ÿþ<!doctype html public "-//w3c//dtd html 4.0 transitional//en"> <html><head> <!-- CHANGE THE NEXT THREE LINES --> <title>Medical Writing</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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Our flexible approach allows for: <ul> <li>Selection of &agrave; la carte components (protocol only, clinical study report only, etc.) to complete medical writing projects (protocol through clinical study report). You pick and choose!</li> <li>Use of your document templates or Versagenic's own ICH GCP-compliant document templates. </li> </ul> Services available include: preparing protocols, subject information sheets, narratives, clinical overviews and summaries, clinical study reports, manuscripts, editing, abstracting, translations, literature searches and reviews. <br /><br /> <span class="subtitle">Regulatory Writing <IMG SRC="picts/paragraph-line.jpg" HEIGHT=3 WIDTH=100% border="0" vspace="7"><BR> </span> <span class="subtitle"> Protocols </span><br /><br /> We use our broad therapeutic experience to drive your clinical development plan starting with the drafting of a clinical study concept sheet. We quickly follow this up with the generation of a clinical trial protocol either from information provided by you, from performance of a literature search or a combination of the two. <p>We have provided services for a wide range of therapeutic areas covering phase I  IV clinical and marketing studies, as well as study designs requiring innovative thinking and adaptation. <br /><br /> <span class="subtitle">Clinical Study Reports (CSRs) </span><br /><br /> As part of our &agrave; la carte service we are able to generate clinical study reports for clinical trials in combination with our data management and biostatistical services or as a stand alone service. <p>Versagenics has extensive expert experience with preparing CSRs for Phase I-IV studies. In addition to the writing service, we can supplement this with supportive statistical plans and analyses if desired. If you don't have a CSR template, we can supply an ICH compliant CSR template for use in the project. <br /><br /> <span class="subtitle">Investigator Brochures (IBs) </span><br /><br /> Versagenics can prepare and/or revise IBs. Our staff has the experience to summarize the chemical, pharmacological, toxicological and pharmacokinetic data as well as any available previous human experience information. <br /><br /> <span class="subtitle">INDs </span><br /><br /> We have drafted the clinical development program strategy for IND's. In addition, we have extensive, successful experience with defending the development program strategy at pre-IND meetings with the FDA. <br /><br /> <span class="subtitle">Non-regulatory Writing <IMG SRC="picts/paragraph-line.jpg" HEIGHT=3 WIDTH=100% border="0" vspace="7"><BR> </span> <span class="subtitle">Publications </span><br /><br /> <span class="list"> Versagenics has a lengthy history of generation of publication ready documents including abstracts, full manuscripts, and/or review articles summarizing the results of previous and current clinical research in a wide variety of therapeutic areas. We are able to develop manuscripts for publication from a clinical study report or directly from a statistical package or in the case of review articles from a literature search. Our services are oriented toward supporting the principle investigator in expediting the drafting, generation and submission of the research publication. </span> <BR><BR> <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>