{"id":81423,"date":"2024-05-24T15:30:55","date_gmt":"2024-05-24T13:30:55","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&p=81423"},"modified":"2025-12-16T11:46:55","modified_gmt":"2025-12-16T10:46:55","slug":"clinical-data-workbenches-a-buyers-guide","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/clinical-data-workbenches-a-buyers-guide\/","title":{"rendered":"Clinical Data Workbenches: A Buyer\u2019s Guide"},"content":{"rendered":"
\nToday, clinical trials depend on increasing \nAn EDC system produces only about 30% of this data. \nThese manual methods increase effort, costs, and \nFaster, automated approaches are needed to speed \nClinical data workbenches provide a single source of truth for all forms \nThey centralize and harmonize the data, and use automation to reduce \nProviding a single, central location for all trial data [Figure 1]<\/strong> improves \nWhile the first workbench appeared on the market years ago, the \nThe technological advances in this latest generation of clinical data \nThis guide offers a broad overview of data workbench technology, \nThe first step in evaluating clinical data workbenches is deciding \nIf the data workbench will be a net new system, your data review and \nThis checklist groups prospective capabilities into the following business requirements: \nSome solutions in this space rely heavily on services-developed \nApproach workbench evaluation with a healthy dose of skepticism \nEnsure that vendors are transparent about the following:<\/p>\n \nSince services teams can add virtually any capability, services-heavy \nAs you\u2019d do when comparing electric and gasoline-powered vehicles, \nGaining approval for a new business system takes work. To increase the \nFocus your business case on big-ticket items for the key decision \nA good business case should include the following five items:<\/p>\n \nClinical data workbenches are gaining the attention of clinical data \nClinical data workbenches offer an alternative to legacy SAS-based \nAs trial designs become more complex and the volume and variety \nIn addition to providing immediate efficiency gains, a workbench
\nvolumes of patient data from more diverse
\nsources than ever before.<\/strong>\n<\/p>\n
\nTo aggregate and clean the 70% of data that streams
\nin from third-party sources, most data management
\nteams use manual methods that involve the EDC,
\nstatistical computing environments, email, and
\nnumerous spreadsheets.\n<\/p>\n
\npotential risk. Taking data offline for cleaning delays
\nits availability for periods that range from a few days
\nto a few months, preventing more agile responses
\nif safety or quality issues arise.\n<\/p>\n
\nthe availability of clean, consistent clinical data.
\nAn emerging category<\/a> of solutions, clinical data
\nworkbenches (also referred to as clinical data platforms,
\nhubs, or data aggregation and management systems),
\naddresses these challenges.\n<\/p>\nWhat are clinical data workbenches?<\/h2>\n
\nof clinical data, making it faster and easier for cross-functional teams to
\nmanage the diverse patient data in today\u2019s clinical trials. Workbenches
\naddress challenges posed by the growing volumes of data from external
\nsources like labs, wearable devices, and ePRO solutions.\n<\/p>\n
\nreliance on manual processes for transformation and cleaning.
\nWorkbenches also enable better use of analytics, ensure data integrity
\nand quality, and improve collaboration among different stakeholder
\ngroups, thus facilitating increased trial agility and speed-to-market.\n<\/p>\n
\naccessibility for adjacent and downstream processes such as safety
\nsurveillance or medical and clinical reviews. It also establishes a unified,
\nharmonized foundation for clinical data to ensure the successful
\napplication of AI and other emerging technologies.\n<\/p>\n
\nfirst-generation systems were never widely adopted. Today, there are
\nnew offerings from a diverse range of providers, including Edetek,
\nMedidata, Oracle, Saama, Signant Health, and ³Ô¹Ï±¬ÁÏ. Each employs
\na different model and approach. Across the category, workbenches
\nserve a wide range of functions, most of which deliver some but not all of
\nthe following: aggregation, review, query management, transformation,
\nstorage, visualization, and artificial intelligence.\n<\/p>\n
<\/p>\n
\nworkbenches deliver a better return on investment than their predecessors.
