: The ability to aggregate and Visualize Data Efficiently to make impactful Decisions www.eclinicalsol.com White Paper
Table of Contents Maximizing Your EDC Investment... 3 Emerging Trends in Data Collection... 4 Leveraging Emerging Trends for Data Insights... 6 Critical Success Factors in Implementing an Electronic Data Management Strategy... 7 eclinical Solutions elluminate Platform for Aggregation, Standardization, Visualization, and Analytics... 8 Case Study: Expanding US-Based Pharmaceutical Company Implements Proactive, Electronic Data Management Strategy... 10 About eclinical Solutions... 11 References... 11 2
Clinical trial sponsors are facing intense pressures to change the way clinical research is conducted in order to decrease costs and speed up the R&D process. There is also increased scrutiny by regulatory agencies such as the Food and Drug Administration and European Medicines Agency, and compliance with regulations is critical. The ultimate goal is to bring new treatments to market sooner and address unmet patient needs more quickly. An electronic data management strategy can help sponsors achieve this goal. Sponsors need comprehensive solutions to implement this strategy, and technological advances such as cloud computing, analytics, and data repository solutions help facilitate this implementation easily and cost-effectively. maximizing Your EDC investment Most sponsors have adopted electronic data capture (EDC) systems in conducting clinical trials, and these systems are efficient and cost-effective over paper-based systems. However, having an EDC system in place is not enough, and sponsors need to focus on areas that maximize their EDC investment to decrease time and costs in conducting clinical trials. The ultimate goal is to bring new treatments to market sooner and address unmet patient needs more quickly. There are four key areas within an EDC system that sponsors can maximize global library of standard and individual forms Establish a global library of standard forms and components of forms that can be used to set up new trials and studies. Leveraging the EDC to include a library of standard forms, or individual components, enhances efficiency and decreases start-up time for new clinical trials. Dynamic management of lab data No matter how lab data is collected whether through local or central labs, EDC systems can automatically collect all lab data and standardize it into pre-determined parameters. Using an EDC system to manage lab data across clinical trial sites decreases the time needed to clean and consolidate data for analysis; as well as reduces errors that can occur during manual data processing. integrate coding and safety systems EDC systems can integrate with existing coding 3
systems to collect adverse events and medications used during a trial in a standard format. Collecting this data electronically brings efficiencies to the coding process, decreases costly inconsistencies, and enables data comparisons across studies. Targeted source Data Verification For years clinical trial sponsors have interpreted federal government regulations as requiring 100% Source Data Verification (SDV) in clinical trials. Regulators do not expect sponsors to monitor trials at 100% SDV, rather they expect sponsors to monitor trials to the extent needed to ensure data quality. With technology advances provided through the use of EDC systems sponsors have the ability to re-define how monitoring is structured and conducted. No matter how a sponsor decides to handle SDV, whether targeted SDV based on verification of critical trial data, and monitoring through a mixture of on-site visits, central monitoring, adaptive monitoring, and remote monitoring, all require data to be centrally stored and accessible through an EDC system. New approaches to SDV and clinical trial monitoring have the potential to improve safety, data quality, regulatory compliance, and overall trial validity while reducing monitoring costs and time needed to lock the database 1. Emerging Trends in Data Collection Advances in technology continue to evolve how clinical trials are conducted. In particular, technology offers many opportunities to collect clinical trial data in ways that enhance the quality of the data collected, decrease the cost to collect data, and increase the speed and efficiency with which data is collected. The most promising and exciting trends in data collection include real-time data acquisition EDC and clinical trial management systems collect and store data centrally making it available for real-time analysis. The collection of real-time data allows for risk-based monitoring approaches, which the FDA is encouraging. Additionally, real-time data collection empowers centralized trial monitoring, which can provide insights into clinical trial data at an early-stage when sponsors and researchers can act and have a 4
positive impact on study outcomes. Electronic Health records/electronic medical records Patient data is increasingly being captured and stored in EHRs as they are more widely deployed throughout the US and incorporated into the daily workflow of physicians. Forward-thinking sponsors are using EHRs in clinical trials to determine protocol feasibility, accelerate patient recruitment, and conduct retrospective and prospective trials. CDisC share CDISC is moving forward to implement CDISC SHARE (Shared Health And Research Electronic Library), which is a global repository for developing, integrating, and accessing CDISC metadata standards in electronic format. SHARE will help users find, understand, and use rich metadata and controlled terminologies in clinical studies more efficiently and consistently. Additionally, SHARE will improve integration and traceability of clinical data from protocol through analysis 2. Ultimately CDISC SHARE will make it easier to standardize data across the industry and with various partners including sponsors, research institutions and sites, and clinical research organizations. mobile devices to capture vital signs Today mobile health devices capture vital signs including wrist bands, socks, temperature sensors, and biosensing clothing. These devices have the ability