|
|||||||||||||||||||||||||||||||
![]() |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Company Background This Organization is a research-oriented, multinational, pharmaceutical company. It strives to benefit patients by providing new and improved treatments for diseases and their symptoms and seeks to continually develop and sell new, high quality, innovative, pharmaceutical preparations, which, together with clinical data and medical education, create new value for patients and the health care system. The Organization is engaged in the research, development, marketing, sales and distribution and licensing of prescription pharmaceuticals, over-the-counter medications and hospital products. Objectives This Organization has an application that was written in-house. This complex package was developed to perform safety and efficacy analysis on their drugs for reporting to the FDA. This system was designed to track the multitude of information collected for such rigorous analyses. After writing their own complex application, the Company realized that their forte and future development was not in designing software. They decided to outsource the support of this system. They needed an organization that would be able to learn their existing application and support their needs in the United States, England, Canada and Germany. Resolutions Our personnel were trained by the Organization's software developers in the United States who, in turn, went back to the different countries to support local offices in the use and enhancement of the application. Once we learned how their system was written and how it works we started supporting them at all their different global locations. Benefits The Organization achieved its goal. It no longer has to support its complex application system in-house. This results in cost savings where they no longer have to dedicate in-house resources to support and maintain the system. Also, the Organization has the convenience of communicating with one single point of contact in the United States, while support is provided to multiple global locations. Additional ProjectsSuccess Story 2 This Organization is the focal point for a State's Department of Health Services injury prevention efforts, both epidemiological investigations and implementation of prevention programs to reduce intentional and unintentional injuries. Prevention efforts include epidemiological surveillance, planning and consensus building, interventions, policy development, professional education and training, and public information dissemination. We are currently assisting this branch in its effort to make injury related data available to the public. Currently, the only means for the public to obtain injury related statistics is by calling the branch and making a request. This branch then does the necessary programming to generate the requested information. This is a time consuming and costly task for this organization's personnel. The Organization decided it was time to use the web to its advantage and to allow the public to easily access injury data from their web site. The data was in a table and the organization needed a company that had both programming and Web expertise. We have both web and application development capabilities and can tie the two together. It was this combination of skills that drove the organization to hire our consulting resources for this project. Success Story 3 Destiny helped this clinical research organization standardize their edit check processes. The Company was faced with slow turnaround on data flowing through their data management group. They were supporting several clients. They approached us for assistance in streamlining their edit check process. Up to this point, edit checks were very manual and ad hoc in nature, requiring several programmers for each study. Destiny developed a batch edit check process that would automatically analyze case report form data and deliver error reports that could be easily read by non-technical data managers. This production process would run nightly and deliver reports in the morning on all the studies being handled by this CRO. This resulted in a significant reduction in processing time for the edit check part of each study, which resulted in a much quicker response and turnaround time to their clients. Success Story 4 Two longitudinal studies for congestive heart failure were conducted over a ten year period. The first trial involved a three arm comparison of vasodilator drugs against a placebo. The winning therapy was then compared in a second trial with the next generation of drugs, ace inhibitors. The responsibilities of these trials were from CRF design through final statistical analysis. The data processing involved database design, data cleaning, safety reporting , efficacy reporting and mortality analysis. Destiny has been supporting this Organization for several years with various training and consulting projects. Since all of their data was collected on a mainframe environment, they were faced with implementing updated processes to help them exploit the distributed capabilities and features of the Windows operating system. They needed assistance in building Client Server applications. We set up customized training classes for the Company's employees to teach them the benefits of client server processing as it runs in a Windows/NT environment. They learned how to communicate with other programs using DDE and ODBC technology. Mainframe production jobs that processed their data needed to be able to communicate with the Windows/NT environment. We consulted with them to set up spawners in a DHCP environment that would allow mainframe batch jobs to run and automatically deliver the data to the Windows/NT environment for further processing. This technology has helped them leverage their investment in a client server and distributed environment to better process their data and compete in the pharmaceutical industry. Success Story 5 Destiny Consulting was hired by this Organization to assist them in the implementation of software products. Their goal was to publish the case report form and patient data that was updated nightly on the web using HTML and PDF files with bookmarking capabilities. They also saw the FDA moving towards the acceptance of PDF files with bookmarking for electronic submissions. We showed them how to use Software to automate this process where they could have up to the minute reporting and dynamic web pages that could be used by investigators and data managers to better track case report form data and the latest information on their studies. Success Story 6 Destiny Consulting was hired to assist this Organization in creating statistical programs to analyze safety and efficacy data during their Ceftazadine/Cefepime comparison study. The Company created both of these protocols at different times and was interested in comparing the results of the two drugs. We were responsible for creating tabular reports and models for the statisticians to use
|
|||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||