white paper Accelerating the Clinical Development Journey with Improved Data Management How eclinical systems can break the data fragmentation barrier The need to improve data management and analysis, make decisions faster to accelerate trial timelines and gain competitive advantages is driving biopharmaceutical and medical device companies to utilize emerging eclinical solutions. The amount of data generated before, during and after a clinical trial has grown exponentially and is often found in legacy systems and applications that were never designed to work together. A new clinical trials data management model must facilitate decision making by unifying data and making it easier to access, archive and share information and collaborate effectively.
Introduction Planning and managing clinical trials today is a complex and challenging task. It typically involves different people spread around the world. It requires the knowledge of complicated processes and systems and the ability to make timely decisions in the face of constant change. 1 State of the Clinical Trials Industry, CenterWatch, 2009 2 Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity, Cutting Edge Information 3 Getz, Kenneth, et al. Quantifying the Magnitude and Cost of Collecting Extraneous Protocol Data. American Journal of Therapeutics, 2013. 80% of Clinical trials fail to meet milestones delaying the delivery of drugs to market. 1 The amount of data generated before, during and after a clinical trial has exploded due to increased protocol complexity and requirements to collect additional data. 3 Data are often fragmented and found in legacy systems and applications that were never designed to work together. The Tufts Center for the Study of Drug Development (CSDD) has shown that as more procedures are performed and more data are collected, study timelines grow longer, patient recruitment and retention grow more difficult and drug development costs increase. 4 Data fragmentation makes data retrieval difficult, complicates the combination of data from multiple sources and increases the risk of failure. Answering key questions regarding a study is time-consuming and has a negative impact on the bottom line. More and more biopharmaceutical and medical device companies are treating data as a corporate asset. They invest in data including the people, processes, and technologies necessary to manage it the same $600K -$8M Companies lose each day a drug is delayed from the market 2 way they invest in any other corporate asset. In clinical development, these companies are increasing investments in eclinical solutions for data management. To be successful, systems should: Allow access via single sign on Be easy to use Integrate multiple functions and help decrease the number of unnecessary and redundant procedures that generate unused data Enable straightforward capture of results from patients Guide users seamlessly from task to task, thereby accelerating their workflow This white paper explores how data fragmentation affects the clinical trials process, especially for companies conducting trials on a portfolio of products. It examines how eclinical solutions can unify data from multiple sources, help manage clinical and operational tasks, optimize workflows and improve decision making. 4 Ibid. Your journey. Our mission ṭm 2
The Chasm between Data, Systems and Therapies The current approach to clinical trials scientific data management struggles to keep pace with the challenges of faster time to market and the increasing complexity of global studies. Fragmented data sources force users to spend more time searching for and aggregating data to make decisions. Fragmentation of data is exacerbated by: Growing protocol complexity that increases the need for additional data 1 2 Technology solutions that aggravate data fragmentation problems Issue 1 Growing Protocol Complexity Increases the Need for Additional Data Tufts CSDD has shown that the complexity of protocol designs has increased dramatically during the past decade as sponsors look to gather larger amounts of clinical data. 5 Tufts CSDD found that between 2000 and 2010, the number of procedures performed in a trial increased by 48 percent. The average number of volunteer eligibility criteria nearly doubled per protocol, and the average number of case report form pages supporting each protocol tripled. Reasons for the increase in protocol complexity included: A focus on chronic illnesses that require additional data to measure more difficult clinical endpoints A need for more data to differentiate products based on efficacy or safety differences Requests for additional data from regulatory agencies, purchasers and payers to address concerns about drug safety and comparative effectiveness Shift of post-approval studies from observational to robust controlled studies Tufts CSDD has also shown that as more procedures are performed and more data are collected, study timelines lengthen, patient recruitment and retention rates drop and drug development costs rise. 6 5 Getz, Kenneth, et al. Quantifying the Magnitude and Cost of Collecting Extraneous Protocol Data. American Journal of Therapeutics, 2013. 6 Ibid. Your journey. Our mission ṭm 3