\nSponsors and CROs report seeing improvements from modern
\nworkbenches, including fewer manual processes, automated change
\ndetection, external patient data verification, and reduced cycle times for
\nquery management and database lock.\n<\/p>\n
\nsummarizing fundamentals for understanding basic system requirements,
\ndeveloping a business case for investment, and selecting the workbench
\nbest suited to your business needs.\n<\/p>\nDetermining what you need from
\na workbench<\/h2>\n
\nwhat your organization needs and how it could benefit most from
\nthis application. The checklist below summarizes the basic business
\nrequirements to consider.\n<\/p>\n
\ncleaning processes should change to leverage its capabilities. Thus,
\nwhen defining requirements, \u201cask for a car, not a faster horse.\u201d Instead
\nof seeking to improve a legacy process, strive for greater advances by
\ninvestigating what\u2019s possible with these new systems. But verify vendor
\nclaims to ensure your \u201cfaster horse\u201d is not a \u201cflying car.\u201d\n<\/p>\nCHECKLIST<\/h4>\n
System Requirements<\/h2>\n
\nData Aggregation, Data Cleaning, Data Transformation, Data Analysis, and System Infrastructure.\n<\/p>\n
\nData Aggregation<\/h3>\n
\n\n
\nYour data workbench should accept trial data from every source used in your trials and require little to no
\neffort on your part. Be sure that it will ingest data at the frequency you need. Productized integrations between the workbench and preferred data providers add extra value because the providers themselves support them.\n<\/li>\n
\nUpon data ingestion, the system should automatically detect issues within the data structure and in the
\ndata file itself. Ask the vendor what types of issues and errors can be automatically identified. Warnings
\nshould be made available to your data management team and vendor.\n<\/li>\n
\nAsk vendors to describe their data mapping strategies. Utilizing a simple data model<\/a> will reduce the
\nnumber of data mappings that are required. Fewer mappings mean that fewer things that can go wrong
\nand delay the start of data cleaning and review.\n<\/li>\n
\nStandardization generally simplifies downstream activities, but the required data transformations come
\nat a cost. Strike a balance between easing downstream activities and making data available quickly for
\ncleaning and review.\n<\/li>\n<\/ul>\n
\nData Cleaning<\/h3>\n
\n\n
\nMost users want to view data in a tabular form (i.e., as listings), and a workbench should produce tabular
\nlayouts quickly and easily. No-code methods are user-friendly and empower data managers, although sometimes
\ncomplexity cannot be avoided. Thus, look for both code and no-code capabilities to create listings.\n<\/li>\n
\nAutomated checks save time and speed up the cleaning process by automatically identifying data discrepancies
\nand raising queries about them each time new data is loaded. Look for code and no-code options for writing the scripts. Automated checks contribute significantly to a workbench\u2019s ROI, so the greater the capability, the better.\n<\/li>\n
\nWorkbenches centralize query management. You should be able to manage and action queries across multiple
\ndata sources. The ability to track existing queries when data is refreshed will prevent users from wasting time updating spreadsheets or re-reviewing data unnecessarily.\n<\/li>\n
\nWhen centralizing query management, you need mechanisms to support communications between systems
\nand companies. Look for the ability to push and pull queries from external systems, including the EDC.
\nExternal data providers should be able to log in to the workbench to view and resolve queries about their data.\n<\/li>\n<\/ul>\n
\nData Transformation<\/h3>\n
\n\n
\nWhile we don\u2019t recommend performing data cleaning on SDTM datasets, the cleaned data must be transformed
\ninto a standardized structure. Consider whether you want to create SDTM or SDTM-like domains within your
\nclinical data workbench.\n<\/li>\n
\nA workbench should be a conduit through which study data flows. Robust scheduling capabilities allow it to
\nbecome part of an integrated process flow, so downstream users can have data exported automatically as often
\nas needed. It should offer both push (for ad hoc and scheduled exports) and pull mechanisms (via an API).\n<\/li>\n<\/ul>\n
\nData Analytics<\/h3>\n
\n\n
\nDashboards provide visibility into the completeness and timeliness of cleaning activities. Their tracking and
\nmetrics enable leaders to actively manage the process, improve cycle times, and deliver better service to
\ndownstream data consumers.\n<\/li>\n
\nVisualizations make it easier to identify anomalies and trends. As with anomaly detection, you may wish
\nto layer visualization capabilities on top of your aggregated and cleaned data. This capability may exist within
\nyour workbench or via data export capabilities that push the combined data to a dedicated visualization system.\n<\/li>\n
\nArtificial Intelligence and Machine Learning capabilities can help identify data anomalies and atypical values at scale. Surfacing anomalous values helps reviewers focus their efforts. Reviewers should be able to drill down from auto-generated lists to the underlying data for further investigation and to initiate queries as needed.\n<\/li>\n
\nOrganizations using AI\/ML for clinical analyses can benefit from the clean, consolidated data produced by data
\nworkbenches. Ensuring that ML models for RBQM are trained against clean data improves the output quality.
\nEnsure your workbench provides granular controls and scheduling capabilities for data exports.\n<\/li>\n
\nYour workbench should provide a comprehensive and up-to-date status of data cleanliness for all data collected at the individual patient level. A patient-centric view allows data managers to prioritize time and resources and lock patients faster for interim analyses, giving medical and safety teams visibility and perspective for better decisions.\n<\/li>\n<\/ul>\n
\nSystem Infrastructure<\/h3>\n
\n\n
\nWhen evaluating scalability, estimate the number of studies you will run over the next five to seven years and how
\nmuch data they will contain. The workbench must be able to handle the highest volume of data expected from your
\nlargest studies, as these are often the most important, and have the most to gain from a workbench application.\n<\/li>\n
\nAny workbench may perform well when demonstrated on a single study that involves small volumes of data, but
\nhow will it hold up in a mega trial? Ask vendors about their performance testing and for references from customers
\nwho\u2019ve used the technology to handle similar volumes of data.\n<\/li>\n
\nWorkbenches sit between data providers and data consumers; therefore, an open, well-documented API is
\nimperative, and productized integrations are highly valuable. Engage your IT team to evaluate how easy or difficult it will be to integrate this workbench with other systems.\n<\/li>\n
\nAre you buying an off-the-shelf product or a services-based solution? Once the workbench has been implemented, will you need ongoing vendor services? If so, why? What level of service will be required for each study? How much training would your teams need to become self-sufficient in configuring the system for each new study?\n<\/li>\n
\nAsk about the Service Level Agreements (SLAs) related to system up-time and help desk responses. If your studies
\nnever sleep, your workbench system and its support team shouldn\u2019t either.\n<\/li>\n
\nHaving aggregated all of your study data in one place, you need to be confident that it is secure. Make sure any
\nprospective workbench vendor passes a rigorous security audit. <\/p>\n\n
\norganizational and personnel perspective?<\/li>\n
\npenetration testing?<\/li>\nMaintain a healthy dose of skepticism
\nwhen evaluating options<\/h2>\n
\ncustomizations to deliver functionality. Customizations can meet
\nhighly specific requirements and provide cutting-edge capabilities,
\nbut they also result in greater fragility. That fragility increases the
\nongoing maintenance costs for new trials and software upgrades.\n<\/p>\n
\nand request external validation and proof of any messaging claims.
