM vendors have the foresight to consider these types of scenarios and can work with you to create harmonized kit and shipment designs. This ultimately reduces not only the cost of shipping but the associated environmental and sustainability impacts as well. How many kits can the site store safely? It’s also important to consider not only how many products can fit in a box but the size of the box. Sites and pharmacies nearly always have limitations on the space they can dedicate to kits. For example, you may be able to put one hundred blister packs of paracetamol (acetaminophen) on a shelf. However, if your products are the size of a shoebox, most pharmacies won’t have the space to hold the same inventory of one hundred. The concern around site storage capacity becomes even greater for products that need to be held at an ultra-low temperature or for controlled substances with security concerns, like opioids. With space at a premium, sites need to consider how much space they have in their -80 freezer. Most sites don’t have the capacity to hold one hundred kits in storage. Additionally, many pharmacies have regulations limiting opioid quantities because of the risk of having a controlled substance in a pharmacy, such as theft. How can I make the best use of my limited IP resources? Eventually, kits that have been packaged, labeled, and stored will need to be distributed to study participants. This provides yet another opportunity for sponsors to enhance trial supply management efficiencies by partnering with the right RTSM vendor. Based on the chosen packaging design, an RTSM can be used to build allocation rules and automate the process of distributing kits based on parameters set by the user. For example, the user may choose to manage supply using a reorder-point method, demand drive, or just-in-time strategy. There may be different sources at different stages in the trial (from pharmacy at visit one, then direct-to-participant subsequently). All of these can be supported by the RTSM, ensuring that the correct IP is always available when and where it’s needed and that there are no missed participant visits or other disruptions to study continuity. Realizing the benefits of fully-optimized RTSM While most studies employ some kind of RTSM solution,
Think Paper is the Safe Choice for Your Studies? Think Again.
March 24, 2022
It’s 2022—the world is embracing digitalization on a mass scale, yet 76% of healthcare organizations admit to printing their consent forms on paper. Why does the clinical trials industry continue to think that paper forms are sufficiently safe and equipped to handle their patients’ most sensitive data? The Real Cost of Paper in Your Trials Tracking the true cost of paper in your trials can be a difficult feat. Despite the advancements of clinical trial technology and growing guidance / acceptance from regulators for collecting electronic clinical data, a surprising amount of paper continues to exist (and it’s costing you more than just financially). The money and resources spent on storing and archiving paper documents, along with the cost of printing and mailing CRFs (case report forms), is not only expensive, but also a time suck. When using paper to collect data, you’re creating a margin of error that doesn’t need to exist. The time and money used to correct those errors—such as misread handwritten data and the need for double data entry—are easy to avoid. Not only is paper costing you time and money, it’s costing you patients. Consent forms are notoriously difficult and confusing for patients to navigate. The confusion from consent forms alone causes almost 30% of patients to opt out of clinical trials, costing you and your sponsors money. When a patient withdraws from a study, not only does it cost the sponsor three times as much to recruit a new patient, it also costs them the time to enroll new patients and the time invested in those lost. Paper requires double data entry, tracking of CRFs and queries, in-house data quality assurances, and management of the paper itself. Imagine the time and money saved by digitizing the process. That means fewer site visits, resulting in less time and money spent on travel. Switching to an eClinical solution relieves your data management team of the tedious tasks of managing paper and gives them the time to do their job more efficiently. Making the transition from paper to digital can be intimidating. But when you look at what paper is costing you; time, money, and patients, the solution becomes clear: it’s time to embrace digital. Also Read: ePRO vs Paper Strategies in Clinical Trials The Impact of Replacing Paper Processes Speed When you integrate digital solutions into your trial, you can expect to save time. Using a digital solution, like electronic patient-reported outcomes (ePRO), eliminates the human error of paper diaries and removes the need for manual data validation. Patients are encouraged to enter their data directly into a web-based portal — accessible on their preferred device — in an on or offline setting and have that information automatically provided to their study team. When it’s time to submit their information, a reminder or trigger form alerts the patient to make sure they don’t miss an entry. Sites are then quickly notified of adverse events or missing data, enabling a swifter response and minimizing the possibility of trial delays or data errors. This translates to more accurate, trusted data that sites, sponsors, and CROs can use to proactively manage their trial timelines. Scalability As of 2021, McKinsey still estimated that 70% of clinical trial participants lived more than 2 hours from the nearest