Issue 2 Technology Solutions Aggravate Data Fragmentation Technology was supposed to solve problems by creating new opportunities to drive the clinical development process forward. While it has achieved that goal in many areas, increased adoption of multiple technologies has now become part of the problem. For example, site personnel may work in multiple applications and need to input different user IDs and passwords for a single trial. They collect study data on different platforms using different applications and legacy systems that do not easily talk to each other and were never designed to work together. This makes it difficult to access, share and reuse data. Data can be hard to retrieve and challenging to integrate, especially when there is no strategy for data integration and workflow optimization. While standards exist for critical areas for example, those proposed by the Clinical Data Interchange Standards Consortium (CDISC) 7 issues exist with regard to implementing and ensuring that all systems are using the same version of a given standard. Data integrations take time to implement. Technology solutions that promise easy integration via open application programming interfaces (APIs) can create issues with technology compatibility, ease of integration and impacts on workflows. For example, data are often moved manually among Randomization and Trial Supply Management (RTSM), electronic Patient-Reported Outcomes (epro) and Electronic Data Capture (EDC) applications. These integrations require multiple quality controls. In addition, disparate data sources are often tied together on a sponsoror study-specific basis and therefore are rarely reusable. Technologies that are not unified cause trial delays, incur costs, increase the risk of failure, impair decision making and negatively affect time to market. 7 These include but are not limited to the Clinical Data Acquisition Harmonization (CDASH), Operational Data Model (ODM), Study Data Tabulation Mode (SDTM), Analysis Data Model (ADaM), and Biomedical Research Integrated Domain Group (BRIDG) standards. 8 EDC and epro Market Trends and Service Provider Performance, May 2013, ISRreports. According to a 2013 ISRreports 8 study, most pharmaceutical companies and CROs recognize the burden of using multiple data collection and trial technologies. There is a trend toward using more tightly integrated systems that house functionality found in current EDC, epro, CTMS and Interactive Voice Response (IVR) also known as Randomization and Trial Supply Management (RTSM) systems but only 50% of those surveyed had experience with these systems. Your journey. Our mission ṭm 4
Case Study: Streamlining Partnerships with Data Integration One global pharmaceutical company recently implemented eclinical technology that enabled it to move from thirty clinical trial service providers to two CROs. The core of the solution was a unified platform with single sign on across multiple systems, true application convergence and ease of collaboration for the entire study community. The platform included CTMS, EDC and RTSM systems. Interfaces and data extracts were designed to make life simpler and to assure reusability with future partners. In just 18 months, the company has realized the following benefits: improved clinical development, decision making and risk management planning a standardized and simplified clinical trial process streamlined monitoring of quality metrics and partner performance management lower hardware, systems maintenance and overall costs Ultimately, data fragmentation affects the bottom line Many of the problems that result from data fragmentation could be alleviated with additional industry standards, consistent implementation of existing standards, integrated workflows and data sharing among applications that are designed to work together. But most biopharmaceutical and medical device companies are not information technology companies. Managing technology implementations and multiple vendors to deploy and integrate technologies is complicated, time-consuming and costly. Until recently, no single solution covered all aspects of a clinical trial for planning, patient recruitment and retention, study execution, database lock and archiving while addressing integration of data sources and the programs that clinical researchers use to design, track and complete trials. If the solution is the data, why is it also the problem? If the promise of integrating clinical data is so high, why are there so many problems associated with data fragmentation? Managing data is hard. Managing clinical data is a lot of work, largely because data are scattered across clinical sites, and different databases and applications operate independently. Sites participating in multiple studies may use different applications for each study, so it takes multiple passwords to log into different applications, meaning that greater effort is required to download data into spreadsheets. Without data integration, it s difficult to ensure data integrity and gaining insights takes time and effort. Data never stops. The velocity of business continues to increase organizations want more data faster. From a data management perspective, the world has become fraught with diverse data sources, data security needs and regulatory compliance process requirements. It is a challenge to develop a fixed data strategy when site- and patient-specific challenges arise during a trial. Change is hard. The relentless pace of business and technological innovation in clinical development contributes to data ills. Suboptimized data processes, attempts to implement outdated and inappropriate technologies into existing processes (instead of changing processes) and regulatory changes all magnify data issues. But basic human and organizational resistance to change may contribute disproportionately to the problem. By acknowledging that change is constant and that technologies will continue to evolve and can be part of the solution (rather than an afterthought), the wise organization is the one that is able to transform data into insights and facilitate decision making. Your journey. Our mission ṭm 5
