{"id":83744,"date":"2025-04-19T00:12:08","date_gmt":"2025-04-18T22:12:08","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=83744"},"modified":"2026-04-21T11:57:26","modified_gmt":"2026-04-21T09:57:26","slug":"fast-and-successful-edc-study-builds-with-veeva-clinical-data","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/fast-and-successful-edc-study-builds-with-veeva-clinical-data\/","title":{"rendered":"Customer Story"},"content":{"rendered":"

\nMost lay people may think that late-stage change requests are the exception and not the rule, but if you poll data managers you\u2019d hear they are the norm. That was the case for this 400-person biopharma.\n<\/p>\n

\nDuring their first study with ³Ô¹Ï±¬ÁÏ EDC there was a late-breaking shift in strategy. Their Phase II early stage feasibility study in a new indication turned into the program-leading first trial. As they were finalizing the database build, the Medical Director recommended that they establish data collection standards for the new indication\u2014starting with this first study.\n<\/p>\n

\n\u201cIt was a total change in mindset and late in the game. It would be a crunch to maintain existing timelines.\u201d
\n– Director of Data Management, Multi-national Biopharma<\/span>\n<\/p><\/blockquote>\n

The People, Processes, and Technology that Made it Possible<\/h2>\n

\n³Ô¹Ï±¬ÁÏ\u2019s Agile Design process for building case report forms (eCRFs) was particularly helpful. Of the thirty final eCRFs, twenty-two were built directly from the protocol. Standard edit checks (dates, ranges, and missing data) were completed without needing specifications. The study-specific checks, including cross-form validations and complex calculations, were completed within a week.\n<\/p>\n

An Interactive Design Review Meeting with Real-time Updates to the Study<\/h4>\n

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\n\u201cData collection designs can be sub-optimal at times when programmers work strictly from specifications. We appreciated having study designers who were also data managers building our forms.\u201d
\n– Director of Data Management, Multi-national Biopharma<\/span>\n<\/p><\/blockquote>\n

\nOnce the eCRFs were completed, ³Ô¹Ï±¬ÁÏ sent annotated PDFs, an auto-generated specifications document, and links to the live development environment where people could review the actual casebook forms. The lead data manager gathered preliminary feedback, which ³Ô¹Ï±¬ÁÏ incorporated prior to the live Design Review and Decisions Workshop.\n<\/p>\n

\nIn the workshop, study team members were able to see in real time what their proposed changes looked like. The director of data management recalls, \u201cThere was lots of back-and-forth between our internal functions. We\u2019d say, \u2018Is this what we want? No, could we make it look like this? Oh, well, on second thought\u2026 let\u2019s make it this way\u2019.\u201d Given the new therapeutic area, there were lots of unknowns and discussion needed. This made seeing and discussing the updates in real time critical to hitting their deadline.\n<\/p>\n

\n\u201cMost of the changes were implemented right in front of our eyes, which was extremely helpful to making decisions and hitting our deadline.\u201d
\n\u2013 Director of Data Management, Multi-national Biopharma<\/span>\n<\/p><\/blockquote>\n

\nThroughout the development process, the teams were in close communication. The sponsor had direct access to the development sandbox, and could review and approve the updates as work progressed. Rather than use email, they kept a shared online change log. The sponsor used the log to specify requests and ³Ô¹Ï±¬ÁÏ used it to request clarifications and track completed work. The shared view allowed both teams to move quickly and keep in lockstep regarding what had been implemented and what hadn\u2019t.\n<\/p>\n

Facing Last-minute Changes \u2013 Four Keys to Success<\/h4>\n

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Overview: An Agile Design Process with ³Ô¹Ï±¬ÁÏ Clinical Data<\/h3>\n

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Most lay people may think that late-stage change requests are the exception and not the rule, but if you poll data managers you\u2019d hear they are the norm. That was the case for this 400-person biopharma. During their first study with ³Ô¹Ï±¬ÁÏ EDC there was a late-breaking shift in strategy. Their Phase II early stage…<\/p>\n","protected":false},"featured_media":0,"parent":0,"template":"","product-link-list":[],"class_list":["post-83744","customer-stories","type-customer-stories","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/83744"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":1,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/83744\/revisions"}],"predecessor-version":[{"id":83811,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/83744\/revisions\/83811"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=83744"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=83744"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}