\nPlace extra value on referrals and testimonials from current satisfied
\ncustomers, along with the ROI they have achieved.\n<\/p>\n\n
\nofferings can deliver false positives to RFP questions asking:
\n\u201cCan your system do\u2026?\u201d Ask vendors to specify which capabilities
\nare part of the \u201cout-of-the- box\u201d offering and which are achieved
\nthrough customization.\n<\/p>\n
<\/p>\nWhat is the pricing, and what are the
\ncommercial terms?<\/h2>\n
\nevaluate the Total Cost of Ownership (TCO) rather than just upfront
\nlicensing costs. A workbench\u2019s TCO should include licensing,
\nimplementation and training costs, projected system integration
\ncosts, maintenance fees, renewal costs, and all likely service costs
\nover five years.\n<\/p>\nMaking a business case<\/h2>\n
\nlikelihood of approval, articulate existing challenges and their impact,
\nalong with the anticipated value of your proposed solution.\n<\/p>\n
\nmakers: for programming, it\u2019s the time spent to generate listings; for data
\nmanagement, it\u2019s the manual validation checks and query management;
\nand for safety and medical teams, it is the impact of delayed data.\n<\/p>\n\n
\nDefine the specific business problems and pain points the new
\nsystem will address. List the challenges and delays inherent in
\nmanual processes and bring them to life with quantification and
\nanecdotal examples. Show the limitations and impact of the
\nexisting processes.\n<\/li>\n
\nOutline the proposed solution and its key features. Explain how
\nthese features will address the identified problems and deliver
\ntangible benefits to the organization. Describe the system\u2019s core
\ncapabilities and alignment with the organization\u2019s strategic goals.\n<\/li>\n
\nQuantify the expected benefits of the new solution in terms
\nof cost and time savings, productivity improvements, and
\nquality-of-service measures. For example, how quickly can
\nmedical and safety teams access reliable data? Use
\nquantifiable gains, such as fewer hours<\/a> spent on manual
\nvalidation checks, to demonstrate the system\u2019s potential
\nreturn on investment (ROI).\n<\/li>\n
\nDefine the key steps to deploy the system, train users, and
\ndeliver the change management needed for a smooth transition.
\nAt this point, a detailed implementation plan isn\u2019t realistic.
\nFor the business case, define a realistic plan that provides a
\nreasonable estimate of the resources required. Get input from
\nIT on past costs based on the expected effort required.\n<\/li>\n
\nDescribe the ongoing support and maintenance needed for the
\nnew system. Outline the costs associated with ongoing support,
\nupgrades, and security measures. If incremental configuration
\nor service costs are necessary for each new study, ensure
\nthose are captured and included. A realistic sustainability plan
\ncontributes to long-term system viability and a credible business
\ncase for making the investment.\n<\/li>\n<\/ol>\nTake action<\/h2>\n
\nmanagement leaders. They provide an attractive solution to challenges
\nthat have existed for many years and that are only getting worse. If you
\ndon\u2019t already have a workbench, now is the time to start planning for one.\n<\/p>\n
\nmanual aggregation, transformation, and cleaning to help ensure
\nclinical data quality, regulatory compliance, and patient safety. The
\nlatest generation of workbenches is already demonstrating ROI by
\nsaving time, improving efficiency, and enriching collaboration between
\nclinical trial stakeholders.\n<\/p>\nDelivering value today and tomorrow<\/h2>\n
\nof sources for patient data increase, workbenches are emerging
\nwith the data science tools needed to clean, transform, and analyze
\nclinical data faster and with less effort. Study teams gain quicker
\naccess to a stream of clean and consistent data, helping them be
\nagile and make better decisions, contributing to patient safety
\nand trial efficiency.\n<\/p>\n
\nprovides a foundation for adopting new technologies that support
\nadjacent business processes. Today, it is difficult to layer AI\/ML and
\nother emerging technologies on a siloed, manual infrastructure for
\nclinical data. A modern foundation for clinical data readies the
\norganization for future advances in data management and beyond.\n<\/p>\n