trial site.1 Trials that rely heavily on paper-based processes are limiting their long-term scalability because they are reinforcing the geographic barriers that preclude patients from clinical research. Considering that oncology and rare disease trials are the largest growing therapeutic area2 for clinical research, it’s especially important to remove geographic, physical, and financial barriers that these patient populations are especially prone to experiencing. Electronic consent (eConsent), ePRO, telehealth are helping sites replace paper processes to reach wider and more diverse patient populations and scale their studies for success. Standardizing workflows also helps increase consistency across teams and sites so your processes can scale with your needs. Flexibility In some cases, paper is simply unavailable. Certain patient populations — like elderly or lower socioeconomic classes — lack access or skill to maneuver electronic workflows. With flexible eConsent and ePRO solutions, teams can streamline electronic data collection using their connected eClinical suite, but also support offline data entry and paper consent forms with ease. Instead of choosing one strict method of data collection, find a solution with the capacity and flexibility to support both. Enhance Compliance Going digital allows you to protect your patients personal information with encryption and permissions that meet the global compliance regulations. Due to COVID-19, the FDA and European Medicines Agency were pushed to clarify their guidelines surrounding telemedicine, creating a clearer path for sponsors than there previously had been.3 Staying on top of regulatory changes can be a burden, but with a digital solution that continually performs in depth analysis of regulations around the world and ensures that their solutions are compliant, you can trust that your data is compliant. Patients also find comfort in knowing that your digital solutions are consistently updated to comply with regulations and it saves you time and money.4 Reduce and Replace Paper Using the Right eClinical Solutions Despite living in the digital age, there is still a need for paper. But clinical teams should be looking to reduce their paper processes and embrace digital solutions wherever possible. The transition from paper to digital can be overwhelming, but Medrio is here to help. Not only do we have the experience and proven results, we can meet you at the level of digitization that’s right for you. References
Medrio Proudly Joins Association for Clinical Data Management (ACDM)
March 13, 2022
San Francisco, CA, March 13, 2022 – Medrio announced today that they have joined The Association for Clinical Data Management (ACDM). Medrio is excited to become part of ACDM and engage globally with CROs and industry solution providers, share thought leadership with its members, and be part of advancing and implementing solutions in the marketplace. “Medrio is proud to align with an organization that is equally as enthusiastic about improving the drug development process through contemporary Clinical Data Management practices,” says Nicole Latimer, Chief Executive Officer at Medrio. “We hold ourselves to the strictest standards and regulations when it comes to data management, and we look forward to collaborating with fellow data management experts on how to maintain and improve industry standards.” “Connecting like-minded industry experts in data management with a platform and network for continuous learning, knowledge-sharing, and problem-solving is a key driver of ACDM,” comments Ian Pinto, ACDM Chair from AstraZeneca. “We are excited for Medrio to collaborate, constructively engage, and share experiences that support the continuous improvement of Clinical Data Management practices. We believe they will be a great asset to our growing community of thought-leaders.” ### About Medrio At Medrio, we know it takes a global village to achieve a healthier world. Since 2005, we’ve developed a successful ecosystem of visionary people like you who want to change the world – employees, customers, and partners alike. Our flexible eClinical suite consists of EDC, ePRO, eConsent, Direct Data Capture, and RTSM, and provides the most complete and accurate data in a traditional, hybrid, or virtual trial environment. We’ve supported sponsors, CROs, and sites from across the life sciences industry spectrum. With our help, they have secured more than 375 approvals and achieved critical breakthroughs. Our expertise spans all therapeutic areas and phases of clinical trials. We aim to deliver the best customer experience possible because your success is our success. Learn how we do it at www.medrio.com. About ACDM ACDM represents enthusiastic clinical research professionals with a passion to improve the drug development process by offering an environment for continuous learning and application of contemporary Clinical Data Management practices. Serving the data management community for over 30 years, our commitment is to provide explicit settings for our fellow members to network, share experiences & keep up to date with the latest regulations & standards in the area of Data Management. We also take pride in helping our members in their professional development journey. Our mission is to provide opportunities to constructively engage, collaborate and learn from the industry experts in Data Management, to equip members with the necessary skills to excel in their careers, so they can become the data management experts of the future. At the hub of ACDM activities, our website offers a diverse, valuable resource for all levels of professionals managing clinical data.
