Project Requirements and Compliance | NeoGenomics Laboratories

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type="text" id="edit-phone" name="phone" value="" size="60" maxlength="255" class="form-text" /> </div> </div></div><div class="webform-flex webform-flex--1"><div class="webform-flex--container"><div class="js-form-item form-item js-form-type-select form-type-select js-form-item-country form-item-country"> <label for="edit-country">Country</label> <select data-drupal-selector="edit-country" id="edit-country" name="country" class="form-select"><option value="" selected="selected">- None -</option><option value="Afghanistan">Afghanistan</option><option value="Albania">Albania</option><option value="Algeria">Algeria</option><option value="American Samoa">American Samoa</option><option value="Andorra">Andorra</option><option value="Angola">Angola</option><option value="Anguilla">Anguilla</option><option value="Antarctica">Antarctica</option><option value="Antigua & Barbuda">Antigua & Barbuda</option><option value="Argentina">Argentina</option><option value="Armenia">Armenia</option><option 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value="Eritrea">Eritrea</option><option value="Estonia">Estonia</option><option value="Eswatini">Eswatini</option><option value="Ethiopia">Ethiopia</option><option value="Falkland Islands">Falkland Islands</option><option value="Faroe Islands">Faroe Islands</option><option value="Fiji">Fiji</option><option value="Finland">Finland</option><option value="France">France</option><option value="French Guiana">French Guiana</option><option value="French Polynesia">French Polynesia</option><option value="French Southern Territories">French Southern Territories</option><option value="Gabon">Gabon</option><option value="Gambia">Gambia</option><option value="Georgia">Georgia</option><option value="Germany">Germany</option><option value="Ghana">Ghana</option><option value="Gibraltar">Gibraltar</option><option value="Greece">Greece</option><option value="Greenland">Greenland</option><option value="Grenada">Grenada</option><option value="Guadeloupe">Guadeloupe</option><option value="Guam">Guam</option><option value="Guatemala">Guatemala</option><option value="Guernsey">Guernsey</option><option value="Guinea">Guinea</option><option value="Guinea-Bissau">Guinea-Bissau</option><option value="Guyana">Guyana</option><option value="Haiti">Haiti</option><option value="Heard & McDonald Islands">Heard & McDonald Islands</option><option value="Honduras">Honduras</option><option value="Hong Kong SAR China">Hong Kong SAR China</option><option value="Hungary">Hungary</option><option value="Iceland">Iceland</option><option value="India">India</option><option value="Indonesia">Indonesia</option><option value="Iran">Iran</option><option value="Iraq">Iraq</option><option value="Ireland">Ireland</option><option value="Isle of Man">Isle of Man</option><option value="Israel">Israel</option><option value="Italy">Italy</option><option value="Jamaica">Jamaica</option><option value="Japan">Japan</option><option value="Jersey">Jersey</option><option value="Jordan">Jordan</option><option value="Kazakhstan">Kazakhstan</option><option value="Kenya">Kenya</option><option value="Kiribati">Kiribati</option><option value="Kosovo">Kosovo</option><option value="Kuwait">Kuwait</option><option value="Kyrgyzstan">Kyrgyzstan</option><option value="Laos">Laos</option><option value="Latvia">Latvia</option><option value="Lebanon">Lebanon</option><option value="Lesotho">Lesotho</option><option value="Liberia">Liberia</option><option value="Libya">Libya</option><option value="Liechtenstein">Liechtenstein</option><option value="Lithuania">Lithuania</option><option value="Luxembourg">Luxembourg</option><option value="Macao SAR China">Macao SAR China</option><option value="Madagascar">Madagascar</option><option value="Malawi">Malawi</option><option value="Malaysia">Malaysia</option><option value="Maldives">Maldives</option><option value="Mali">Mali</option><option value="Malta">Malta</option><option value="Marshall Islands">Marshall Islands</option><option value="Martinique">Martinique</option><option value="Mauritania">Mauritania</option><option value="Mauritius">Mauritius</option><option value="Mayotte">Mayotte</option><option value="Mexico">Mexico</option><option value="Micronesia">Micronesia</option><option value="Moldova">Moldova</option><option value="Monaco">Monaco</option><option