Acceliant white paper - switching edc platforms to rescue in-flight clinical trials


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Acceliant, a global technology provider of innovative solutions in eClinical trials, today released a white paper entitled "Switching EDC Platforms to Rescue In-flight Clinical Trials." The white paper examines how a robust EDC platform supports lower operating costs for the global life sciences market.

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Acceliant white paper - switching edc platforms to rescue in-flight clinical trials

  1. 1. White Paper Switching EDC Platforms toRescue In-flight Clinical Trials
  2. 2. OverviewThe selection process for utilizing electronic data capture potentially extraneous costs that should be eliminated.(EDC) is thorough, challenging, and time consuming. It is The Acceliant EDC and professional services teams haveconducted with qualified individuals and teams reviewing invested more than one year in researching thesystems that appear to meet various functional underlying issues of EDC failures to help dissatisfiedrequirements and display the necessary performance on customers establish a path to successfully switch from anstability and performance. A pharmaceutical, biotech, EDC platform. The switch can be accomplished withCRO or a medical device manufacturer invests minimal risks, in less time, and with fewer frustrations.considerable time and money in the selection process. This whitepaper delineates Trianz findings and establishesUltimately, a decision is made and a platform is selected. an approach to successful migration from a non-The decision carries with it many implications for the performing EDC platform. Ultimately, the Acceliant teamorganization and its eco-system of partners before and delivered a superior platform and experienced zero post-during the clinical trials. The decision will impact the end migration problems, resulting in a lower total cost of ownership to the client.result data report. An entire eco-system must be trainedand oriented towards a new system, including its Understanding Client Imbroglio and Point of Noprocesses, reporting tools, and various controls in Return to Avoid Dissatisfaction with EDC Platformhandling trials. Each of these aspects involves credibility and Vendorand a time and effort investment by all involved in theclinical trial. No EDC customer should ever be in a position where dissatisfaction levels reach a point of no return.During trials, however, if these systems do not Unfortunately, EDC issues occur more often than not inconsistently meet the requirements of an initial study or the pharmaceutical industry. Before examining the pathare too rigid to meet the changing needs of more complex from a point of no return, let us understand the causallong-term studies, it will leave the EDC client in a difficult factors that contribute to dissatisfaction so that lessonssituation. The client can neither continue the studies can be learned. From these lessons a preventive approachsmoothly nor easily switch to a new platform due to the‘vesting’ in a current platform and the risks involved. can be implemented in the selection process. There are two broad categories of issues that lead to aIn today’s economic environment, companies are point of no return: Dissatisfaction with a platform andcontinuously challenging existing cost paradigms and the service communication or other issues with the softwareexpenses incumbent with manual workarounds. Short- vendor. Both categories have a prolonged interplay thatterm IT solutions to larger EDC problems can incur often leaves customers with no recourse.
  3. 3. In research conducted by the team on this subject, Trianz discerned a number of issues in both these categories. In thefirst category-Dissatisfaction with the EDC Platform-customers cited a dozen reasons for wanting to switch to a newplatform. The most important reasons are cited in Table 1 below.The investment by companies conducting a study Table 1creates a considerable reluctance to change afterthe inception of the study. So, a considerable Top Reasons for Dissatisfaction with an EDC Platformamount of effort is undertaken to resolve issues Buyer’s remorse: Functionality during usage differs from what was demonstrated during the selection processwith the software vendor. In many cases, vendorsrespond and do their best to resolve issues. This Functionality is incomplete and does not meet all requirementsresults in the point of no return situation being Technical performance of system did not meet expectationsaverted through dialogue, a client serviceorientation, and a partnership approach by both Difficulty in usage causing sites to be reluctant in using the systemparties. As far as possible, EDC clients must Data errors and inconsistencies in trialsexhaust this approach in order to avoid Lack of scalability and extensibility to meet new trial needsdeterioration.Unfortunately, we found a significant number of Table 2clients reaching a situation of ‘imbroglio’ when allthe efforts do not yield positive results. The top Top Reasons for Dissatisfaction with an EDC Vendorreasons cited by clients in this category are cited Does not demonstrate the necessary flexibility to address the issues we face- a customer service orientation is lackingin Table 2 on the right. Takes a legal and contractual approach for a financial gainAt this stage, clients are in a situation where Does not think our issues are important enough to be part of the overallnumerous patchworks, internal efforts, manual platform and its normal featuresworkarounds, and other ineffective solutions Was a great partner early on-has now become too big to failbecome the channel for moving trials forward. Allof these approaches, however, incur significant Knows we are stuck due to trials being in-flight and risks of switching.effort, time, and money, ultimately impacting Has no incentive to make the investments necessary to improve the softwarestakeholder satisfaction and financial margins.
