ÿþ<!doctype html public "-//w3c//dtd html 4.0 transitional//en"> <html><head> <!-- CHANGE THE NEXT THREE LINES --> <title>Data Management</title> <meta name="Description" content="Versagenics, Inc. is a next generation clinical research organization (CRO) focusing on data management, biostatistical and medical writing services supporting the pharmaceutical, biotechnology and medical device communities."> <meta name="KeyWords" content="clinical data management, biostatistics, statistics, medical writing, pharmaceutical outsourcing, clinical research, contract research organization, clinical research organization, drug development, consulting, biotechnology, medical device, clinical trial, Donald F. Fortin, M.D., Joe M. 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In addition, our data management and biostatistical approach is aligned with adherence to the FDA's 21 CFR Part 11 and other applicable regulatory guidelines. <p> At Versagenics, we focus our attention on anticipating your needs to provide you with a seamless and well designed clinical trial. Our expert staff are trained to address the varied twists and turns that invariably do occur with every project to provide you with an adaptive and interactive experience. Versagenics knows how to leverage its resources and to intelligently connect all components of the trial to maximize your ability to review our progress and provide oversight.</p> <span class="subtitle"> Case Report Form (CRF) Design and Review </span><br /><br /> The data collection process in a clinical trial involves more than the transcription of data from case report forms into electronic records. It also involves the logical, consistent organization of all electronic information into an easy to review format. To achieve this goal, we define client and/or project specific question libraries which are utilized continuously to provide you with a shortened study startup time and to achieve consistency from project to project. <br /><br /> <span class="subtitle"> Database Design and Data Management </span><br /><br /> Our choice of tools for database creation and dataset extraction and transformation allow Versagenics to leverage your investment to accelerate the development of future projects. To achieve this, we have adopted the CDISC SDTM attributes where possible to provide you with the highest quality data possible. <br /><br /> <span class="subtitle"> CRF Workflow </span><br /><br /> Despite the availability of EDC for decades, the majority of clinical trials are still performed using paper CRFs. Our workflow is highly optimized to allow for a rapid turnaround of data while maintaining quality from the time CRFs arrive. At Versagenics our CRF workflow is designed such that our operatational procedure is to have data entered within 2 business days from the time data is received. We routinely complete the process by issuing queries within 3 business days from the time data is received (as summarized below). <UL> <li>CRF is logged into tracking system and scanned to PDF.</li> <li>Data entry is completed within 2 business days from receipt.</li> <li>Data validation is run every night and on demand.</li> <li>Queries are sent to investigative sites and clinical monitors within 3 business days.</li> <li>Data are reviewed on a concurrent and ongoing basis for database closure within 5 business days after the last query has resolved.</li> <li>At Versagenics, our business motto is 'To deliver on time, or before time, every time!'</li> </UL> <span class="subtitle"> Ongoing Status Reports </span><br /><br /> As business people, we understand the needs of our business clients and have pioneered the development of a series of detailed reports in support of business process management. These reports provide you and the project team with critical information that allows the identification and resolution of process bottlenecks before they arise. <p>Our summary study management reports provide you with critical details regarding the CRF page processing status by site and subject, query status, data clarification form status and age. Clean subject reports provide insight into the progress we are making in resolving outstanding matters for any study subject prior to database freeze. Here at Versagenics, you can 'look over our shoulder' and monitor our progress 24/7! <br /><br /> <span class="subtitle"> Medical Coding </span><br /><br /> Our medical coding services allow us to provide coding using the MedDRA or WHODRUG thesauri. We have extensive experience using these medical dictionaries and we provide physician oversight of this process. <br /><br /> <span class="subtitle"> Data Management Only </span><br /><br /> If you prefer to separate clinical activities from the data management and analysis process, let Versagenics provide you with the high quality data management services you need. To achieve this, we have developed unique infrastructure bridging tools that allow us to: <ul> <li>Design services that integrate seamlessly with multiple other service organizations.</li> <li>Adapt and integrate specific client or clinical team requirements.</li> </ul> <br /> <span class="subtitle"> Data Management Rescue Services </span><br /><br /> <p>Do you have concerns about the progress of your study - you're having trouble obtained information, the data you are provided is inconsistent, the database lock deadlines seem to be slipping? Versagenics understands that project plans can go astray. Our data management processes allow us to rapidly accept, review and determine the optimal strategy for a project that you have concerns about and needs an independent review. Our data management team has extensive experience in every stage of the rescue process, from planning, strategy development to communication and implementation. Versagenics has the experience, skill set, resources and dedication to complete your project. </p> <IMG SRC="picts/paragraph-line.jpg" HEIGHT=3 WIDTH=100% border="0" vspace="7"><BR> <BR><BR> <!-- COPY AND PASTE CODE ABOVE HERE TO MAKE A NEW PARAGRAPH --> <br><br> </p> </td></tr></table> <!-- CONTENT TABLE --> </td></tr></table> <!-- SPLIT TABLE --> </td></tr></table> <!-- OUTER TABLE--> <!-- PAGE TABLE--> </TD></TR><TR><TD VALIGN="BOTTOM"> <script language="JavaScript" src="menu.js"></script> <img src="picts/stretchbar.jpg" width="100%" height="28"><br> <!-- COPYRIGHT --> <TABLE cellpadding="0" cellspacing="0" border="0" width="100%" background="picts/bottom-shade.gif"><tr><td width="10"> <IMG SRC="picts/spacer.gif" height="45" width="10" border="0"><br> </td><td ALIGN="left" VALIGN="center"> <script language="JavaScript" src="copyright.js"></script> </td><td ALIGN="right" VALIGN="center"> <script language="JavaScript" src="copyright-allwebco.js"></script> </TD><td width="10"> <IMG SRC="picts/spacer.gif" height="10" width="10" border="0"><br> </td></tr></table> <!-- COPYRIGHT --> </td></tr></table> <!-- END PAGE TABLE--> </BODY> </HTML>