value="Mongolia">Mongolia</option><option value="Montenegro">Montenegro</option><option value="Montserrat">Montserrat</option><option value="Morocco">Morocco</option><option value="Mozambique">Mozambique</option><option value="Myanmar (Burma)">Myanmar (Burma)</option><option value="Namibia">Namibia</option><option value="Nauru">Nauru</option><option value="Nepal">Nepal</option><option value="Netherlands">Netherlands</option><option value="Netherlands Antilles">Netherlands Antilles</option><option value="New Caledonia">New Caledonia</option><option value="New Zealand">New Zealand</option><option value="Nicaragua">Nicaragua</option><option value="Niger">Niger</option><option value="Nigeria">Nigeria</option><option value="Niue">Niue</option><option value="Norfolk Island">Norfolk Island</option><option value="Northern Mariana Islands">Northern Mariana Islands</option><option value="North Korea">North Korea</option><option value="North Macedonia">North Macedonia</option><option value="Norway">Norway</option><option value="Oman">Oman</option><option value="Outlying Oceania">Outlying Oceania</option><option value="Pakistan">Pakistan</option><option value="Palau">Palau</option><option value="Palestinian Territories">Palestinian Territories</option><option value="Panama">Panama</option><option value="Papua New Guinea">Papua New Guinea</option><option value="Paraguay">Paraguay</option><option value="Peru">Peru</option><option value="Philippines">Philippines</option><option value="Pitcairn Islands">Pitcairn Islands</option><option value="Poland">Poland</option><option value="Portugal">Portugal</option><option value="Puerto Rico">Puerto Rico</option><option value="Qatar">Qatar</option><option value="Romania">Romania</option><option value="Russia">Russia</option><option value="Rwanda">Rwanda</option><option value="Réunion">Réunion</option><option value="Samoa">Samoa</option><option value="San Marino">San Marino</option><option value="Sark">Sark</option><option value="Saudi Arabia">Saudi Arabia</option><option value="Senegal">Senegal</option><option value="Serbia">Serbia</option><option value="Seychelles">Seychelles</option><option value="Sierra Leone">Sierra Leone</option><option value="Singapore">Singapore</option><option value="Sint Maarten">Sint Maarten</option><option value="Slovakia">Slovakia</option><option value="Slovenia">Slovenia</option><option value="Solomon Islands">Solomon Islands</option><option value="Somalia">Somalia</option><option value="South Africa">South Africa</option><option value="South Georgia & South Sandwich Islands">South Georgia & South Sandwich Islands</option><option value="South Korea">South Korea</option><option value="South Sudan">South Sudan</option><option value="Spain">Spain</option><option value="Sri Lanka">Sri Lanka</option><option value="St. Barthélemy">St. Barthélemy</option><option value="St. Helena">St. Helena</option><option value="St. Kitts & Nevis">St. Kitts & Nevis</option><option value="St. Lucia">St. Lucia</option><option value="St. Martin">St. Martin</option><option value="St. Pierre & Miquelon">St. Pierre & Miquelon</option><option value="St. Vincent & Grenadines">St. Vincent & Grenadines</option><option value="Sudan">Sudan</option><option value="Suriname">Suriname</option><option value="Svalbard & Jan Mayen">Svalbard & Jan Mayen</option><option value="Sweden">Sweden</option><option value="Switzerland">Switzerland</option><option value="Syria">Syria</option><option value="São Tomé & Príncipe">São Tomé & Príncipe</option><option value="Taiwan">Taiwan</option><option value="Tajikistan">Tajikistan</option><option value="Tanzania">Tanzania</option><option value="Thailand">Thailand</option><option value="Timor-Leste">Timor-Leste</option><option value="Togo">Togo</option><option value="Tokelau">Tokelau</option><option value="Tonga">Tonga</option><option value="Trinidad & Tobago">Trinidad & Tobago</option><option value="Tristan da Cunha">Tristan da Cunha</option><option value="Tunisia">Tunisia</option><option value="Turkmenistan">Turkmenistan</option><option value="Turks & Caicos Islands">Turks & Caicos Islands</option><option value="Tuvalu">Tuvalu</option><option value="Türkiye">Türkiye</option><option value="U.S. Outlying Islands">U.S. Outlying Islands</option><option value="U.S. Virgin Islands">U.S. Virgin Islands</option><option value="Uganda">Uganda</option><option value="Ukraine">Ukraine</option><option value="United Arab Emirates">United Arab