{"id":71374,"date":"2023-06-12T22:54:53","date_gmt":"2023-06-12T20:54:53","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?page_id=71374"},"modified":"2026-08-24T16:05:08","modified_gmt":"2026-08-24T14:05:08","slug":"speeding-the-shift-to-science-based-data-management","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/speeding-the-shift-to-science-based-data-management\/","title":{"rendered":"Syneos Health"},"content":{"rendered":"<p>\nAs clinical trials become larger and more complex, the growing focus on patient convenience has greatly<br \/>\nincreased the volume of decentralized patient data along with the need to reconcile it. Staying ahead of change<br \/>\nrequires close focus on the <a target=\"_blank\" href=\"https:\/\/scdm.org\/wp-content\/uploads\/2022\/04\/SCDM-The-5Vs-of-Clinical-Data-FINAL.pdf\" rel=\"noopener noreferrer\">\u201cfive V\u2019s\u201d of Clinical data<\/a>: volume, velocity, variety, veracity, and value.\n<\/p>\n<p>\nSyneos Health, a leading fully integrated biopharmaceutical solutions organization, has approached these<br \/>\nchallenges by shifting from a traditional data management mindset to one based on data science (<strong>Table 1<\/strong>).\n<\/p>\n<div style=\"background-color:#f5f5f5;padding:25px 15px;text-align:center;margin:10px 0 20px 0\">\n<h4>TABLE 1 \u2013 DRIVERS THAT WILL TRANSFORM CLINICAL DATA MANAGEMENT<br class=\"visible-lg\"><br \/>\nINTO CLINICAL DATA SCIENCE<\/h4>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/06\/How-Syneos-Health.png\" alt=\"\" width=\"974\" height=\"625\" class=\"img-responsive\" \/>\n<\/div>\n<p>\nOver the past five years, Syneos Health has worked on more than 2,700 full-service clinical studies involving<br \/>\nmore than 743,000 trial patients and more than 90,000 clinical site partners. These include some of the largest,<br \/>\nmost complex trials to date, including those that enabled COVID-19 vaccines to be developed in record time.\n<\/p>\n<p>\nWorking closely with Veeva Systems, Syneos Health clinical leaders continue to focus on five key objectives:<\/p>\n<ul>\n<li>Improving internal agility<\/li>\n<li>Managing decentralized patient data more efficiently<\/li>\n<li>Increasing connection between clinical operations and clinical data<\/li>\n<li>Improving the user experience for internal and external stakeholders<\/li>\n<li>Taking a risk-based approach to clinical data management<\/li>\n<\/ul>\n<h2>A new role for clinical data management teams<\/h2>\n<p>\n\u201cAs innovation continues to shape clinical trials, clinical data management is emerging from its traditional<br \/>\nindustry role as a supportive back-office function to become integral to innovative product and service delivery,\u201d<br \/>\nsays Nick Lakin, senior managing director at Syneos Health. New approaches to clinical data and use of a<br \/>\ncommon data-management platform promise to increase agility.\n<\/p>\n<p>\nThis added flexibility will enable quicker response to market needs, allowing sponsors and CROs to shift<br \/>\neffortlessly from functional service partnerships (FSPs) to full-service outsourcing (FSO) business models<br \/>\ndepending on each project\u2019s needs. The new approach to data management will also facilitate the use of<br \/>\nadvanced technologies such as artificial intelligence (AI) and machine learning (ML).\n<\/p>\n<p>\nPartnering with Veeva Systems, Syneos Health has developed the foundation needed for flexibility and integration.<br \/>\nBased on the organization\u2019s successful adoption of Veeva eTMF, clinical leaders decided to partner with<br \/>\nVeeva to establish a modern foundation for clinical data management, planning to centralize data management<br \/>\nby rolling out Veeva Clinical Data, including the platform\u2019s clinical workbench, CDB, internally and with clients.