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

September 15, 2018

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

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70 Clinical Trial Abbreviations and Acronyms (Quick Guide)

August 3, 2018

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

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3 Early Obstacles in Phase I Clinical Trials, And How to Address Them

April 15, 2018

Anyone with an involvement or interest in clinical research is likely to be aware of the challenges in clinical trials, and in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall by the wayside suffer that fate because of unfavorable efficacy data in the middle and later phases. Many others, though, fall victim to administrative or technical challenges — and these issues often arise not as a compound nears the finish line, but as early as the nascent stages of Phase I. Here are three obstacles that researchers commonly face early in Phase I, as well as some insight into how the right eClinical software can nip some of those obstacles in the bud. 1. Patient Recruitment Across all phases of research, challenges in patient recruitment are often accounted for by a lack of awareness of clinical trials and skepticism of the tested compound’s efficacy compared to existing treatments. Recruitment challenges in Phase I, however, have their own additional causes. Perhaps the most notorious of these is the “guinea pig” fear: as the drug’s safety and tolerability profiles have not yet been established, potential subjects often worry it may pose a danger to their wellbeing. A lack of motivation is another common factor, as most Phase I trials involve healthy volunteers with no medical necessity for the tested compound. The exception to this, of course, is Phase I oncology trials, which enroll sick patients. But even here, patients with an advanced condition and limited time are often reluctant to try a treatment with undetermined efficacy. 2. Site Negotiations Before dosing begins in a clinical trial, there is a period of negotiation dedicated to hammering out details related to administrative matters like site payments. As we discussed in a post last year, the time spent on negotiations with clinical research sites tends to decrease as research moves from one clinical phase to the next. It follows, then, that the negotiation period tends to be the longest in Phase I. In fact, Phase I site negotiations often last more than twice as long as many sponsors prefer. These lengthy negotiation periods threaten to derail timelines even before research has begun. 3. Protocol Uncertainties As Phase I oncology trials enroll sick patients instead of healthy volunteers, eligibility criteria can be strict, and dropout rates are notoriously high. This places the protocols of these trials at particularly high risk of unexpected changes. Indeed, a study by the Tufts Center for the Study of Drug Development found patient recruitment struggles to be a common cause of protocol amendments, with many amendments aiming to change patient eligibility criteria. Outside of oncology, there is another risk: the Tufts study reported that most Phase I protocol amendments take place before patient enrollment begins, and therefore create delays in the nascent stages of a trial that may be difficult to recover from as research progresses. A Software Solution to These Obstacles With these challenges lying in wait, researchers can benefit from entering their Phase I trials equipped with the tools necessary to address them. The right eClinical software can provide both direct and oblique solutions to early Phase I challenges. Medrio’s EDC makes it easy to perform mid-study changes, a feature that eases complications arising from protocol amendments. And the software has a user-friendly drag-and-drop interface that enables researchers to build studies in weeks instead of months, creating time savings that can offset any delays stemming from patient recruitment or site negotiations. The outcomes of Phase I trials set the tone for the rest of the research process. The value of a strong start, then, is difficult to overstate. While these trials face considerable challenges in their early stages, a robust and intuitive EDC like Medrio is available to mitigate those challenges.

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Medrio Announces Accelerated Global Expansion

