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<h1 class="sidebarhead">SELECTED WORK</h1>
<ul class="sidebarlist"><li><a href="../downloads/ABS_Biometrics.pdf">Fact Sheet</a> <img src="../images/pdf.gif" alt="Download PDF" width="16" height="16" align="absmiddle" /></li>
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<p>Kay Larholt, Sc.D.<br />
Vice President<br />
Abt Bio-Pharma Solutions, Inc.<br />
781.372.6622<br />
<a href="mailto:[email protected]">[email protected]</a></p>
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<h1>Biometrics </h1>
<p>ABS offers a comprehensive set of integrated biometrics services that provide accurate and reliable data from clinical trials, patient and disease registries, and epidemiology studies. From study planning and design through analysis and reporting, the ABS team helps to optimize the value of healthcare research. </p>
<h3>Design</h3>
<ul>
<li> Clinical strategy development</li>
<li>Study objectives and endpoints definition</li>
<li>Sample size determination</li>
<li>Protocol development</li>
<li>Randomization</li>
</ul>
<h3>Clinical Data Management Services</h3>
<ul>
<li> CRF design/consultancy</li>
<li>Database design</li>
<li>Data management plans/guidelines</li>
<li>CRF management</li>
<li>Data entry</li>
<li>Coding (MedDRA, WHO-DRUG)</li>
<li>Electronic data capture</li>
<li>Data validation and review</li>
<li>Data migration services</li>
<li>Generation of integrated datasets</li>
<li>Large trial capabilities</li>
<li>Transparent/seamless data conversion</li>
</ul>
<h3>Statistical Analysis and Reporting</h3>
<ul>
<li> Statistical methods and analysis plan development</li>
<li>Statistical programming of Tables, Listings and Figures</li>
<li>Analyses of efficacy and safety</li>
<li>Support for Data Monitoring Committees (DMCs)</li>
<li>Clinical study reports</li>
<li>Integrated Summaries of Safety and Efficacy (ISS/ISE)</li>
<li>FDA and regulatory agency representation</li>
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