An integrated eclinical solution The ideal eclinical system is a solution that provides single sign on access to a hosted suite of integrated applications and data. It includes: 1 2 3 Single sign on access to a common user experience to allow users to secure access to multiple applications, aggregated reporting and analytics and collaboration capabilities. The technologies should be unified to assure efficient workflow and task continuity. The integrated system should guide the user, step by step, through any given task without the need to bounce from one application to another. Multiple, integrated applications for eclinical data and workflow management, including the following: RTSM including drug accountability to enable planning, control and traceability of supplies in a safe and easy manner EDC for effective data collection and management to quickly create summary reports and to increase integrity, consistency and efficiencies Electronic Clinical Outcome Assessment (ecoa), including epro solutions, to simplify and facilitate the use of patient reports, including patient recruiting, symptoms measurements, safety information, medical compliance monitoring, and efficacy and quality-of-life assessments by patients at the clinic or via the web eclinical endpoint capture, including integration with a medical imaging solution Collaborative rapid study build environment for the prototyping of transactions and forms and agile change management during the course of a study. The solution should include a reusable library of prebuilt common transactions to reduce study build time Data-driven monitoring and analytics tools to facilitate the use of data analytics to drive the use of study monitor resources, identify site issues, consolidate industry-standard trial performance metrics transactions and forms, including a reusable library CTMS to enable all aspects of trial management, including study planning and tracking, payments and budget management, visit management, monitoring and reporting A software-as-aservice (SaaS) or platform-as-a-service (PaaS) platform that provides the following: Standards-based integration and data sharing across all applications Complete identity management for single sign on, role-based security and access to all appropriate systems Team collaboration via a suite of collaboration tools for document sharing, scheduling, discussion forums and so on Management dashboards and standardized or easy-to-customize reports Minimal setup and upgrade costs without the need for on-premise IT help to install and maintain the solution Your journey. Our mission ṭm 6
A Successful eclinical Solution in Action Integrating a clinical trial s scientific and operational data can decrease the time users spend searching for data, simplify the complex and accelerate time to market by facilitating and improving decision making. eclinical solutions offer these benefits by integrating multiple data streams and simplifying the entire clinical trials process, from study design and data collection to database lock and reporting. eclinical solutions offer the ability to review historic data on site performance, protocol quality, subject recruitment and drug accountability to inform and improve planning for future studies. An eclinical solution should streamline data integration and accelerate clinical development by: enabling users to work in a unified environment integrating multiple data streams reusing data to facilitate decision making providing easier ways to expedite the planning process and monitor the trial in real time optimizing workflows and collaboration Enabling Users to Work in a Unified Environment Users of applications have come to expect easy-to-use, highly functional online interactions such as Internet search or online banking, and increasingly demonstrate little patience for clunky interfaces and multi-step log ins. The successful eclinical solution provides access via single sign on the same way social media, email and online banking log ins allow a user to access multiple websites and applications. Once logged in, a clinical development professional using an eclinical solution is presented with an intuitive user interface that offers easy access data collection and management tools that eliminate the need for integration between multiple applications. Ideally, the eclinical environment delivers functionality that a user needs, regardless of where one product ends and another begins. Integrating Multiple Data Streams Today s clinical trials require the ability to interpret massive amounts of data to drive more informed decisions. The eclinical solution integrates multiple data streams, moves data between applications seamlessly (including data collected from third-party applications and legacy systems), answers key questions and measures progress through a powerful reporting function. For example, the ability to integrate data between a CTMS, an EDC application and an RTSM system ensures that users have a complete, up-to-date picture of study progress to keep clinical operations personnel and senior management fully informed so they can make fact-based decisions. Your journey. Our mission ṭm 7