\n<\/p>\n<p>\nLakin sees CDB, which reduces process steps by allowing remote patient data to be cleaned, stored, and<br \/>\nprocessed centrally (<strong>Figure 1<\/strong>), as a key market differentiator for the CRO. Now that Syneos Health has gained<br \/>\nexperience using CDB with multiple clients, senior managers plan to establish a Center of Excellence for CDB<br \/>\nwithin the company.\n<\/p>\n<div style=\"background-color:#f5f5f5;padding:25px 15px;text-align:center;margin:10px 0 20px 0\">\n<h4>FIGURE 1 \u2013 WITH VEEVA CDB, SYNEOS HEALTH ELIMINATES <br class=\"visible-lg\"><br \/>\nTIME-CONSUMING MANUAL DATA-RECONCILIATION STEPS<br \/>\n<\/h4>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/06\/How-Syneos-Health2.png\" alt=\"\" class=\"img-responsive\" \/>\n<\/div>\n<h2> Significant gains in operational excellence<\/h2>\n<p>\nImprovements achieved with Veeva CDB add to the significant efficiency gains that Syneos Health has realized<br \/>\nwith Veeva EDC (<strong>Figure 2<\/strong>). During the UAT cycles prior to go-live and for amendments, Veeva EDC reduces<br \/>\nthe testing burden to only what has changed and eliminates all the testing associated with custom functions.\n<\/p>\n<div style=\"background-color:#f5f5f5;padding:25px 15px;text-align:center;margin:10px 0 20px 0\">\n<h4>FIGURE 2 \u2013 USING VAULT EDC, SYNEOS HEALTH HAS HALVED UAT TIMES<br \/>\n<\/h4>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/06\/How-Syneos-Health3.png\" alt=\"\" class=\"img-responsive\" \/>\n<\/div>\n<p>\nOn a broader level, use of Veeva Clinical Data allows Syneos Health data management teams the ability to rethink<br \/>\nprocesses and their design and make improvements as they integrate applications within the new platform.<br \/>\nHaving all clinical data in one place enables users to study trends and generate reports secure in the knowledge<br \/>\nthat all the information is clean, complete, and up to date.\n<\/p>\n<p>\nAnother major gain has been improved user experience \u2014 not just for sponsor or CRO data managers but for<br \/>\nusers at research sites and for monitors. Each type of user is assigned an interface that has been optimized<br \/>\nfor the work they do, whether data entry or verification. \u201cVeeva Clinical Data makes the data management job easier,\u201d<br \/>\nsays Lakin.\n<\/p>\n<p>\nBut achieving maximum value from Veeva\u2019s platforms requires an agile approach and a long-term view.<br \/>\n\u201cVeeva EDC is not just an EDC replacement that you\u2019d drop in,\u201d emphasizes Trevor Griffiths, senior director of data<br \/>\nmanagement at Syneos Health. His team optimized results by viewing implementation as a journey of change,<br \/>\nand a way to drive process improvement throughout the organization. Veeva has played a key role in driving<br \/>\npositive change, says Lakin.\n<\/p>\n<blockquote><p>\n&#8220;Veeva CDMS makes the data management job easier.&#8221;<br \/>\n<span>\u2014 Nick Lakin, senior managing director at Syneos Health<\/span>\n<\/p><\/blockquote>\n<h2>Best practices start at the planning stage<\/h2>\n<p>\nSucceeding with implementation requires clear focus, not only on change management and process optimization,<br \/>\nbut on end-to-end data flow. As Lakin puts it, \u201cWhat would be the use of having the world\u2019s fastest study build if<br \/>\nyou\u2019ve only shifted the rate-determining step from one place to another?\u201d\n<\/p>\n<p>\nAs with any significant process improvement, change management must be addressed thoughtfully when<br \/>\nmoving to CDMS. \u201cYou can\u2019t just build the system and hope they will come,\u201d Lakin says. \u201cExpect resistance to<br \/>\nchange but consider carefully how to bring teams along with you on the journey.\u201d He suggests that an effective<br \/>\ncommunications strategy be developed concurrently with implementation and training plans. For Syneos Health,<br \/>\nregular knowledge-sharing sessions from teams that had rolled out the application helped create momentum<br \/>\nand faster user acceptance.