Emirates</option><option value="United Kingdom">United Kingdom</option><option value="United States">United States</option><option value="Uruguay">Uruguay</option><option value="Uzbekistan">Uzbekistan</option><option value="Vanuatu">Vanuatu</option><option value="Vatican City">Vatican City</option><option value="Venezuela">Venezuela</option><option value="Vietnam">Vietnam</option><option value="Wallis & Futuna">Wallis & Futuna</option><option value="Western Sahara">Western Sahara</option><option value="Yemen">Yemen</option><option value="Zambia">Zambia</option><option value="Zimbabwe">Zimbabwe</option><option value="Åland Islands">Åland Islands</option></select> </div> </div></div></div> <div class="js-form-item form-item js-form-type-select form-type-select js-form-item-interest form-item-interest"> <label for="edit-interest" class="js-form-required form-required">I am interested in</label> <select data-drupal-selector="edit-interest" id="edit-interest" name="interest" class="form-select required" required="required" aria-required="true"><option value="" selected="selected">- 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block block-views block-views-blockgroup-header-block-1" id="block-views-block-group-header-block-1"> <div><div class="view view-group-header view-id-group_header view-display-id-block_1 js-view-dom-id-1118670e82d24601fd0a8ce4cfa00673a617019da66cb6956e0e0d4676c115c5"> <div class="view-content"> <div class="views-row"><div class="views-field views-field-field-media-image-3-1"><div class="field-content"><div class="node-header"> <div class="node-header-image" data-node-header-image="/sites/default/files/hero-image/pharma-default-header-bg-img.jpg"> <div class="node-header-tab"></div> </div> <div class="node-header-content"> <div class="node-header-wrap"> <h1 class="page-title">Project Requirements and Compliance</h1> <span class="blue-bar bar-large"></span> <div class="page-subtitle"></div> </div> </div> </div></div></div></div> </div> </div> </div> </div> <div class="views-element-container block block-views block-views-blockdefault-header-block-1" 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class="layout-content"> <a id="main-content" tabindex="-1"></a> <div class="region region-content"> <div data-drupal-messages-fallback class="hidden"></div> <div id="block-neogenomics-content" class="block block-system block-system-main-block"> <article data-history-node-id="1146" class="node node--type-page node--view-mode-full"> <div class="node__content"> <div class="field field--name-field-section field--type-entity-reference-revisions field--label-hidden field__items"> <div class="paragraph paragraph--type--columns paragraph--view-mode--default corporate-pattern-bg"> <div id="" class="col-half padding-top-bottom-50"> <div class="field field--name-field-column-content field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--wysiwyg paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p class="large">NeoGenomics Pharma Services project requirements and compliance information.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--wysiwyg paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>For general inquiries to NeoGenomics Pharma Services, you can contact us by email, phone, or directly on our website:</p> <p>E-mail: <a href="mailto:pharmaservices@neogenomics.com">pharmaservices@neogenomics.com</a><br> Phone: 800-720-4363 ext. 6419</p> <p>To send a general email to the Pharma Services team, please click the Contact Us button at the bottom of this page.</p> </div> </div> </div> </div> </div> </div> <div id="" class="paragraph paragraph--type--text-image-equal-height-columns paragraph--view-mode--default"> <div class="equal-height-image-section img-right"> <div class="equal-height-image-content"> <div id="paragraph-id-953" class="media-wrap lazyload-bg" style=";background-image: url('/sites/default/files/styles/lazy_load/public/2021-07/GettyImages-1128200464.jpg?itok=VHN4SVaD');" data-lazyload="/sites/default/files/2021-07/GettyImages-1128200464.jpg"></div> <div class="content-wrap" style=""> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><h3><strong>When contacting us, please be as specific as you can on the following:</strong></h3> <ul> <li><strong>Type of the project</strong> - Biomarker Discovery, Translational Research, Assay Design & Development, Clinical Trial Testing, FDA Filing, Launch Preparation, Commercialization</li> <li><strong>Test