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<!DOCTYPE html> <html> <head> <meta charset='utf-8'> <meta content='IE=9; IE=8; IE=7; IE=edge; chrome=1' http-equiv='X-UA-Compatible'> <meta content='width=device-width, initial-scale=1.0' name='viewport'> <title>Clinical Trial Management System</title> <meta content='Clinical Trial Management System' name='description'> <script src='https://cdnjs.cloudflare.com/ajax/libs/d3/3.5.17/d3.min.js'></script> <link rel="stylesheet" media="all" href="/assets/application-2b88168023166027c3927451ba5fe5884d3dd17f8a1146f1a59a6f2f3bdf402c.css" data-turbolinks-track="true" /> <script src="/assets/application-867a943759c53b40098556f2079629e8a4cf80a6e8bdb9d566fcd25c5011e8ca.js"></script> <meta name="csrf-param" content="authenticity_token" /> <meta name="csrf-token" content="jUODNIF7mO6JPT2vtP14TWvWpuyMasTXRBNLGsM1DtDyx7oc5x9WGrd4Fygfno0ypKJ9ZmtmsHHZn2zr5zUiIw==" /> <script> //<![CDATA[ (function(i,s,o,g,r,a,m){ i['GoogleAnalyticsObject']=r;i[r]=i[r]||function(){ (i[r].q=i[r].q||[]).push(arguments)},i[r].l=1*new Date();a=s.createElement(o), m=s.getElementsByTagName(o)[0];a.async=1;a.src=g;m.parentNode.insertBefore(a,m) })(window,document,'script','//www.google-analytics.com/analytics.js','ga'); ga('create', 'UA-34837111-8', 'harvard.edu'); ga('send', 'pageview'); //]]> </script> </head> <body> <div class='container'> <header> <a href="/"><img id="logo" alt="Translational Medicine Group - Bringing New Therapeutics Into Focus" src="/assets/logos/tmg-7d0212e8dabbd693879daaa51b7052818e92dc9451fd7b3ef21888e6ab61e00c.png" /></a> </header> </div> <nav> <nav class='navbar navbar-default' role='navigation'> <div class='container'> <div class='navbar-inner'> <div class='navbar-header'> <button class='navbar-toggle collapsed' data-target='#i3-nav-collapse' data-toggle='collapse' type='button'> <span class='sr-only'>Toggle navigation</span> <span class='icon-bar'></span> <span class='icon-bar'></span> <span class='icon-bar'></span> </button> </div> <div class='collapse navbar-collapse' id='i3-nav-collapse'> <ul class='nav navbar-nav'> <li class='dropdown'> <a class='dropdown-toggle' data-toggle='dropdown'> Services <span class='caret'></span> </a> <ul class='dropdown-menu' role='menu'> <li> <a href="/services">Services</a> </li> <li> <a href="/services/nonclinical-development">Non-Clinical Development</a> </li> <li> <a href="/services/chemistry-manufacturing-controls">Chemistry Manufacturing & Controls</a> </li> <li> <a href="/services/regulatory-affairs">Regulatory Affairs</a> </li> <li> <a href="/services/clinical-development">Clinical Development</a> </li> <li> <a href="/services/clinical-database-platform">Clinical Database Platform</a> </li> <li> <a href="/services/clinical-trial-management-system">Clinical Trial Management System</a> </li> <li> <a href="/services/contracts-regulations">Contracts & Regulations</a> </li> </ul> </li> <li> <a href="/experience">Experience</a> </li> <li> <a href="/research">Research</a> </li> <li class='dropdown'> <a class='dropdown-toggle' data-toggle='dropdown'> About <span class='caret'></span> </a> <ul class='dropdown-menu' role='menu'> <li> <a href="/about">About</a> </li> <li> <a href="/about/who-we-are">Who we are</a> </li> </ul> </li> <li> <a href="http://www.massgeneral.org/news/">News</a> </li> <li> <a href="/contact">Contact</a> </li> </ul> <ul class='nav navbar-nav navbar-right'> <li> <form class="button_to" method="get" action="/login"><input class="btn btn-default" type="submit" value="Login" /></form> </li> </ul> </div> </div> </div> </nav> </nav> <main class='container fixed-width' role='main'> <div class='static-layout'> <div class='content' id='content'> <ul class="wiki_page_actions"> </ul> <div class="wiki_content fr-view"> <p><br></p><h2>Program <span>Management</span> Services</h2><p>The Translational Medicine Group strives to accelerate the translation of scientific discoveries into innovative diagnostics and therapies for disease prevention and improved health care delivery. Our developmental services enable accelerated and cost effective translation of discovery stage therapeutics into new medical solutions.</p><p class="bold">Our services include:</p><ul> <li>Program planning<ul> <li>Target Product Profile definition</li> <li>Timeline, budget, and resources</li> </ul> </li> <li>Vendor management<ul><li>Identification, qualification and negotiation</li></ul> </li> <li>Clinical & nonclinical trials<ul> <li>Protocol design</li> <li>Operational feasibility</li> <li>Conduct</li> </ul> </li> <li>Preclinical and clinical trial conduct monitoring<ul> <li>GCP/ GLP compliance</li> <li>Data management & review</li> </ul> </li> <li>Chemistry Manufacturing & Controls</li> <li>Regulatory strategy & filings<ul> <li>Interaction with regulatory agencies (briefing packages, meeting attendance)</li> <li>Generate summary documents</li> <li>Prepare and manage eCTD & CTA submissions</li> </ul> </li> <li>Mechanistic study coordination<ul> <li>Sample collection and processing</li> <li>Central pathology review</li> </ul> </li> </ul> </div> </div> </div> </main> <footer> <div class='fixed-width'> </div> <div class='footer-bg-cta'> <h3>Get started Today!</h3> <a class='btn btn-lg btn-primary' href='/contact'> Contact Us <i class='fa fa-chevron-right'></i> </a> </div> <div class='footer' role='contentinfo'> <div class='footer-logo'> <a href="http://hms.harvard.edu"><img src="/assets/static_site/footer-logo-harvard-fb01b726d0d5ad1115df89a310bcfcb5c5b47003a7e871e352fcdf8d2e3a7367.jpg" alt="Footer logo harvard" /></a> <a href="http://www.partners.org"><img src="/assets/static_site/footer-logo-partners-40e790a7392280b0a8cfedb9b155ae8177ea11856ad911e33c32780d73d5b7ab.jpg" alt="Footer logo partners" /></a> <a href="http://massgeneral.org"><img src="/assets/static_site/footer-logo-mgh-340c2259e4bab858c85028aafdd600de00242274bb0211f32905b7f150a0b721.jpg" alt="Footer logo mgh" /></a> </div> <div class='footer-links'> <ul> <li> <a href='/'>Home</a> </li> <li> <a href='/services'>Services</a> </li> <li> <a href='/experience'>Experience</a> </li> <li> <a href='/research'>Research</a> </li> <li> <a href='/about'>About</a> </li> <li> <a href='/news'>News</a> </li> <li> <a href='/contact'>Contact</a> </li> </ul> </div> <address> <strong>Massachusetts General Hospital</strong> <br> Richard B. 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