It’s Time for Healthcare to #BreakTheBias
March 8, 2022
It’s 2022—over one hundred years have passed since the women’s suffrage movement; women make up more than half of the college-educated workforce; and the U.S. has our first female Vice President. But, many of us continue to ask, “Is that enough?” (Hint: the answer is a resounding NO!)
Medrio, Inc. and PHARMASEAL Unite to Offer Streamlined End-to-End Data Collection and Management for Clinical Studies
September 28, 2021
Medrio, Inc., a leading provider of decentralized and eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets and PHARMASEAL International Ltd., a provider of clinical trial management and governance solutions, have partnered to integrate Medrio’s eClinical data collection suite with PHARMASEAL’s trial management platform, Englity®, to offer full visibility into the collection and management of clinical trial data. “Our new partnership with PHARMASEAL gives our customers expanded visibility and insights into their clinical trial data through a unified system. By integrating Medrio’s eClincal suite with Englity®, we eliminate inefficiencies and potential errors caused by duplicate data entry and constant switching between systems. Engility® is not just a clinical trial management system (CTMS), but also provides electronic trial master file (eTMF) capabilities and site payment management, providing our customers a single vendor solution for all of their data collection and management needs,” said Fred Martin, Chief Product Officer of Medrio. PHARMASEAL was founded in 2016 with a vision to create smarter technology and innovative products for the improvement of health. “By joining forces with Medrio, we will simplify clinical trial management for customers with more user-friendly interfaces, reduced data duplication, and improved trial management visibility, along with the adaptability to suit the needs of different clinical trial designs across all phases of clinical research,” said Daljit Cheema, Founder and CEO of PHARMASEAL. The combination of Medrio’s integrated platform of EDC, eConsent, ePRO, eCOA, Direct Data Capture, and RTSM with Engility® will streamline research by enabling collaboration, agile processes, and enhanced study oversight. Additional benefits include transparent interoperability between PHARMASEAL and Medrio’s eClinical solutions, timely data sharing, and scalable workflows that support larger, later-phase studies. “We are thrilled to partner with PHARMASEAL to offer our customers a world-class CTMS and eTMF solution that seamlessly integrates with Medrio’s flexible data collection and management tools. Medrio customers expect innovative, agile, and high-quality solutions. PHARMASEAL meets those expectations while also mirroring our customer-first mindset and shared objective of simplifying trial complexities. At Medrio, we recognize the value of partnership and that together we are stronger. We look forward to continuing to deliver high-quality data and operational excellence to our customers alongside PHARMASEAL,” detailed Mr. Martin. About Medrio Take control of your clinical research and studies with Medrio’s full-service suite of eClinical Data Management solutions. We’ve been innovators in the clinical trial technology space since 2005, evolving alongside our customers to meet the demands of today’s world. Our integrated platform of EDC, DDC, eConsent, RTSM, and ePRO/eCOA are configurable to meet any trial needs—from traditional to hybrid, or fully remote studies. That’s why sponsors, CROs, and clinicians across all therapeutic areas have leveraged our adaptive, unified technology to power clinical trial breakthroughs and secure over 770 regulatory approvals. Our robust suite of tools was designed to offer you full functionality—without complexity—so you can streamline your study builds and focus on what matters most: your patients. While other eClinical vendors make similar claims, few can deliver the same white-glove customer service paired with patient-centric, proven clinical trial technology. Discover the Medrio difference and see what makes us your most strategic and successful partner. Learn more at medrio.com/company/contact-us/ About PHARMASEAL PHARMASEAL was founded in 2016 by a team of industry leaders who share a vision to create smarter technologies and innovative products for the improvement of human health. The company’s Engility® platform simplifies the management and control of clinical trials for biopharmaceutical and medical device companies. Engility® utilises advanced engineering offering enterprise management with rapid deployment, an intuitive user interface and interoperability with other eClinical applications to optimise trial governance and oversight.