  4. 4. Breaking the Imbroglio by Employing the Acceliant Migration FrameworkThe decision to switch EDC vendors after initial deployment in a study is always difficult and risky. Switching to a newEDC tool involves coordination and consensus development with a replacement EDC vendor, the sponsor, sites, datamanagement, regulatory, quality, biometrics, IT, finance, and other stakeholders within the study. In today’s economy,the costs of managing patch-work solutions around a troublesome EDC are enormous.Based on several interviews and live trial- based discussions, the Acceliant team developed a comprehensive frameworkconsisting of four major phases as outlined in the image above. Additional features utilized in Acceliant are the UnifiedTrial Builder, which allows the setup of a CRF within weeks (including iterations and approvals), data-import technologycapable of mapping and importing data across several hundred fields, and scores of forms. Audit capabilities within thesystem, as well as manual validation, provide failure-proof data migration. Migration  Trial specific migration analysis, comprising CRF, Needs and subject, ste, data, reports, and all aspects of the trial life Risks cycle to ensure all needs and risks are mapped out Migration  Mapping planning and dry runs of EDC based on a set up Planning and of the actual CRF. Communication  Logistics planning, training ,and communications to all stakeholders Acceliant  Migration of trial data using Acceliant proprietary Auto-Migrate Auto-Migrate framework comprising automated data migration processes. Execution  Validation and parallel run of trials Acceliant Migration  Trial stabilization and redress of post - Stabilization migration issues. FrameworkCase StudyAcceliant Migration Runs Error Free During a Live Trial for a $6B Pharmaceutical CompanyTaking the Confusion out of the Client EDC ImbroglioDuring the course of an implementation a major contract deficiencies were identified. Multiple rounds ofresearch organization (CRO) chose a reworked EDC discussions with the software vendor did not yield anyoffering that was backed by a large software company. results and the pharmaceutical company ended up in theAfter passing user acceptance testing (UAT) successfully, imbroglio earlier described. On one hand, they could notthe system moved to production and began collecting progress the trial in the existing system with an assurancedata. The initial success of the system gave the CRO that trial requirements would be met. On the other hand,leverage to implement a second EDC trial and successfully switching to a new EDC platform would involve acomplete UAT for that trial as well. As the trial complete evaluation process and risks.progressed, certain non-data issues and system
  5. 5. Acceliant EDC Platform Proven Across Wide Range of Clinical TasksAcceliant is a proven holistic EDC platform in the marketplace. With a 10-year history and more than 300 trialscompleted, Acceliant has been employed successfully across a wide range of clinical trials. Acceliant’s track record ofsuccess is three dimensional. It is one of the few platforms that allows for both paper and EDC form of data capture.Moreover, it has been used for trials ranging from Phase 1 to Phase IV and post market studies. And it has been used fordozens of therapeutic studies as well as device-related trials.Acceliant is a complete Web-based platform and perhaps the most comprehensive built on a single architecture. It ismulti-lingual and rendered on PC, mobile, and tablet computers. Acceliant also comprises a robust ePRO version. Formore details on Acceliant, visit Tablet Web Mobile 3rd Party Site HCP Patient Self System Administrator Notification Administrator 3rd Party User Role Event Groupware Messaging Personalization Management Management Notification IVRS Form Security Data Access CT Admin Session Query Safety Processor Document LMS Import / Export Workflow Reporting Logging / Audit Coding Mgmt ORACLEPlanning the Migration to Acceliant Table 3Migration to the Acceliant EDC platform involved Trial Parameter Statisticscoordination and consensus development with sponsors,sites, data management, regulatory, quality, biometrics, Trial Stage IVIT, finance, and other stakeholders. The planning began No. of Patients 30even before the migration to give key decision makers the No of Visits 15information they needed to make the right move with No. of Sites 20minimal data, minimizing regulatory, and financial risks. A No. of Edit Checks 336comprehensive, fact- based migration plan was developed No. of Data Points for Migration 300by the team which helped business leaders make the rightdecision. Length of the Trial in Years 5
  6. 6.  Trial Specific Fit Analysis. The life cycle of the trial was visualized and the necessary features were clearly documented. It was confirmed that the new EDC platform could be utilized through the life of the study without major impact. Definition of Stability and Success Metrics. A clear understanding of what data migration, stability, and other metrics would be used to indicate EDC rescue and retirement of the old system was established. Communications. The team established a communication plan with the pathways and structures necessary to ensure both end users and members of any affected team would know the progress, impact, and SLA or resolution process. Risk and ROI Analysis. There were two trials under consideration. The risks and ROI involved was clearly defined for both the trials. The decision makers initially decided to move forward with the migration from the existing EDC system to the AcceliantTM Clinical Trial System for both trials. At the conclusion of this particular exercise, one trial showed significant ROI and, because of the long study timeline, indicated a higher risk and thus became a candidate for moving forward with migration. The second trial did not have significant ROI and it was decided to complete the trial with the existing system. Execution Plan. The team developed the milestones encompassing all affected areas and set a realistic timeline for a rescue, providing the resources necessary to implement the rescue on time and on or under budget. The necessary budgets, processes, and timelines were approved and the project commenced.Executing on the Acceliant Migration PlanThe complexity of the EDC, the export of data and work much like the old trial. Trianz professional servicessubsequent import, and the validation process