Leveraging Data to Facilitate Decision Making As a result of data integration, the eclinical solution derives value from generated data by including a powerful reporting function that makes it easy to determine exactly what needs to be measured, provides real-time reports on study progress and helps answer key questions. Clinical development professionals should also be able to view trending information and receive systematic alerts to identify potential issues proactively. In addition, the reporting function should be easily configured so that users are presented with only information relevant to their role. Standard eclinical metrics captured during the course of a trial can create a consistent, consolidated view of the health and progress of trials and enable users to view study performance data to manage multiple trials and programs simultaneously. For example, they should be able to answer key questions about: Recruitment progress Country and site activation progress Study conduct and risk assessment Data management activities Clinical supply chain health status Study close-out Together, reports and performance metrics should allow for the creation of repeatable workflows that help users deliver information to effectively evaluate study performance, identify areas for further improvement and planning, and design and conduct future trial programs. Such pre-validated and repeatable frameworks can maximize valuable savings in time and money. Using consolidated data to enhance decision making Data-driven decision making can help biopharmaceutical and medical device manufacturers and CROs looking to quantify risk and workload at clinical trial sites. An eclinical solution can make the data-driven process easier. Risk in clinical studies includes issues pertaining to patient safety, data quality and even fraudulent behavior. An eclinical solution can identify and quantify serious adverse events, data queries, and recruitment and withdrawal rates. When grouped into risk categories, these metrics allow users to identify potential site problems. Alternatively, the eclinical solution can be used to create a site-focused risk score to identify sites at high risk of enrollment failure and to determine the best ways to monitor them. Workload is an issue for site monitors who juggle numerous time-intensive tasks, including source data verification (SDV), drug accountability, regulatory documentation reviews and site issue follow-ups. An eclinical solution collects workload-related data to provide teams a holistic view of how to manage monitoring at any given site. For example, any reporting of serious adverse events can trigger a site visit. Finally, showing adequate oversight can make it easier to comply with regulatory requirements. An eclinical solution that tracks data changes and activities performed by the team over the course of the trial can demonstrate to regulatory agencies and stakeholders the decision making throughout the trial. This gives sponsors peace of mind when it comes to regulatory submissions. Your journey. Our mission ṭm 8
Providing an Easier Way to Gain Insights An eclinical solution gives users a comprehensive resource for the entire study community, making it a single point of access for all data, information and applications. As a result, decision making can be improved based on near-real-time status updates regarding: Patients recruited Site on-boarding Drug accountability Source documents verified Serious adverse events reported Patient diaries completed Randomization and site quality Access to study documentation, training and training certification Sharing study progress news and announcements Clinical monitoring needs based on risk assessment and site workloads Accessing integrated data from a unified application makes it easy to review and monitor the trial s progress, take actions and conduct the study efficiently and effectively. Data-driven (or risk-based) monitoring demonstrates how comprehensive data views and analytics derived from aggregated data sets not only yield new insights but also drive behaviors. Risk scores based on a wide range of data values, such as unusually low failure rates or high lag time from patient randomization to entry of data in EDC and other applications, can direct a clinical research associate to sites that pose the greatest risk. The benefits include better data quality, reduction of risk and time and decreased costs. As studies progress, data are constantly analyzed and provide new insights and direction. This allows the eclinical solution to serve much like a navigation system that not only tells a driver that road construction is ahead but how to avoid the construction. Optimizing Workflows and Collaboration Improving workflow is about having the right technology in place and standardizing processes to ensure that every task and engagement is handled in the most efficient and consistent manner without the architecture of the application forcing itself on the users. An eclinical solution provides seamless communication across the enterprise, facilitates collaboration among team members and makes it easy to identify gaps and optimize workflows. eclinical solution users can track progress, view milestones and compare actuals to baseline/ predicted activities to complete actions and hit milestones. Progress, milestones and activities can be monitored within the application, which can increase team member communications and productivity. eclinical solutions with intelligent collaboration tools reduce information overload by providing structure and context that connect users and help researchers navigate vital data. Such collaboration tools streamline the study process and change the way clinical trials are conducted. Your journey. Our mission ṭm 9
