Learn how Boehringer Ingelheim successfully converted their bioanalytical reports to automated reporting in a very short time, and the challenges the world’s leading pharmaceutical company faced.<\/p>\n
The StudyReporter Bioanalytics project <\/span>was implemented from October 2009 <\/span>to February 2010 and was integrated <\/span>into Boehringer Ingelheim’s software <\/span> environment. This allowed Boehringer <\/span>Ingelheim to benefit from an extremely <\/span>expeditious roll-out phase, as well as very <\/span>low validation effort.<\/span><\/p>\n However, the measure of the success <\/span>of up to data’s Boehringer Ingelheim <\/span>solution only becomes clear when the <\/span>process-oriented approach enabled <\/span>by StudyReporter is compared with<\/span> Boehringer Ingelheim decided to <\/span>implement the Watson LIMS from <\/span>Thermo Fisher Scientific as part of the <\/span>replacement project for its proprietary <\/span> bioanalytical laboratory LIMS. During the implementation<\/span> phase, it was unveiled <\/span>that the new solution did not provide <\/span>an adequate automated procedure for <\/span>generating the required regulatory <\/span>bioanalytical reports.<\/span> up to data’s StudyReporter Bioanalytics <\/span>application provides an open, <\/span>configurable solution for generation of <\/span>eCTD-compliant bioanalytical reports <\/span>retrieving data from Thermo Scientific\u2122<\/span> Bioanalytical reports intended for regulatory submission are complex documents that are subject to various requirements in respect to authorities, internal SOPs and corporate policy. Due to the seamless integration of StudyReporter with the Watson LIMS and the numerous standard options offered, almost all of Boehringer Ingelheim’s specifications could be met Thanks to up to data’s efficient and transparent project plan, Boehringer Ingelheim’s solution could be rolled out rapidly. In order to indicate the exact costs of the solution up front, up The iterative approach used by up to data facilitated testing of previously implemented functions via defined cycles – which in turn made it possible to verify that the solution met the Dr. Martina Wein, LIMS project manager was extremely pleased with the highly successful outcome of the implementation: „We were able to implement the project very quickly. The up to data solution was integrated seamlessly in the customer’s IT environment, enabling automated and validated workflows, from study planning to report management.<\/p>\n <\/p>\n StudyReporter Bioanalytics was previously known as iStudyReporter Bioanalytics. As part of a redesign and rebranding, the reporting solution is now part of the StudyGen 360 lab data platform and covers the report generation portion of the application family as StudyGen Reporter Bioanalytics or StudyReporter Bioanalytics for short.<\/strong><\/p>\n
the labor-intensive report generation <\/span>procedure the customer was using <\/span> previously. The outstanding efficiency of the <\/span>StudyReporter process makes generation of <\/span>complex reports far less labor-intensive, while <\/span>at the same time allowing for totally secure <\/span>data transfer.<\/span><\/p>\nChallenge<\/h2>\n
Additionally, the customer wanted to <\/span>implement the new automated solution <\/span>as quickly as possible to avoid <\/span>undermining the efficiency of the <\/span>replacement project as a whole.<\/span><\/p>\nSolution<\/span><\/h2>\n
Watson LIMS\u2122. <\/span>StudyReporter’s virtually complete <\/span>coverage of bioanalytical report <\/span>elements (e.g. preformatted texts, tables <\/span>and statistics) allowed the customer <\/span>to implement a solution that meets <\/span>Boehringer Ingelheim’s requirements very well. <\/span><\/p>\nAdvantages<\/span><\/h2>\n
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A configurable solution versus individual programming<\/h2>\n
\nWhat’s more, the need for a completely secure data transfer process makes bioanalytical report generation a labor-intensive task that often has to be performed by a number of specialists.
\nBoehringer Ingelheim decided in favor of up to data’s StudyReporter Bioanalytics solution because it allows for efficient use of the customer’s existing Watson LIMS.<\/p>\n
\nsimply and easily by configuring tables and templates and without additional programming.<\/p>\nAn efficient implementation plan<\/h2>\n
\nto data held a special workshop with the customer based on typical study data and current report templates. The workshop provided all participants with clear information regarding the project’s implementation, customization, and validation costs. up to data’s precisely structured project supported the defined schedule and allowed for accurate planning and deployment of project resources.<\/p>\n
\ncustomer’s needs in his environment. During this process, key users received the requisite intensive training, and thus were efficiently integrated into the roll-out process, thereby ensuring
\nthe implementation of the customer’s specifications at all times.<\/p>\n
\nWhat’s more, we obtained an intelligent solution that meets our requirements, but that still leaves room for change.“<\/p>\n