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<h1 class="sidebarhead">SELECTED WORK</h1>
<ul class="sidebarlist"><li><a href="../downloads/ABS_CinicalTrials.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>Clinical Trials </h1>
<p>The ABS team offers expert support for Phases II–IV clinical trials from design and management through regulatory consultation and reporting. We have over 20 years of proven experience conducting trials for drugs, biologics, and medical devices across a wide range of therapeutic areas.</p>
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<li> Protocol design and development</li>
<li>Investigator recruitment</li>
<li>Institutional Review Board consultation</li>
<li>Negotiation and management of investigator grants</li>
<li>Patient recruitment </li>
<li>Site training and support</li>
<li>Site and data monitoring and auditing</li>
<li>Sample size and power calculations</li>
<li>Randomization codes</li>
<li>Regulatory filings </li>
<li>Medical evaluation and safety reporting</li>
<li>Project management </li>
<li>Clinical data management </li>
<li>Efficacy and safety statistical analyses </li>
<li>Report and manuscript writing</li>
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