February 14, 2018

Medrio, Inc. a leading healthcare technology company providing eClinical solutions for clinical trials, announced today the company’s international and domestic channel expansion, which includes EMEA and APAC. On the heels of an exceptional year, Medrio is solidifying the company’s leadership position across pharmaceutical, medical devices, diagnostics, and animal health sponsors and CROs. 2017 was a big year for Medrio, as the company closed a $30 million equity investment from Questa Capital Management, a venture capital firm focused on investing in growth-stage healthcare companies. The investment marked the company’s first infusion of institutional capital in its twelve-year history. “With new and complicated data privacy regulations being issued across the globe, the data stemming from international clinical trials need to be streamlined in a way that meets all the guidelines necessary to take a new product or device to market,” said Mike Novotny, Founder and Chief Executive Officer of Medrio. “As Medrio continues to grow, increasing our international presence is essential to meeting our goals of adding speed, consistency, and security to the data aggregation and analysis process.” To meet increasing demand, including from enterprise-level organizations, both domestically and internationally, the company is opening offices in Charlotte, North Carolina; Heidelberg, Germany; and Tokyo, Japan, and is adding strategic business development headcount, including but not limited to:●    Rob Akers, Vice President of Business Development●    Lewis Baird, Senior Director, Business Development●    Shinya Yamamoto, Ph.D., Managing Director, Asia-Pacific Region These representatives will help take Medrio’s existing international momentum to the next level. This momentum has, in recent months, yielded new partnerships in up-and-coming clinical research destinations such as APAC. Linear Clinical Research, a research company based in Perth, Australia, last year implemented Medrio as their first departure from paper-based data capture. “Our EDC and eSource implementation has created interest within the CRO and sponsor communities,” says Simone Knab, Digital Strategy Lead at Linear Clinical Research. “They understand we’re trying to gain efficiencies, create seamless data flow, and demonstrate to the industry how we can get data results quicker so we can get them to the FDA quicker and drugs can reach the market quicker.” As Medrio leverages the expanded sales team to capitalize on increased demand in the US and overseas, the company will continue to invest in the expansion of its best-in-class eClinical tools. With Medrio’s EDC, eSource, and ePRO products, sponsors and CROs have the fastest, most flexible, and easy-to-use eClinical tools on the market.

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Optimizing the EDC Onboarding Process

January 28, 2018

Let’s say you’ve gone through a rigorous selection process to pick your EDC, deployed it, and are ready to train your staff. Your data management team encompasses a wide spectrum of EDC experience — some data managers have used EDC a lot, others very little — and their training needs, therefore, vary as well. But to your dismay, you discover that only one training option is available: in-person training, beginning with EDC basics, on terms and schedule dictated by the vendor. That’s a problem on several levels. For starters, coordinating schedules and finding a venue for the training can be time-consuming and inconvenient. But the bigger issue is that you’re paying for unnecessary training, delaying start times for studies, and tying up the time of your experienced users to attend sessions they don’t need. Long-time EDC users may find this scenario familiar. But at a time when the EDC industry is making great strides to optimize the user experience, it has become easier than ever to avoid. The push to make EDC more user-friendly extends beyond the software itself to include training and support offerings as well. What does this mean at Medrio? What have we learned about EDC training needs through our interactions with users, and what steps have we taken to put users in control of this essential process? Flexible eLearning for a Shorter Time to Competency We’ve spent lots of time in conversation with lots of EDC users, and found that those conversations often turn to frustrations in the training realm. Users are looking for the flexibility to deliver training by sponsor instead of being confined to an EDC-mandated training regimen. They’re finding that once their costly in-person training sessions finish covering the basics, no time remains to go over the specific needs of their studies. These conversations have thoroughly informed the flexibility with which Medrio has approached training. Users can, for example, opt-out of formal EDC training and integrate training with the Study Initiation Visit. But it’s not enough to offer flexibility through policy — just as important to users is the availability of cutting-edge resources. Observers of the EDC market have noticed that eLearning seems to be on the rise in the industry’s training offerings. With Medrio eLearning, an online on-demand training service, we’ve aimed to address common training frustrations by providing users with general competency in the software, so that any necessary subsequent in-person training can focus on their specific needs instead of going over the basics. And it allows platform users to train at their own convenience, rather than on a schedule dictated by a vendor. Individuals can advance their Medrio knowledge through instructional videos and training modules, and earn their certification. Medrio Customer Support and Services The EDC industry’s increasing focus on maximizing user experience is largely driven by technology and simplicity: the flexibility of the cloud, the rapid data entry made possible with eSource, or the ability to build studies without programming. This also ties into the broader shift from paper-based data collection to electronic methods, as discussed in our blog on ePRO vs Paper Strategies in Clinical Trials.  But on the administrative side, it’s often driven more by the notion that EDC users are entitled to a comprehensive support system that better enables them to conduct their important research with speed and ease. Here are a few things we see as essential rights for EDC users: Until recently, competition in the EDC industry was a matter of racing to convert sponsors and CROs from paper-based data management. Now that electronic processes have become the norm, however, the focus has shifted to making solutions exceptional in terms of user-friendliness. From this perspective, there has never been a better time to be an EDC user.

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