Lumenis™ eSource Ecosystem
What is eSource?+
Our comprehensive Lumenis eSource platform captures clinical source data and documents the moment information is collected or recorded. Real-time data capture provides trial sponsors, investigators, and patients the visibility they need to help improve adherence to protocol execution, reduce trial risk, and improve patient safety and engagement. By capturing clinical data at the point of care, Clinical Ink’s platform helps reduce investigator errors, allows sponsors to optimize monitoring activities, and reduces time to data lock.
How does eSource differ from traditional Electronic Data Capture (EDC)?+
Unlike traditional EDC, Clinical Ink’s next-generation Direct Data Capture (DDC) solution eliminates costly, error-prone, and time-consuming paper source data capture and data transcription. Our Lumenis platform collects data electronically at the point of care, eliminating the time and cost burdens associated with paper-based EDC systems. Data captured at the site using the Lumenis eSource platform is instantly available for review within our web-based portal. Study team members have access not only to the data, but also to the actual source documents from which the data originated, making eSource the only solution to truly facilitate centralized, remote monitoring. Learn more about the differences between our process and a traditional EDC process.
How is Lumenis used in a study?+
Studies using the eSource platform typically follow a multi-step process designed to streamline clinical research from start to submit. During the first step (study build), sponsors work with Clinical Ink to develop electronic forms (eSource) in the Clinical Ink launch design tool. From there, sites interact with the Lumenis module to collect data electronically during the subject visit. Intuitively designed eSource forms running on tablets reflect the clinical workflow and look just like traditional paper sources but incorporate all CRF data fields and edit checks. To further streamline the workflow, some studies will connect with many common supporting technologies (e.g., eICF, IVRS, CTMS, device integrations), using our eSource Connect capabilities for advanced features, including audio file uploads, push-button randomization, and automated SAE notifications. To manage studies, sponsors, CROs, and sites use an interactive web-based portal that enables remote review of source documents and CRF data to issue queries and track metrics. During the final submit step, sponsors can leverage our submit capabilities to distribute real-time clinical data formatted according to their existing specifications, including SDTM data formats.
Do regulators accept Lumenis?+
Lumenis is one of the only available technologies that meets all FDA guidelines for eSource, as outlined in the FDA’s September 2013 final guidance on electronic source (eSource). In this guidance, the FDA clearly states, “this guidance promotes capturing source data in electronic form” and “encourages entering source data during a subject visit” for “real-time access for data review.” Similarly, the EMA has also issued an eSource guidance document consistent with the FDA. Studies using the Clinical Ink platform have been the subject of regulatory agency and ministry of health inspections around the world.
How does Clinical Ink meet privacy standards?+
Clinical Ink has administrative functions that limit access to patient data by geographic location, user role, and form permissions. These same restrictions can be applied to enforce study blinding rules.
How does Clinical Ink help sites become more efficient?+
According to a recent survey of eSource platform site users, more than half of all users reported a significant reduction in data queries and overall workload. More statistics from this study include:
- 70% of all users who reported a drop in queries claim a reduction of > 40%.
- 82% of users who reported a drop in their overall workload said it dropped by > 20%
- 28% of users who reported a drop in their overall workload said it dropped by > 50%
Where is the Case Report Form (CRF)?+
The purpose of a CRF is to populate the clinical database; however, the 2013 FDA eSource guidance encourages entering clinical data directly into the eCRF with no paper transcription step necessary. In these cases, the eSource form (eSource) is also the CRF; there is no separate CRF. The difference is that eSource forms have additional source fields as compared to traditional CRFs. When viewing a source form in our Insight portal, highlighted fields denote to a study team member which fields are the exported or “CRF” fields within a form.
What is the typical study build timeline?+
The study build is comparable to existing EDC study builds and requires typically 10-12 weeks from the final protocol or final specifications. However, eSource forms incorporate substantially more data points than typical CRFs (on average, 65% of the data is CRF data while 35% relates to source fields). Additionally, up to 90% of standard CRF edit checks are built into the eSource forms and fire automatically at the time of a subject visit to ensure optimal data and research quality.
How does Clinical Ink impact monitors?+
Clinical Ink can help optimize monitoring activities. Since source data is available in near real time, through the Clinical Ink Insight portal, monitors can centrally review data and documents, reducing the need to travel, and they can work with sites earlier to ensure proper protocol execution. Because Clinical Ink is capturing the source data and the eCRF data at the same time during the patient visit, data errors are reduced, and the need to verify source data is drastically reduced. Clinical Ink enables monitors to shift their focus away from minimally effective and time-intensive monitoring SDV activities to higher-value activities, such as patient recruitment, protocol compliance, and building relationships with sites.