modality of interest</strong> - Anatomic Pathology, Molecular, Multiplexed Immunofluorescence, Flow Cytometry, FISH and Cytogenetics</li> <li><strong>Target timeline</strong></li> <li><strong>Quality and regulatory requirement</strong></li> </ul> </div> </div> </div> </div> </div> <div id="" class="paragraph paragraph--type--wysiwyg-full-width paragraph--view-mode--default corporate-pattern-bg"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><h2>Diagnostic Quality Management Systems Information</h2> <p>NeoGenomics Laboratories, Inc. is fully licensed under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”) as well as accredited by the College of American Pathologists.</p> <p>In addition, NeoGenomics maintains all necessary licenses required by all states in which it provides services, including but not limited to the States of New York and California.</p> <p>NeoGenomics is committed to providing its services with the highest level quality and patient safety. This commitment is evident through our Quality Management System (“QMS”) which includes the following key elements:</p> <ul class="newspaper-col-2"> <li><strong>Quality Expertise</strong>: We have dedicated department of quality professionals who manage and administer key elements of our QMS, such as licensure & credentialing, proficiency testing, document control and training & competency.</li> <li><strong>Test Performance</strong>: All tests are developed and validated in full compliance with all federal, state and local laws, rules and regulations, including CLIA, New York State and CAP standards. Test performance is routinely and closely monitored to ensure the timely delivery of accurate test results to our clients and their patients.</li> <li><strong>Staff Competency</strong>: All NeoGenomics' clinical laboratory personnel are required to have all appropriate credentials and experience to perform the tests provided by NeoGenomics. In addition, all NeoGenomics' personnel are required to participate in continual training and competency programs to ensure that each employee remains proficient and qualified to perform all testing with optimal expertise.</li> <li><strong>Process Improvement</strong>: NeoGenomics adheres to Lean and Six Sigma processes to ensure its continued excellence in services and reduce obstacles throughout in our process.</li> </ul> </div> </div> <div id="" class="paragraph paragraph--type--wysiwyg-full-width paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p class="large">Enterprise LIMS System and Pharma Services Client Portal</p> <p>NeoGenomics Pharma Services employs LabVantage Enterprise LIMS system to support workflows at our global laboratories and Pharma Services Client Portal (PSP) to provide seamless client interfacing with controlled and secure real-time access. The two systems are integrated, validated, and meet 21 CFR Part 11 requirements. </p> <table style="width:100%;" border="0" cellpadding="1" cellspacing="1"> <thead> <tr> <th scope="col">Neo LabVantage Enterprise LIMS</th> <th scope="col">Pharma Services Client Portal (PSP)</th> </tr> </thead> <tbody> <tr> <td> <ul> <li>Internal enterprise system for our global laboratories</li> <li>End-to-end solution from study set-up & accessioning to reporting results <ul> <li>Reagent management</li> <li>Instrument integration</li> <li>Sample management & traceability</li> <li>Custom test codes and reporting support</li> </ul> </li> <li>Security & Auditing</li> <li>Data management & retrieval</li> </ul> </td> <td> <ul> <li>Dedicated client portal with controlled access at project, site, or sponsor level</li> <li>Dashboard organization at the sponsor & project level</li> <li>Worklist includes accession data, images, instrument files, requisitions, and ancillary information</li> <li>Inventory Tracking</li> <li>Online Ordering</li> <li>Project/study data access and sharing</li> <li>Secured FTP transfer</li> <li>Multilingual: English, German, French, Spanish, Chinese, Russian</li> </ul> </td> </tr> </tbody> </table> <p> </p> </div> </div> <div id="" class="paragraph paragraph--type--wysiwyg-full-width paragraph--view-mode--default corporate-pattern-bg"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><h3>Project Management or Project Support Inquiries</h3> <p>We have dedicated NeoGenomics project managers for each client project. For Project Management inquiries on your project, please contact your NeoGenomics project manager directly.