to collect and share data, as well as initiate follow up through text and e-mail messages. The opportunities for patient follow up, and to share information with healthcare providers, caregivers, and family members, dramatically exceeds the possibilities offered today. This is a new and quickly growing area. There is strong consumer interest in mobile health devices and consumer interest will drive quick adoption of these technologies. Collecting data from mobile health devices ensures the reliability, quality, integrity, and traceability of the data. Collecting data from mobile health devices introduces additional issues for data integrity and data quality. In September 2013, the FDA released guidance on Electronic Source Data in Clinical Investigations. These recommendations ensure the reliability, quality, integrity, and traceability of data from the electronic source to the electronic regulatory submission that will need to be considered when sponsors select their data collection systems. 5
Today, there is a dramatic increase in the amount of clinical data available to sponsors, and there will be even more data in the future. The challenge, and opportunity, is to leverage data to obtain meaningful insights and act appropriately based on the knowledge gained. leveraging Emerging Trends for Data insights Availability of robust data standard models offer opportunities for sponsors to effectively design their trials with a goal to extract maximum value from trial data. increased emphasis on end-to-end data standardization Standardization allows data to be easily shared with research partners, vendors, and regulatory agencies. Implementing standards and related processes at the onset of clinical trial design and set-up ensures high-quality data is collected in an efficient manner and ensures the data can be easily analyzed for insights downstream. It is critical to implement CDISC foundational standards such as Protocol and CDASH that facilitate planning and data collection phases to expedite innovation and enhance R&D productivity. As more data is collected from various sources, data standardization provides opportunities to compare data across platforms whether it was collected from legacy trials, on-going clinical trials, EHRs, or mobile devices, and obtain actionable insights from the data. an end-to-end data management solution that standardizes, aggregates, and analyzes clinical data from multiple systems and sources. Technology to provide actionable insights Until recently the ability to easily gain insights from clinical data has been a cumbersome and costly process. There are now cost-effective and robust end-to-end data management solutions available to provide insights into your data quickly, easily, and in a format that enhances decision-making. An end-to-end data management solution that standardizes, aggregates, and analyzes clinical 6
data from multiple systems and sources such as EDC, CTMS, legacy studies, clinical research organizations, and partners is ideal. This is becoming essential to achieve significant efficiencies. Additionally, a best-in-class platform will enable information consumers across the organization to interact with data, run ad hoc queries, and access data visualizations to proactively analyze clinical and operational data across multiple trials. A key feature of a best-in-class platform is the use of advanced Extraction, Transformation, and Load (ETL) technologies to enable data mapping and standardization based on CDISC standards. Additionally, platforms that offer scalable warehousing, efficient data computing capabilities, a document management system, and a communication portal between sites and sponsors leverages technology in an integrated manner to efficiently meet complex regulatory requirements. Critical success factors in implementing an Electronic Data management strategy Implementing an electronic data management strategy is a significant initiative that requires considerable effort, time, and planning to be successful. At eclinical Solutions we have worked with a number of clients to develop and implement industry leading technologies and solutions. We have identified three critical success factors that ensure advanced technologies are successful in transforming the clinical trial processes for an organization. identify a cross-functional champion to lead the initiative Critically important to the success of transforming your clinical trial processes is identifying an individual to champion the initiative and unite the various functional groups with a cohesive strategy. The ideal individual should be influential across the organization, have a keen understanding of the different roles each function plays, and understand the various systems and processes. Data Managers have an excellent background to help implement electronic data management strategies. Data Managers also have an excellent understanding of what is necessary to 7
collect, standardize, reconcile, and review clinical trial data and can play a vital role in successfully implementing this strategy. The role of Data Managers can naturally extend into a leadership position that drives the strategy for how data may be used in the future to provide actionable insights. identify and align the organization to the ultimate goal For an electronic data management strategy to successfully transform clinical trial processes over the long-term the organization must align to support the ultimate goal. To do this effectively, organizations must understand at the outset how data is used in the organization currently and the goals for leveraging clinical trial data in the future. Key questions to help uncover this information include What problem(s) do you want to solve? What insights are you looking for? Who are the information consumers in your organization? What are the needs these information consumers have in collecting data and gaining insights from it (e.g. real-time safety analysis, risk based monitoring etc.)? Develop and implement a plan for knowledge transfer and training For new processes and systems to be successful over the long-term on-going training and sharing of best practices is required. A successful plan will demonstrate the benefits of the systems; as well as, train new users on the capabilities of the platform and how to use it effectively. Additionally, identify a Super User to share experiences and best practices, as well as reinforce change management principles on an on-going basis. eclinical solutions elluminate Platform for aggregation, standardization, Visualization, and analytics eclinical Solutions secure cloud-based platform, elluminate TM standardizes, aggregates, and analyzes clinical data from multiple sources such as an EDC, clinical trial management system, legacy studies, clinical research organizations, and partners. elluminate TM uses advanced Extraction, Transformation, and Load (ETL) technologies enabling standardization 8
