Project Requirements and Compliance

NeoGenomics Pharma Services project requirements and compliance information.

For general inquiries to NeoGenomics Pharma Services, you can contact us by email, phone, or directly on our website:

E-mail: pharmasalesops@neogenoimics.com
Phone: 800-720-4363 ext. 6419

To send a general email to the Pharma Services team, please click the Contact Us button at the bottom of this page.

When contacting us, please be as specific as you can on the following:

  • Type of the project - Biomarker Discovery, Translational Research, Assay Design & Development, Clinical Trial Testing, FDA Filing, Launch Preparation, Commercialization
  • Test modality of interest - Anatomic Pathology, Molecular, Multiplexed Immunofluorescence, Flow Cytometry, Immunoassay, FISH and Cytogenetics
  • Target timeline
  • Quality and regulatory requirement

Diagnostic Quality Management Systems Information

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.

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.

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:

  • Quality Expertise: 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.
  • Test Performance: 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.
  • Staff Competency: 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.
  • Process Improvement: NeoGenomics adheres to Lean and Six Sigma processes to ensure its continued excellence in services and reduce obstacles throughout in our process.

Enterprise LIMS System and Pharma Services Client Portal

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. 

Neo LabVantage Enterprise LIMS Pharma Services Client Portal (PSP)
  • Internal enterprise system for our global laboratories
  • End-to-end solution from study set-up & accessioning to reporting results
    • Reagent management
    • Instrument integration
    • Sample management & traceability
    • Custom test codes and reporting support
  • Security & Auditing
  • Data management & retrieval
  • Dedicated client portal with controlled access at project, site, or sponsor level
  • Dashboard organization at the sponsor & project level
  • Worklist includes accession data, images, instrument files, requisitions, and ancillary information
  • Inventory Tracking
  • Online Ordering
  • Project/study data access and sharing
  • Secured FTP transfer
  • Multilingual: English, German, French, Spanish, Chinese, Russian

 

Project Management or Project Support Inquiries

We have dedicated NeoGenomics project managers for each client project. For Project Management inquiries on your project, please contact your NeoGenomics project manager directly.

For Project Support inquiries, please contact your NeoGenomics project manager directly or email our Project Support Team at: Pharma_Project_Support_Team@neogenomics.com.

Shipping Specimen to NeoGenomics Pharma Services

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.

Shipping Information - addresses and contact information for our global labs

NeoGenomics Laboratories, Inc.
Attn: Pharma Services Department
31 Columbia
Aliso Viejo, CA 92656
United States
Phone: +1-949-445-7300 X7103
Email: Pharma_Project_Support_Team@neogenomics.com
Shipment Acceptance: Monday - Saturday
NeoGenomics Laboratories, SA
Attn: Pharma Services Department
A-One Business Center Z.A.
La Pièce/Route de l’Etraz 1
Bâtiment A5, 2nd Floor
Rolle 1180
Switzerland
Phone: +41.21.721.06.00 x4110
Email: rolle.pharmaprocessing@neogenomics.com.
Shipment Acceptance: Monday - Sunday
NeoGenomics Singapore PTE LTD.
Attn: Pharma Services Department
61 Science Park Road
02-11
The Galen
Singapore 117525 Phone: +65-69115202/5201
Email: Project_Support_SG_SM@neogenomics.com
Shipment Acceptance: Monday - Saturday
NeoGenomics Laboratories, Inc.
Attn: Pharma Services Department
4570 Executive Drive, Suite 250
San Diego, CA 92121
United States
Phone: +1-949-445-7300 ext. 5043
Email: LJ_Pharma_Services@neogenomics.com
Shipment Acceptance: Monday - Saturday
NeoGenomics Laboratories, Inc.
Attn: Accessioning
2110 Rutherford Rd.
Carlsbad, CA 92008
United States
Phone: +1-858-431-9126
Email: lauren.cardone@neogenomics.com
Shipment Acceptance: Monday - Saturday
NeoGenomics Laboratories, Inc.
Attn: Pharma Services Department
7256 South Sam Houston Parkway West, Suite 300
Houston, TX 77085
United States
Phone: +1-713-830-6421
Email: HoustonPharmaTeam@neogenomics.com
Shipment Acceptance: Monday - Friday
NeoGenomics Laboratories, Inc.
Attn: Pharma Services Department
12701 Commonwealth Dr., Suite 5
Fort Myers, FL 33913
United States
Phone: +1-239-768-0600
Email: FortMyers_Pharmaprocessing@neogenomics.com
Shipment Acceptance: Monday - Saturday
Suzhou Neogenomics Pharmaceutical Research Co. Ltd.
Attn: Weiwei Zhao
Building 6, Block 19, Yong'an Road; Xuguan Industrial Park
Suzhou New district
Suzhou, Jiangsu
PR China

 

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