</p> <p>For Project Support inquiries, please contact your NeoGenomics project manager directly or email our Project Support Team at: <a href="mailto:Pharma_Project_Support_Team@neogenomics.com">Pharma_Project_Support_Team@neogenomics.com</a>.</p> <h3>Shipping Specimen to NeoGenomics Pharma Services</h3> <p>For shipping specimens to NeoGenomics for your project, please check the following specimen input and requirements guidelines. If you have custom requirements, please contact your NeoGenomics project manager directly. And please check with your NeoGenomics representative before shipping to ensure delivery to the appropriate location of our global labs.</p> </div> </div> <div class="paragraph paragraph--type--resources paragraph--view-mode--default"> <h4 class="resources-title">Specimen Requirements and Guidelines</h4> <div class="field field--name-field-links field--type-link field--label-hidden field__items"> <div class="field__item"> <a href="/sites/default/files/2021-07/pharma-services-specimen-requirements.pdf" tabindex="0" target="_blank"> General Specimen Requirements & Handling Guide </a> </div> <div class="field__item"> <a href="/sites/default/files/2021-07/Pharma-Molecular-Specimen-Prep-07182021.pdf" tabindex="0" target="_blank"> Molecular Specimen Input & Requirements Guide </a> </div> </div> </div> <div id="" class="paragraph paragraph--type--wysiwyg-full-width paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><h3>Shipping Information - addresses and contact information for our global labs</h3> <table style="width:100%;" border="0" cellpadding="1" cellspacing="1"> <tbody> <tr> <td>NeoGenomics Laboratories, Inc. <br>Attn: Pharma Services Department <br>31 Columbia <br>Aliso Viejo, CA 92656 <br>United States <br>Phone: +1-949-445-7300 X7103 <br>Email: <a href="mailto:Pharma_Project_Support_Team@neogenomics.com">Pharma_Project_Support_Team@neogenomics.com</a> <br>Shipment Acceptance: Monday - Saturday</td> <td>NeoGenomics Laboratories, Inc. <br>Attn: Pharma Services Department <br>4570 Executive Drive, Suite 250 <br>San Diego, CA 92121 <br>United States <br>Phone: +1-949-445-7300 ext. 5043 <br>Email: <a href="mailto:LJ_Pharma_Services@neogenomics.com">LJ_Pharma_Services@neogenomics.com</a> <br>Shipment Acceptance: Monday - Saturday</td> </tr> <tr> <td>NeoGenomics Laboratories, Inc. <br>Attn: Pharma Services Department <br>9490 NeoGenomics Way <br>Fort Myers, FL 33912 <br>United States <br>Phone: +1-239-768-0600 <br>Email: <a href="mailto:FortMyers_Pharmaprocessing@neogenomics.com">FortMyers_Pharmaprocessing@neogenomics.com</a> <br>Shipment Acceptance: Monday - Saturday</td> <td>NeoGenomics Laboratories, Inc. <br>Attn: Pharma Services Department <br>7256 South Sam Houston Parkway West, Suite 300 <br>Houston, TX 77085 <br>United States <br>Phone: +1-713-830-6421 <br>Email: <a href="mailto:HoustonPharmaTeam@neogenomics.com">HoustonPharmaTeam@neogenomics.com</a> <br>Shipment Acceptance: Monday - Friday</td> </tr> <tr> <td>NeoGenomics Laboratories, Inc.<br>Attn: Accessioning Department<br>8 Davis Drive, Suite 120<br>Durham, NC 27709<br>United States<br>Phone: +1-919-884-6480<br>Email: <a href="mailto:inv-accessioning@neogenomics.com">inv-accessioning@neogenomics.com</a><br>Shipment Acceptance: Monday - Saturday</td> <td>NeoGenomics - Inivata Ltd.<br>Glenn Berge Building<br>Babraham Research Campus<br>Cambridge, CB22 3FH<br>United Kingdom<br>Phone: +44 (0) 1223 790 880<br>Email: <a href="mailto:inv-uklabteam@neogenomics.com">inv-uklabteam@neogenomics.com</a><br>Shipment Acceptance: Monday - Saturday</td> </tr> </tbody> </table> <p> </p> </div> </div> <div class="paragraph paragraph--type--block-reference paragraph--view-mode--default"> <div class="field field--name-field-block-reference field--type-block-field field--label-hidden field__item"><div id="block-genericcontactcta" class="block block-block-content block-block-content8a55c531-c994-47e1-876c-0677143882c7 block--full-width-cta"> <div class="cta-content-wrap"> <div class="cta-content"> <h4 class="field--name-field-title">Contact Us To Get Started!</h4> <p class="field--name-field-body-unformatted">Work with us – your premier oncology partner – to optimize cancer care for patients</p> <div class="field--name-field-link"> <a href="/contact-us" class="small-upper" > Learn More </a> </div> </div> </div> </div> </div> </div> </div> </div> </article> </div> </div> </div> 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