By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.
The eSource Solution
Altus Research, a clinical research facility that partners with the community to advance medicine, conducts pharmaceutical clinical trials of all study phases, with a specialization in women’s health studies. After encountering numerous obstacles with paper-based data entry, the staff decided to join the growing number of sites, sponsors, and CROs throughout the industry who in recent years have adopted eSource and drastically reduced their reliance on paper. They became a customer of Medrio in 2017. What followed has been a continuing success story in monitoring, data sharing, resource optimization, and more.
Challenges with Paper
“There’s simply no room to comfortably store all the paper involved. We had to get rid of paper and go electronic.”
--Rossmeri Montalvo, Site Director, Altus Research
Like most clinical research sites, Altus Research had historically entered and stored all of their data on paper. While this process had its inefficiencies that often frustrated the staff, the longstanding industry-wide norm of using paper source at clinical trial sites had made them reluctant to change. “Our staff understand the paper world very well,” says Rossmeri Montalvo, Site Director at Altus Research. “The processes, the procedures - they know how to organize their studies that way.” But as Altus continued to grow and began to take on more studies, they could no longer deny that paper was becoming a burden - their processes began to demand an efficiency that paper simply could not provide.
Many of the challenges they faced centered around their workflow, in which paper source documents created a number of obstacles. During patient visits, for example, numerous staff members often needed to view a patient’s chart at the same time, requiring them to share - as well as physically keep track of - the sheet of paper on which the chart was printed. Monitoring posed other challenges: If monitoring visits occurred at the same time as patient visits, monitors and site staff would need to compete for access to source documents, causing conflict and creating scheduling inconveniences. These inefficiencies could lead to study delays. “We needed to be able to have two people working on a patient’s chart at the same time,” says Gina Pierce, Database Builder at Altus Research.
Beyond these inefficiencies in monitoring and sharing, the storage of the paper itself caused headaches for the staff at the site. Altus, a growing organization, was overseeing 20 ongoing studies across various clinical trial phases simultaneously - handling the total quantity of paper involved in these projects simply wasn’t feasible. “There’s so much paper, and it all has to be stored securely to protect sponsors’ and patients’ confidential information,” says Ms. Montalvo. “We needed entire conference rooms and bookcases and all this physical space for every single study. There’s just no room to comfortably store all the paper required. We had to get rid of paper and go electronic.” Moreover, given the confidentiality of much of the data, Altus had to take great care to maintain the physical security of the storage space. These combined burdens required great effort by the staff and constituted a drain on the organization’s resources.
The problems with paper had reached a breaking point. Altus needed an alternative approach to data entry and monitoring - one that could free up resources, manage their heavy workload, and keep things moving quickly and efficiently.
The eSource solution
“It makes it really easy for us to navigate back to prior visits. This is important.”
--Gina Pierce, Database Builder, Altus Research
Altus began evaluating electronic alternatives that could deliver them the efficiency they demanded. Upon determining that the first system they tried fell short of meeting the needs of the staff, they decided to make the switch to Medrio eSource. After training and implementing it at the site, Altus quickly found the technology to be easy to use and beneficial to their operations. Aside from its intuitive and efficient user interface, there were numerous features that impressed them about eSource:
The staff was able to enter source data into a native mobile tablet app rather than on printed source forms, empowering them to effectively replace cumbersome stacks and folders full of paper with a handful of lightweight tablets. They were also able to accelerate and simplify their monitoring: By allowing staff to access and share data remotely, eSource eliminated the need to transport and compete for physical documents, allowing site staff and monitors to access data simultaneously from different locations. “A big plus about going live with eSource is that multiple people can access patient charts at the same time,” says Ms. Pierce. Monitors could also quickly navigate to their target data in the tablet, rather than flipping through lengthy paper documents to find the data they needed. These benefits have been a major time and cost saver for Altus, and are especially impactful for their high-enrollment studies, which, without eSource, would generate particularly large quantities of paper to store, transport, and monitor.
Ms. Montalvo also mentions subject-based navigation as a feature that impressed her team, citing not only speed and ease of use as its benefits, but also the way it minimizes the risk of error during data entry. “When staff have to go in and out of the subject numbers to collect data, it creates potential for error. Having the ability to stay within the same subject eliminates errors for us.”
“It also makes it really easy for us to navigate back to prior visits without navigating away from the subject,” adds Ms. Pierce. “This is important because if we see something out of the ordinary, such as high blood pressure, we can quickly go back, to see if that’s something the Principal Investigator needs to be assessing.”
“We’re flowing along and able to step up production because we have eSource as a tool for our site staff.”
--Rossmeri Montalvo, Site Director, Altus Research
The streamlined monitoring and reductions in paper usage that Altus has achieved with Medrio eSource have unlocked major efficiencies for their organization, empowering their staff to simplify and accelerate their processes. Altus is enjoying these efficiencies more and more as they continue to grow and take on larger projects. As Ms. Montalvo notes, “We’re flowing along and are able to step up production - even in large studies with as many as 3,000 patients - because we have eSource as a tool for our site staff.” In addition, site staff at Altus have found it much easier to ensure that their data meets the ALCOA standards for clinical data entry - that is, that all data entered is attributable, legible, contemporaneous, original, and accurate.
On a more fundamental level, the reduction of paper at the clinical trial site has not only provided the staff much-needed relief - it has enabled them to make more productive use of their resources as well. Rather than devoting large portions of their limited space to the logistical and administrative burden of storing paper, Altus can actually utilize that space for the work necessary to meet their goals: seeing patients and conducting research to help bring new medical products to market.
The positive reaction to Medrio eSource has extended beyond the staff members entering data at the site. “Sponsors have been very receptive to it, and like working with electronic source,” says Ms. Montalvo. Ms. Pierce agrees, and takes it a step further: “The monitors have been really happy to use electronic source,” she says. “It seems to make monitoring visits more streamlined.”
Altus is a busy organization conducting a wide variety of ongoing studies simultaneously, and some of those studies are still using paper - at least for now. But as Ms. Montalvo says of her organization’s plans for the future: “I would like all of our studies to use electronic source, and we’re moving toward that slowly but surely.”
About Altus Research
Altus Research is an independent, free-standing, state-of-the-art clinical research facility located in Lake Worth, Florida. Working closely with major pharmaceutical corporations, they help research novel and sophisticated medications, procedures, vaccinations, treatment regimens, and devices and, in turn, seek to promote their successful implementation into modern medical practice. Altus Research has a qualified and dedicated research staff. They provide comprehensive administrative management and experienced study coordinators to allow accurate and timely enrollment and completion of clinical trials. Their research staff has been conducting clinical trials since 1996, and are committed to efficiently fulfilling contractual time and budget parameters and implementing protocol, GCP, and ICH compliance in a safe and comfortable environment. For more information, please visit www.altusresearch.com.
Medrio is a leading healthcare technology company providing eClinical solutions including EDC, eSource, and ePRO for clinical research. Founded in 2005, the company's cloud-based software platform and mobile suite of products 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 across drug, device, diagnostic, and animal health trials. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit www.medrio.com.
Enjoy this case study? Get lots more, and learn all about Medrio, by visiting our website.