made were able to deploy CRFs within days. Trianz then workedcommunication a cornerstone in the deliverable process. with data management to validate every screen and makeClient leaders , data management, and involved Trianz certain all screens performed as close to the originalprofessionals developed a consistent communication system as possible. As a bonus, the additional features inpathway to ensure that no item was missed, while the the Acceliant EDC system allowed many fields to bedecision making team was involved fluidly to ensure the conditional, only appearing based upon other questions.project was moving forward on budget and within the This improved the original deployment considerably and was added into the deployment.stated timeline. Research associates and projectassistants participated in the process to fostercommunication with system users and to ensure thateveryone knew when a change was coming, and whetherthat change’s impact would be minimal.The Unified Trial Builder was utilized to develop the studyin the Acceliant EDC system. With the flexibility ofAcceliantTM and the powerful features built into theUnified Trial Builder, the new system could be modeled to
  7. 7. Two additional features were added by Table 4moving to Acceliant. The Acceliant EDC Trial Parameters Elapsed Timessystem allowed serious adverse events (SAE)to be tracked more effectively, improving the Development of the Study Database in Acceliant 5 Daysprocess for that portion of the study. The Screen by Screen Validation of the CRF in Acceliant 1 DayAcceliant EDC systems integrated codingmodule allowed events and medications to Test Data Migration on Test Serversbe coded without externalizing the data. In Export of data from current vendorthis phase the training of the CRO data Import of test data 1 Daymanagement professional was conducted by Verification of transferTrianz.. The Trianz staff training allowed the Demonstration of new systemindividuals to collaborate effectively andconsistently meet and often exceed Production Data Migration-Auto Migratedeliverable times as they progressed through Export of data from current vendorcase report form (CRF) pages and data edits. Import of test data 2 DaysA detailed plan for testing and the necessary Verification of transferUAT was refined from the earlier draft and Demonstration of new systemdelivered to the client data managementassociates. Trial UAT in Acceliant 5 Days Go-Live on Acceliant EDC and Retirement of Legacy EDC 4 HoursFor migrating data, the auto-import featureset of the AcceliantTM EDC system became a Total Time for Acceliant Migration 18 Daysnecessity. An export was requested from theprevious EDC vendor and, utilizing the power of the AcceliantTM import tool, the data was mapped to the new sets offorms and fields. Because the data was being migrated as a duplicate, the same field specifications were utilized in theAcceliant System that had been established in the previous EDC system. Of the data points, 316 were unique andrequired manual mapping.UAT Results and Acceliant EDC AcceptanceThe data management group worked with stats and the The clinical and project groups were then utilized to trainTrianz staff to compare data in both the old system and users of the old system and the “go live” date was set.the new system after the export/import process using Communication and teamwork played major roles as allexports of data from both systems. To ensure compliance, communication pathways were utilized to ensure that noit was imperative that every data point be verified in the user was left behind. The timeline and previouslysystem. After a careful review it was determined that the developed plans gave all staff at the CRO and Trianzactual process was 100 percent accurate. professionals the ability to script the implementation phase perfectly. Both studies were migrated in 2011, bothThe system was released for UAT to data management, had zero errors, and both achieved success.followed by the clinical staff, and finally to the sponsor,passing all areas with no major issues. Total time in UATwas less than five working days including three internalreview days and two sponsor review days.
  8. 8. EDC Migration to Acceliant Delivers Trial Assurance and Lower Total Cost of OwnershipThe decision to switch an EDC platform for in-flight trials emphasized teamwork and communications. All of thisis not easy and is fraught with risks. A majority of can be executed in an average of three to six weekscompanies continue to plough forward with higher costs (Including planning time) and at reasonable and well-and operational pains due to a failing EDC platform. In justified costs. This Acceliant Migration was successfullytoday’s economy such costs should be addressed and low- used in migrating trials in critical stages of their life cyclerisk approaches for rescuing trials evaluated. without any errors or risks to the trial. Ultimately, Acceliant delivered trial assurance, legacy EDC retirement,The Acceliant team collaborated closely to develop a lower operating costs, and peace of mind for all teamsmodel that facilitates a trial migration to Acceliant based working towards the success of a clinical trial.on a strong framework that allows for a proper trial-specific feature evaluation, migration, risk assessment,thorough plans, migration, and execution. This frameworkAbout AcceliantAcceliant is a comprehensive clinical trials platform developed by Trianz. It is a multi-lingual platform that provides forpaper and EDC form of data capture for therapeutic as well as device trials from Phase I through IV. With more than 300successful trials, Acceliant has emerged as a tier-1 platform alternative for many clients. For further details on Acceliant,please visit http://www.acceliant.comAbout the AuthorWith nearly 20 years of experience in the biomedical field, Ven Thangaraj, CTO, has been responsible for Acceliant sincethe platform’s inception. He partners with numerous clients in evaluations, deployment, and operations of clinical trialsusing Acceliant. He also consults for top management and data management clients at pharmaceutical, devicemanufacturers, CROs, and biotech companies on clinical trials from lab phase to all further stages of the lifecycle. Venearned a B.S. degree in biomedical engineering from the University of Illinois in Champaign-Urbana, Illinois and a secondB.S. degree in mechanical engineering from Rensselaer Polytechnic Institute in Troy, New York.