How does Clinical Ink impact data managers?+
Clinical Ink provides significantly more data than traditional EDC systems to provide data managers with a complete context of clinical data. Data queries are significantly reduced by as much as 75% compared to traditional EDC studies because eSource edit checks fire at the time of the subject visit when data can be corrected more easily. Clinical Ink can automate manual data mapping processes via integrations that connect the eSource clinical database to various ad-hoc reporting tools (e.g., JReview, Spotfire, Comprehend). Using the Clinical Ink Insight portal, data managers are given additional tools to facilitate their clinical data review. Data managers can review study data in a domain-by-domain workflow with built-in filtering options to streamline their review as well as access query management features, all in one place. At any time during a review, study team members have access to view the source form from which a potential questionable data field originated to provide the necessary context that would traditionally only be attained from a site visit.
How does Clinical Ink interact with electronic medical records?+
Like traditional EDC systems, Clinical Ink’s next-generation EDC platform does not directly integrate with or replace a site electronic medical record (EMR). However, with Clinical Ink, sites can download source documents as a PDF document for inclusion in a site EMR. Also, like traditional EDC systems, data originally entered into an EMR (e.g., MedHx, ConMeds) must be transcribed into eSource. Document exports out of an EMR can be uploaded into eSource for remote review.
Can the Clinical Ink platform integrate with other systems?+
Lumenis can integrate with a wide range of clinical trial systems, such as eICF, CTMS, Site Payment, and IWRS. During the initial build phase, the scope of work and necessary APIs are defined between Clinical Ink and the additional vendors to align all necessary workflows. Testing of both Clinical Ink and vendor system integrations happen during the normal study build UAT and are fully verified prior to live study deployment.
How is data exported from Lumenis?+
When the study build begins, mapping specifications are configured between the sponsor and the Clinical Ink data management team. Once defined and tested, export frequencies are established to provide data exports in a timeframe and format requested by the study team. Web services are available to pull data directly from the Clinical Ink platform and are configured at the time of study build.
MOBILE PATIENT ENGAGEMENT
What is patient engagement?+
Patient engagement in clinical research refers to a patient’s understanding, involvement, communication, and satisfaction as an active participant in a clinical study. The purpose of patient engagement in clinical research is to improve retention, compliance, and satisfaction by building mutually beneficial collaborations between patients and investigators via two-way communication. This communication may include patient education, reminders, data sharing, and scheduling assistance.
Why is patient engagement important in clinical research?+
A key challenge in clinical trials today is keeping patients motivated, compliant, and engaged with the clinical trial protocol. However, lengthy trials, complex trial designs, lack of motivation, unexpected risks, adverse events, poor communication of trial outcomes, and excessive travel to investigator sites can act as roadblocks to retaining patients. Participants who fail to comply with clinical trial protocol, drop out of a clinical study, or remain disengaged not only jeopardize the quality and integrity of the data, but also contribute to rising costs and development timelines. As such, sponsors face overwhelming demands to increase the pool of volunteers for enrollment in clinical trials while maintaining effective programs to improve patient engagement. Engaging patients early and often is the way to better study results, shorter timelines, and reduced costs.
Where does the pharmaceutical industry stand in terms of mobile patient engagement technology adoption?+
The pharmaceutical industry has embraced the term “beyond the pill,” which is a strategy designed to create value via a range of value-added services, which are primarily digital. Patient engagement technology is part of the “beyond the pill” value chain that can improve patient outcomes and provide competitive advantages. Most companies working with this new market and new technology have limited buying experience and education about these solutions and the potential impact on clinical trial outcomes.
How can mobile technology improve patient engagement?+
The ubiquity of mobile technologies, specifically smartphones, has increased the popularity of patient-centric mobile applications that allow study teams to engage directly with and collect data from clinical trial participants. The integration of mobile technology in new clinical trial designs and business strategy development holds promise for aligning site and patient needs with faster study execution and reduced costs.
What is the regulatory (FDA/EMA) stance on patient engagement?+
Both the FDA and EMA support increased engagement with patients and consumers via mobile technologies for improved development and safety. The FDA encourages more patient-focused drug development and has recently enacted various initiatives that proactively solicit patient feedback as part of the drug development process. Since the 1990s, the FDA has worked with patient advocates to evaluate drugs or medical devices that were close to approval. In 2012, the Patient-Focused Drug Development (PFDD) program was signed into law to more systematically obtain the patient’s perspective on a disease much earlier in the development process to understand its impact on daily lives, the types of treatment benefits that matter most to patients, and the adequacy of available therapies for the disease. A June 2012 presentation by the FDA’s Theresa Mullin, Ph.D., entitled “Patient-Focused Drug Development” highlights the PFDD initiative to collect patient-reported outcomes (PROs) during drug development to better assess effectiveness and guide drug development. Similarly, the FDA’s Patient Representative Program seeks to incorporate the unique perspectives of patient advocates on serious or life-threatening conditions into the drug development process.