\n<\/p>\n<p>\nThe company also facilitated change by creating a methodology for improving and standardizing processes<br \/>\nand recruiting subject matter experts for an early adopter team to run through the proposed process changes.<br \/>\nThe team analyzed existing materials including SOPs and supporting templates, as well as standards, normal<br \/>\nranges, and how-to guides, then performed gap analyses to determine what enhancements were needed to<br \/>\nreflect the new processes.\n<\/p>\n<p>\nUpdates and enhancements had been a gray area with past technology partners, but Veeva offered the team<br \/>\ntransparency on what would be possible and when. Each new release of Vault EDC delivered enhancements that<br \/>\nfurther improved cycle times. \u201cTesting new releases of Veeva EDC is completed in half the time required for other<br \/>\nEDC systems,\u201d Lakin notes.\n<\/p>\n<p>\nVeeva CDB also enables improvement by automating pre-processing and storing clinical data in a central<br \/>\nlocation. The traditional approach to generating listings involved multiple steps. First, a data-management team<br \/>\nwould have to ask its EDC vendor to extract data. They\u2019d then put that data on a server, run some SAS jobs,<br \/>\ndevelop programs to create the listings, run those listings, and export them to data management. Using CDB<br \/>\nand pre-processed data, teams simply open listings that have already been generated and appear in one place.<br \/>\nThey no longer need to transfer data between different applications. The application also sends messages<br \/>\nto lab vendors and enables batch queues to be run automatically.\n<\/p>\n<h2>Business model flexibility and an entry point to advanced technologies<\/h2>\n<p>\nHaving data in one place enables greater business model flexibility, allowing CROs to have one single data and<br \/>\nresource pool so that they can use both FSP and FSO approaches to working with partners, shifting from one to<br \/>\nthe other depending on sponsor and business needs.\n<\/p>\n<p>\nThis approach not only improves consistency, but standardizes reporting models and provides comparable<br \/>\nmetrics for both FSO and FSP data. It also enhances skill sets, enabling CRO data management teams to<br \/>\nexecute both models easily. \u201cYou\u2019re sharing best practices, enabling standardization and greater transparency.<br \/>\nIt also simplifies governance so you\u2019re not burdening sponsors with multiple governance models,\u201d says Lakin.<br \/>\n\u201cProviding one common platform for delivery by a sponsor or a CRO, in turn, enables the use of algorithms that<br \/>\ncan be deployed from one to the other,\u201d Lakin explains. This includes the use of AI and ML to automate the<br \/>\nprocess of checking for clinical data anomalies.\n<\/p>\n<p>\nCurrently, the industry uses manual methods to review and trend data to find outliers, creating a time-consuming<br \/>\nbottleneck to greater efficiency. Using advanced technology, data managers could automatically find problems<br \/>\nand confirm that they\u2019ve been addressed or corrected. Syneos Health is exploring the possibilities for AI and<br \/>\nML in clinical data management with companies that include CluePoints and RxDataSciences. \u201cImagine a world<br \/>\nin which two CROs or a CRO and a technology partner race to develop the best algorithms, and sponsors get to<br \/>\npick the best one and figure out how to deploy it. This is where things get exciting,\u201d says Lakin.\n<\/p>\n<p>\nThese improvements, however, depend on a foundation of agility and accuracy. For Syneos Health, collaboration<br \/>\nwith Veeva and use of Veeva CDMS, featuring Vault EDC and Veeva CDB, has helped the company\u2019s clinical data<br \/>\nteams tackle the five V\u2019s (volume, velocity, variety, veracity, value) and respond more nimbly to change as clinical trials and data management continue to evolve.