\nThe combined site and CRO now delivers EDC study builds in two to three weeks.\n<\/p>\n
\nMany patients who suffer from acute or chronic pain depend on
\ntreatments that were tested at Lotus Clinical Research. Established
\nby anesthesiologist Dr. Neil Singla in 2001, the privately-owned
\ncompany started off as a clinical research site, building a reputation
\nfor compliance, speed, and effective patient recruitment.\n<\/p>\n
\nOver time, sponsors started to ask Lotus to run their studies,
\nand the company took on projects that would normally be handled
\nby external contract research organizations (CROs). As this side
\nbusiness took on a life of its own, the company had to develop an
\neffective growth strategy.\n<\/p>\n
\nIn 2013, Lotus recruited Eric Guitard, now director of systems integration, to grow its CRO. \u201cWe wanted to build
\nsomething new that would evolve as the CRO grew, rather than use 20-year-old technology with incremental
\nadditions,\u201d says Guitard, who was named a 2021 Veeva Hero for his leadership in implementing Veeva Clinical Data.\n<\/p>\n
“The EDC is no longer the bottleneck in study startup.
\nWe are reducing overall study start times from three months to
\nfour-to-five weeks using Veeva\u2019s Clinical Platform.”
\nEric Guitard, Vice President of Systems Integration, Lotus Clinical Research<\/span>\n<\/p><\/blockquote>\n\nLotus first implemented Veeva eTMF and Veeva CTMS applications. Lotus\u2019s previous eTMF had limited functionality and wasn\u2019t user friendly, says Guitard. \u201cSome eTMFs are glorified file servers; they create more problems than simply using a paper TMF,\u201d he says.\n<\/p>\n
\nIn 2019, the company rolled out Veeva EDC and Veeva Coder, part of Veeva Clinical Data. \u201cWhat was most appealing was the fact that the platform is highly intuitive and would exchange data with our clinical Vault,\u201d Guitard says.\n<\/p>\n
\nWhat sold him on Veeva was the ease of integration possible between the company\u2019s Vault applications.
\n\u201cWith other systems out there, you\u2019re given silos that take considerable time and effort to connect. We wanted
\na solution that would work out of the box and that was completely validated,\u201d said Guitard.\n<\/p>\nCDMS design speeds study builds<\/h2>\n
\nFor the first two years, Veeva\u2019s services team built the casebooks and edit checks for Lotus\u2019s trials. Shortly after Veeva released the Vault Studio design environment in Veeva EDC, Lotus got trained to build their own studies. The Studio environment for designing casebooks within Clinical Data is so user-friendly that data managers can build most of the studies themselves, involving programmers only for complex functions. \u201cHaving them build forms right in Studio, without writing specs first in MS Word, helps us move much faster than we could before,\u201d Guitard explains.\n<\/p>\n
\nAs a result, setting up an EDC, which used to take eight or nine weeks, can now be done in three, or sometimes even two weeks, he says. Studio also enables study elements including visits, forms, and rules from previous studies to be reused and configured as needed. \u201cIf you give me a reasonable protocol that\u2019s similar to other studies we have done in the past, I can usually get a solid draft to present to the sponsor within four days,\u201d he says.\n<\/p>\n
\nWith other EDCs, Guitard explains, building casebooks took so long that the team had to start with early drafts of a protocol in order to finish the build on time. As the protocol evolved, making changes was a painstaking process that required ongoing and time-consuming reviews. Now, Lotus teams can work with protocols that are close to being finalized, which saves a significant amount of time and enables a faster response when changes are needed. As a result, the EDC is no longer the bottleneck in study startups. \u201cNow, the clinical team needs to hurry to keep up. With everyone moving faster, we can reduce overall study start times from three months to four weeks,\u201d notes Guitard.\n<\/p>\n
Ready to scale<\/h2>\n
\nThe flexibility and agility Lotus has gained with Veeva Clinical Data have been crucial to the CRO\u2019s growth so far,
\nespecially as it aims to become an extension of each sponsor\u2019s team. Lotus works side by side with clients,
\nmainly with startups and small pharma companies, to walk through any regulatory issues that come up.
\n\u201cThey have to pivot, and we need to pivot right along with them,\u201d Guitard says.\n<\/p>\n\nIt was also important to have a system in place that could scale easily, since the company has grown beyond
\nthe point where one person can manage all its clinical programs. Until 2021, Guitard managed 10 to 12 studies a
\nyear by himself. He then hired a full-time manager for Veeva eTMF and Veeva CTMS, as well as a programmer for
\nVeeva Clinical Data. \u201cVeeva clinical applications are very easy to use. We\u2019ve been able to get a lot of work done without
\nany issues, including one Phase III study that went to registration. We were audited by the FDA and had zero
\nfindings,\u201d he notes.\n<\/p>\n\nNow that its CRO business is in high-growth mode, Lotus is focusing on utilizing more of Vault\u2019s capabilities.
\n\u201cWe have a direct line of communication with Veeva\u2019s team, and we feel that our requests are being heard.
\nThe system has really changed the way we run clinical trials,\u201d Guitard says.<\/p>\n","protected":false},"excerpt":{"rendered":"The combined site and CRO delivers EDC study builds in two to three weeks with Veeva Clinical Platform.<\/p>\n","protected":false},"featured_media":89976,"parent":0,"template":"","product-link-list":[],"class_list":["post-64937","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64937"}],"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":3,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64937\/revisions"}],"predecessor-version":[{"id":83519,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64937\/revisions\/83519"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/89976"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=64937"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=64937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}