How eSource Optimizes The Clinical Site Experience
September 7, 2021
Trial sites are a cornerstone of clinical research but are often overloaded with a myriad of complex, manual, and time-sensitive tasks. How can sites be expected to create a positive patient experience, ensure safety and efficacy, or provide accurate study data to sponsors if their processes are manual or riddled with inefficiencies? Decentralized eSource solutions are helping sites simplify complex workflows, reduce redundancies, and maximize their protocol efficiencies so they can focus on what matters most—their patients. We will explore how equipping clinical sites with the right eSource technology can result in positive outcomes for sponsors and CROs. Say Goodbye to Paper Once and For All In the era of digital health trackers and electronic consent forms, it’s hard to imagine that some companies still rely on paper. But they do — lots and lots of paper. One study found that the average 1500-bed hospital prints over 8 million pages per month, totaling about $3.8 million in resources annually.1 Even worse, 76% of healthcare organizations that use an EHR platform admitted to using paper consent forms.1 When sites rely on paper processes, it can result in major disturbances to your trial, including: Sponsors and CROs should make it a point to completely eradicate paper from their site workflows. eSource solutions unlock the power for paperless data entry and all trial stakeholders will benefit from these decentralized technologies. Sites are free of the burden of storing and keeping track of cumbersome amounts of paper CRFs. Beyond space efficiency, site staff can achieve eClinical efficiency. EDCs that sync directly with your eSuite of Direct Capture, ePRO/eCOA, RTSM, and telehealth integrations give sites the power to manage end-to-end study operations from a single source of truth. No more waiting on manual entry or length validations thanks to a host of automatic edit checks, skip logics, and missing data alerts. Calculated variables offer protection against human error on the part of the user, and protocol changes sent down from the sponsor are easy to implement at the site level. These features offer sites a level of efficiency in their data entry and confidence in their data security that is virtually impossible with paper-based data capture. Also Read: ePRO vs Paper Strategies in Clinical Trials Providing Regulatory Peace of Mind Whenever a game-changing technology arrives in a heavily regulated industry like clinical research, it should come as no surprise when compliance concerns arise. How can sites and other interested parties be sure that a new eClinical tool is aligned with all of the many facets of the regulatory frameworks that govern clinical research? Any eSource user with this concern should find it reassuring that the FDA fully backs eSource, and has released guidance for its use in clinical trials.3 In 2020, as a direct response to COVID-19, the FDA released additional guidance surrounding decentralized eSource technology.4 Medrio’s investments in compliance are particularly strong. Medrio’s eSource applications, like all Medrio products, are fully compliant with HIPAA, 21 CFR Part 11, GDPR, and ICH GCP, and more. Our key compliance features such as SSL encryption, single sign-on (SSO), audit trails, and pre-validated environment are all purpose-built to help you maintain a strong security posture so sponsors, CROs, and your sites can have peace of mind.5 Automate Redundancies and Increase Site Efficiencies eSource was created to alleviate trial burden, not increase it. Yet, due to the growing number of data sources and endpoints collected in a given trial, sites can feel overwhelmed managing what’s expected of them. eSource that funnels through a unified decentralized trial management suite can help sites sift through the noise by automating redundant processes and strategically supporting in-clinic workflows with virtual ones. Patient recruitment and enrollment efforts can be aided by eSource workflows such as telehealth screening visits and electronic consent on a web-based portal. Both solutions remove heavy patient burdens surrounding site-based travel and informed consent while allowing sites to manage the entire process from a single dashboard. Offline and remote data entry capabilities ensure sites can maintain visibility and data quality anytime, anywhere. eSource access can be restricted based on user credentials to protect data security and all data transfers to the sponsor are encrypted. This kind of convenience extends beyond data entry and navigation: eSource also makes it possible for monitors to view data remotely, significantly reducing the necessity of site visits. As such visits typically entail a great deal of preparation on the part of the site, this amounts to a major alleviation of what can be a stressful process. This was put to practice when Swing Therapeutics leveraged Medrio’s eSource for their first hybrid decentralized study. Their sites were feeling uneasy and underprepared to manage partially virtual workflows and achieve patient compliance in a remote setting. With help from a bring-your-own-device (BYOD) ePRO solution model, in tandem with SMS alerts, and an intuitive interface, the site’s concerns were quickly mitigated. Not only did Swing’s sites report that they preferred telehealth visits over in-person visits, but they also commented on the ease of scheduling and convenience of the eSource system. Swing was able to improve their site relationships by using technology that their patients and sites preferred and the study successfully conducted virtual telehealth visits while achieving 97% patient compliance.6 Discover the Medrio eSource Difference It’s difficult to dispute that eSource delivers major time and cost savings to clinical trial sponsors. But the right kind of eSource products can be a source of convenience and comfort for site staff as well. It is this understanding — that the technology can be a boon for all parties involved with the clinical research process — that has earned Medrio a position at the forefront of the eSource revolution.