\n<\/p>\n<p>\nIn two video interviews and a <a target=\"_blank\" href=\"https:\/\/www.youtube.com\/watch?v=2AGP9xzAvQo&#038;ab_channel=VeevaSystemsInc\" rel=\"noopener noreferrer\">podcast<\/a>, Trevor Griffiths, senior director of clinical data management, shares insights into how the industry is moving from clinical data management to clinical data science, and how Syneos Health is advancing science-based clinical data management with <a href=\"https:\/\/www.veeva.com\/eu\/customer-stories\/customer-stories-accelerating-study-builds-with-veeva-vault-edc\/\"> Veeva EDC<\/a> and <a href=\"https:\/\/www.veeva.com\/eu\/customer-stories\/syneos-health-transforms-clinical-data-management-with-veeva-clinical-database\/\">Veeva CDB<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>An agile, science-based approach and close collaboration with Veeva are helping the CRO respond nimbly to changing needs. <\/p>\n","protected":false},"featured_media":62752,"parent":0,"template":"","product-link-list":[1393,1395],"class_list":["post-71374","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-clinical-operations","product-link-list-veeva-commercial-cloud"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO Pro 5.0.1 - aioseo.com -->\n\t<meta name=\"description\" content=\"An agile, science-based approach and close collaboration with Veeva are helping the CRO respond nimbly to changing needs.\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<link rel=\"canonical\" href=\"https:\/\/www.veeva.com\/eu\/customer-stories\/speeding-the-shift-to-science-based-data-management\/\" \/>\n\t<meta name=\"generator\" content=\"All in One SEO Pro (AIOSEO) 5.0.1\" \/>\n\t\t<meta property=\"og:locale\" content=\"en_US\" \/>\n\t\t<meta property=\"og:site_name\" content=\"Veeva Systems Europe\" \/>\n\t\t<meta property=\"og:type\" content=\"article\" \/>\n\t\t<meta property=\"og:title\" content=\"How Syneos Health is Speeding the Shift to Science-Based Data Management | Veeva Systems Europe\" \/>\n\t\t<meta property=\"og:description\" content=\"An agile, science-based approach and close collaboration with Veeva are helping the CRO respond nimbly to changing needs.\" \/>\n\t\t<meta property=\"og:url\" content=\"https:\/\/www.veeva.com\/eu\/customer-stories\/speeding-the-shift-to-science-based-data-management\/\" \/>\n\t\t<meta property=\"og:image\" content=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2023\/06\/How-Syneos-Health-is-Speeding-the-Shift-to-Science-Based-Data-Management_Linkedin-1.png\" \/>\n\t\t<meta property=\"og:image:secure_url\" content=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2023\/06\/How-Syneos-Health-is-Speeding-the-Shift-to-Science-Based-Data-Management_Linkedin-1.png\" \/>\n\t\t<meta property=\"article:published_time\" content=\"2023-06-12T20:54:53+00:00\" \/>\n\t\t<meta property=\"article:modified_time\" content=\"2026-08-24T14:05:08+00:00\" \/>\n\t\t<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n\t\t<meta name=\"twitter:title\" content=\"How Syneos Health is Speeding the Shift to Science-Based Data Management | Veeva Systems Europe\" \/>\n\t\t<meta name=\"twitter:description\" content=\"An agile, science-based approach and close collaboration with Veeva are helping the CRO respond nimbly to changing needs.\" \/>\n\t\t<meta name=\"twitter:image\" content=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2023\/06\/How-Syneos-Health-is-Speeding-the-Shift-to-Science-Based-Data-Management_Linkedin-1.png\" \/>\n\t\t<script type=\"application\/ld+json\" class=\"aioseo-schema\">\n\t\t\t{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.veeva.com\\\/eu\\\/customer-stories\\\/speeding-the-shift-to-science-based-data-management\\\/#breadcrumblist\",\"itemListElement\":[{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/www.veeva.com\\\/eu#listItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.veeva.com\\\/eu\",\"nextItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/www.veeva.com\\\/eu\\\/customer-stories\\\/#listItem\",\"name\":\"C. 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