according to a defined data model based on CDISC standards. elluminate TM offers scalable warehousing and efficient data computing, and leverages standard listings and customizable reports. The elluminate TM platform allows users across your organization to interact with data, run ad hoc queries, and access data visualizations to proactively review clinical and operational data across multiple trials. The platform also prepares information for publications, posters, and clinical study reports. elluminate overview The benefits of elluminate TM are Increased transparency and real-time visibility into clinical trial operations and data Enhanced collaboration between investigators, sponsors, and partners Increased efficiency and speed to conduct trials and prepare submission-ready data sets Enhanced capabilities to support effective risk-based monitoring strategies Establish governance models for data, systems, and standards to ensure compliance with regulatory requirements Decreased frustration and costs in completing trials 9
Case study: Expanding Us-Based Pharmaceutical Company implements Proactive, Electronic Data management strategy Our client, a rapidly expanding, US-based pharmaceutical company, was preparing for an increase in their clinical trial activity in the wake of promising results, development partnerships, and several small company acquisitions. In order to scale their data management support, they identified the need to integrate a consistent electronic data management process into their clinical development operations. To this point, the company had been unsuccessful working with various CROs on a per trial basis. The company was using several of the latest EDC technologies and was satisfied with the data collection, but struggled to leverage the data to for proactive trend analysis. This resulted in each study becoming a separate entry prolonging the clinical trial process due to the lack of reusability, lengthy trial start-up times, and increased operational costs. To avoid the re-work required in a trial-by-trial build process, an important initiative was to identify a partner that possessed the knowledge and expertise to build a global library leveraging a leading EDC platform. The client also wanted to be able to aggregate and standardize all their clinical data from multiple CROs, EDC platforms, and legacy data for cross trial analysis and visualization. our solution We worked with the client to establish specific needs and requirements and developed an action plan to implement an electronic data management strategy. First, we assembled a data management team with expert level knowledge of Medidata Solutions Rave EDC platform. Using this tool, the team designed and developed a study that supports the specific requirements of the client s current clinical trials and maintains data cleanliness throughout the entire process. To ensure that standardization is leveraged across their entire program, the team implemented a global library providing our client with the ability to reuse standard forms in their entirety, as well as individual form components. This allowed the client to remain consistent in building new trials in addition to the flexibility to build customized studies and reduce trial start-up timelines. Expanding beyond typical edit checks, the data management plan also included data trending checks, which warrant a more proactive data management approach. To support the client s request to perform continuous reviews of their clinical data in real time, our team implemented elluminate TM integrated with advanced analytics. Our dedicated project manager worked closely with the client, project team, and all third party partners to ensure all tasks are performed efficiently and effectively. Additionally, our subject-matter experts continue to provide strategic consulting and best practice recommendations for optimizing their implementation while also identifying other opportunities for continuous improvement. 10
about eclinical solutions eclinical Solutions seamlessly orchestrates clinical technology and expertise to accelerate the clinical development process. We provide a spectrum of customized data management services and solutions including EDC, data management, clinical reporting, data standardization, and an innovative clinical data repository platform, elluminate TM. Formed in 2006, the eclinical Solutions team has many years of experience working in the life sciences industry dedicated to clinical data management and programming. Through a consultative approach and the mindset that each individual organization has a unique set of goals and objectives, we partner with our customers to maximize one of their most valuable assets, their clinical data. Our clients have benefited by leveraging technology to reduce their costs and gain valuable insight into their clinical trial data. Please contact Marty Roche, Executive Director, Business Development and Marketing, via e-mail at mroche@eclinicalsol.com, to discuss on how we can support your electronic data management strategy. For more information on eclinical Solutions, please visit www.eclinicalsol.com. References 1. Sourabh, De. Perspectives in Clinical Research, 2011. Jul-Sep; 2(3); 100-104. 2. CDISC SHARE, www.cdisc.org/cdisc-share, website accessed October 15, 2013. 2013 eclinical Solutions. All rights reserved. 11
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