Optimizing eclinical Solution Implementations with Experienced Partners Deploying an eclinical solution can involve technological challenges, changes in strategy and a need for organizational and/or behavioral changes. Clinical trials are complicated enough without the addition of a new technology that could require modifying workflows and training users. To effectively deploy and operate an eclinical solution requires access to clinical trial technology and process experts fluent in study design, randomization, trial supply management, clinical data management, clinical outcome assessments (COA) and epro, and local regulatory issues. That expertise should include integration services from existing legacy systems to novel solutions and third-party applications. In addition, experts should be available to support the technology, ideally via a single-pointof-contact help desk for global trials. You can lower the risk in implementing and operating an eclinical solution by working with an experienced clinical trials technology partner to configure, deploy and support the solution. What to look for in an eclinical solution partner In-depth study design and consulting experience Data integration expertise across multiple technologies, user interfaces, and identity management protocols Working knowledge of patient-directed data capture via phone, SMS, web, apps, dedicated diaries and medical devices Deep understanding of the analytics and metrics associated with clinical trials Project management expertise Consulting, guidance and support alignment with business objectives Flexible, customized, easy training curriculum tailored to trial requirements Experience aligning goals with outcomes Therapeutic area and indication expertise Integration with clinical trial management and regulatory information management A reputation for proactive client communication A reputation for flawless execution Global 24/7 help desk with one point of contact for all solutions Your journey. Our mission ṭm 10
Enterprise-Level Benefits of eclinical Technologies eclinical solutions provide the full array of clinical development technologies integrating CTMS, EDC, RTSM, ecoa (including epro), eclinical endpoint capture (including medical imaging), data-driven monitoring, metrics and reports, and collaboration tools. From an enterprise perspective, an eclinical solution simplifies workflow and makes it easy to deploy multiple solutions within a single study or portfolio of trials. With enterprise-level reporting, users can answer key questions regarding the performance of multiple studies, including recruitment progress, country and site activation progress, data management activities and clinical supply chain health status. Enterprises using eclinical solutions are able to identify risk signals and trends that can lead to faster, proactive interventions by study teams at sites where potential problems are identified. Organizations benefit when implementing eclinical solutions by: Minimizing data fragmentation Eliminating manual data and application integrations Reducing resource bottlenecks Improving the trial build process and accelerating first patient in by making it easier to configure and/or customize technologies to implement the study protocol Identifying cost- and time-saving opportunities Increasing team collaboration Accelerating study startup and database lock You can increase the value and utility of generated data by reducing data fragmentation, optimizing workflows and enhancing decision making throughout the entire trial process. An open, integrated eclinical solution Security Access Reporting Collaboration CTMS RTSM Medical Imaging epro EDC Regulatory Information Mgt. Datadriven Monitoring Other Apps Integration Platform data Your journey. Our mission ṭm 11
Summary eclinical solutions integrate data from multiple sources, making it easier to identify useful data; share, manage, analyze, and report those data; and optimize workflows. eclinical solutions solve data fragmentation and decision-making issues, and improve clinical development goals, including efficient collaboration and unified communication. These solutions simplify scientific and operational data management, while accelerating post-trial data analysis. To simplify data collection, review and analysis, and incorporation into company processes, eclinical solutions can simplify data collection, review, analysis and workflows using the following critical features: Single sign on access via one username and password to a hosted platform providing a unified environment that allows access to all features and technologies Multiple applications that allow data integration among CTMS, EDC, RTSM, ecoa, eclinical endpoint capture, study management tools, legacy systems and any new tools that may be developed in the future Implementing an eclinical system can benefit from a professional team that has experience with the entire clinical trials process and understands the needs of your company. An experienced clinical trial partner can train your users, minimize risk and help you identify opportunities for cost and time savings. Clinical trial experts help you make better decisions throughout the entire clinical trial process. Biopharmaceutical and medical device companies are increasingly recognizing data as a strategic asset. Companies that use eclinical solutions decrease data fragmentation, improve decision making, and gain a significant competitive advantage over their peers by simplifying the journey from new molecular entity or medical device to market. For more information, contact PAREXEL Informatics regional business development representatives at: The Americas Dave Sunderhaft Vice President, Business Development dave.sunderhaft@parexel.com +1 216 678 0448 Europe Nathan Waller Senior Director, Business Development nathan.waller@parexel.com +34 91 516 5663 Asia Pacific Toyohito Matsuura Senior Manager, Business Development toyohito.matsuura@parexel.com +81 78 262 4344 Your journey. Our mission ṭm 12
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