Clinpal EDC
The Clinpal EDC solution provides a modern cloud-based patient centric environment for capturing clinical trial data.
Clinpal EDC
Built from the ground up, Clinpal EDC brings together, within a single modular platform, many of the capabilities often seen across different eClinical products.
Suitable for simple single-site or virtual trials through to mega-trials, Clinpal provides advanced, dynamic configured forms that deliver structured datasets out-of-the-box.
Multivariate edit checking, query task management, coding, randomization and data linking are just a few of the standard features available.
Patient Centricity Delivered
eClinicalHealth set the bar for patient centricity in clinical research with the original Clinpal product released in 2014. Any patient in a Clinpal study can access a personalized dashboard offering them an electronic engagement environment supporting their participation in a clinical trial. Since release, Clinpal has engaged patients in 41 countries across 6 continents. Clinpal patients are informed, involved and active stakeholders fostering better retention and data quality.
Integrated eLearning
Ensuring that stakeholder personnel, including site staff, have achieved the right level of training to support a trial is critical from a regulatory compliance as well as a data quality perspective. Clinpal EDC comes with integrated eLearning as part of Clinpal Educate. Staff logging into the Clinpal platform for the first time are automatically prompted to complete their eLearning modules specific to their role before being providing with their full access to the system. This remote eLearning together with extensive reporting reduces the cost of site monitoring and allows site staff to be brought onto a study in hours.
Advanced eCRF Functionality
The old days of having to complete slow, clunky eCRF forms with limited feedback and loss of data when timed out are gone. Clinpal provides a highly modern interactive web experience with immediate feedback on data consistency and completeness. Forms are dynamically presented based on a user’s role, data entered to date and the validity of the data against automated edit checks. This saves time for site personnel and for data management and monitoring over legacy EDC solutions. Standard data linking provides a means for site staff to link one or more Adverse Events to one or more Concomitant Medications.
21 CFR Part 11 compliant electronic signatures provide a record of the confirmation of the completion of sections of the eCRF. Data locking for monitors or data management is fully configurable with an option to allow the primary investigator to indicate the completion of data with a signed or unsigned soft lock.
Clinpal’s ‘unknown’ value flagging and workflow provide an easy-to-use method for handling missing values by providing sites with a simple method of indicating entries that will not be provided.
eCRF Completion Guides
Clinpal has built in contextual help that can be configured as part of the study implementation. This acts as a direct replacement to the common eCRF completion guides with a convenient contextual avatar-driven guide on what to complete, where and when. This ‘just-in-time’ support method reduces the dependency on site staff having to contact helpdesk or monitoring support.
Site Payment Integration
With its built in workflow capabilities, Clinpal is able to trigger alerts based on pre-defined criteria to payment systems for site re-imbursement. These can be based on a combination of simple and complex rules such as the enrolling of patients, the completion of data to a milestone point or responding to queries. This automated processing further reduces the manual effort in reviewing data for payment issuance.
Randomization
Block stratified randomization support is standard with Clinpal EDC. Driven by data entered such as a patient’s weight, gender, or stratum, patients are automatically assigned a randomization code from securely loaded / blinded version-controlled randomization tables. This is conveniently merged into the data entry process avoiding delays and reducing complexity over operating separate Interactive Web Response (IWR) solutions.
Dictionary Coding
WhoDrug, ICD10 and MedDRA support is included. Clinpal EDC introduces a novel advanced approach to eCRF coding by supporting both verbatim and dictionary code selection methods within the same trial implementation. Non-medically trained personnel are required to enter verbatim terms that are queued for coding whereas personnel with the appropriate, confirmed level of training (based around Clinpal Educate) may utilise the adaptive code search and select dictionary method. Utilizing built-in coding ‘right sized and right skilled’ within Clinpal EDC saves time and costs for situations where a central coding solution is not demanded. When central coding is required, Clinpal provides configurable workflow support to automate the presentation of coding tasks to Coding Specialists.
Structured Data
The delivery of structured data has often been an after-thought for legacy EDC solutions. Clinpal EDC provides structured data suitable for reporting, analytics and submissions. Based on industry standards including CDISC CDASH, ODM & SDTM/AdaM, the Clinpal Repository based on the definition of the study provides tabular clinical trial datasets not simply based on a form, but based on the structure of the data sought for reporting. In addition, data is consolidated from all sources – eCRFs, Questionnaires, Patient Diaries & biometric devices as well as eLearning and eInformed Consent.
The highly-advanced workflow is manifested in the Repository through the presentation of detailed tables documenting the interactions by the users between and within forms. This metric information provides the means to report on all aspects of study performance from the successful completion of pre-screening forms through to the rate of progress of patients and sites on their study activities.
Processes ‘built-in’
Clinpal was built from the ground up to support not just the act of capturing data, but to help support all stakeholders through the lifecycle of a clinical trial. Clinical trial protocols, standard operating procedures and user roles all feed into the design and customization of process workflow ensuring all users involved in the execution of the clinical trial – including the patients – know what to do according to their role, and in what order. This process driven approach – similar to that found in the insurance and banking industries – provides a far greater level of configurable action support that has traditionally been seen in eClinical solutions.
Automating the management of the processes around training, data capture and cleaning as well as reporting reduces the mundane labor intensive tasks that are often cost prohibitive when running mid to large scale studies.
How Clinpal works?
Clinpal is fully configurable meaning it does not depend on software customisation to function. Configuration information is defined and loaded using Clinpal tools that promote re-use and automate the definition of tabular data mapping when generating forms. Configuration extends across all form types (eCRF’s, Pre-screeners, eICF’s, eLearning, Patient Diaries, ePRO Questionnaires, and Site Questionnaires). The Clinpal template approach allows sponsors to prepare a ‘standard set’ of forms that can be selectively subset during the study build process. Clinpal standard workflow is provided and can be adapted to meet specific process or organizational demands. Multiple trial instance support provides the means to fully isolate any configuration allowing testing/UAT to be carried out on the Clinpal system prior to production deployment.
Conclusion
Whether Clinpal EDC is used as a single Clinpal package, or, together with the other Clinpal modules, the combination of integrated forms, messaging and workflow create a rich, easy to use environment that supports all stakeholders through the entire lifecycle of a clinical trial. The ability to use different devices ensures the platform is able to suit different operating modes, especially for patients that expect BYOD (Bring Your Own Device) flexibility. The configurable workflow & task management provide automated protocol derived guidance to each user on the activities due to be performed.
Clinpal EDC is the next generation of electronic data capture designed to not just replace a paper CRF, but to enhance the process of running clinical trials leading to better, faster clinical research.
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