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Digital Pathology Making Inroads Around The World
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Diagnostics World News | Pathologists around the world over—65,000 of them in 163 countries at last count—appear enamored of a free and easy-to-use digital pathology platform that allows slides to be aggregated irrespective of the scanner that created them.

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Young Scientists Present Diagnostic Solutions At Molecular Medicine Tri-Conference
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Diagnostics World News | During the Molecular Medicine Tri-Conference, dozens of early-career scientists presented their solutions to real-world clinical, scientific, and organizational problems at the event's poster viewing sessions.

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Point-Of-Care Testing And Diagnostics In Vietnam
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Diagnostics World News | At the Molecular Medicine Tri-Conference in San Francisco, Gerald Kost gave insight into point-of-care testing's impact in Central Vietnam.

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Variant Interpretation Then And Now: Moving Toward Rigorous, Consistent Workflows
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Diagnostics World Contributed Commentary | Variant interpretation has come a long way since the days when single-gene or even single-variant tests represented the cutting edge in clinical labs. With the explosion of next-generation sequencing (NGS) and other multiplex-friendly technologies, variant analysts who could once easily perform manual review of every mutation, now face an onslaught of data.

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ASHG Issues Position Statement On Recontact For Genetic Results
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Diagnostics World News Brief | The American Society of Human Genetics, along with several co-signing organizations, issued a position statement today outlining whether, and to what extent, there is a responsibility to recontact genetic and genomic research participants.

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Bill Gates, Jeff Bezos Donate Millions To Alzheimer's Research
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Diagnostics World News Brief | The Bill and Melinda Gates Foundation and the Day One Fund, launched by Amazon CEO Jeff Bezos, have teamed up to donate $15 million to the Alzheimer's Drug Discovery Foundation (ADDF) in support of its Diagnostics Accelerator research program. This latest donation brings the total program funding to $50 million since its launch in July 2018.

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From Nobel Prize-Worthy To Quaint: PCR’s Past, Present, And Predicted Future
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Diagnostics World News | Imagine a future in which polymerase chain reaction (PCR) is viewed as old-fashioned. In the meantime, researchers generate billions of copies of the sequence of interest in order to carry out experiments and procedures in fields like molecular biology, evolutionary biology, and medical diagnostics.

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MinION Could Reduce Huntington's Disease Diagnosis To Days Instead Of Weeks
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Diagnostics World News Brief | The world's first genetic test for Huntington's disease using nanopore-based DNA sequencing technology is now available at Guy's and St Thomas' NHS Foundation Trust.

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Vela, Ortho, UC Berkley, And More: News From March 2019
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Diagnostics World News | March featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Vela, Ortho, UC Berkley, and more.

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Harnessing Machine Learning And Artificial Intelligence To Accelerate Discovery In Diagnostics
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Diagnostics World News | As several diagnostics advances have found their footing in AI, researchers have been able to churn out massive amounts of data. However, results have revealed challenges in scaling up analysis. At the Molecular Medicine Tri-Conference in San Francisco, a multidisciplinary cadre of thought leaders tackled this issue, sharing their latest applications of these technologies to large-scale data to streamline diagnostics.

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Certara Adds Four Global Leaders to its Simcyp® PBPK, QSP and QSTS Modeling and Simulation Division
| PRINCETON, NJ - Apr 17, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced four senior executive appointments in its Simcyp division more

WCG Expands its Research Site Executive Team, Global Research Network
| PRINCETON, NJ - Apr 12, 2019 - The WIRB-Copernicus Group® (WCG™) is pleased to announce the addition of several prominent executives to its Site Division and the expansion of its Global Research Network™ (GRN) of investigative sites more

WCG Announces the Acquisition of Analgesic Solutions, LLC
| PRINCETON, NJ - Apr 4, 2019 - The WIRB-Copernicus Group®’s (WCG™) Clinical Services Division announces the acquisition of Analgesic Solutions, LLC, the global leader in the development of new pain medications and in the support of clinical trials in which pain is an indicator of an underlying condition more

BINDING SITE OFFERS NATIVE BORDETELLA PERTUSSIS ANTIGENS
| SAN DIEGO, CA - Apr 3, 2019 - ~~BINDING SITE’s IMMUNOLOGICALS GROUP is pleased to announce the addition of three (3) new native Bordetella pertussis antigens to its broad offering of products for in-vitro diagnostic (IVD) manufacturing and research applications more

OncoCell Announces Late-Breaking Poster Presentation at AACR 2019 on a Noninvasive Blood-Based Assay for Prostate Cancer Prognosis
| ATLANTA, GA, UNITED STATES - Apr 1, 2019 - April 1, 2019 - ATLANTA - OncoCell MDx, a company developing novel noninvasive diagnostic and prognostic tests, will present results from a feasibility study of a new prostate cancer prognostic assay in a late-breaking poster session at the American Association of Cancer Research (AACR) Annual Meeting tomorrow more

BioIVT Joins the Foundation for the National Institutes of Health Biomarkers Consortium
| WESTBURY, NY - Mar 25, 2019 - BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium more

WCG Introduces a Transformational Solution for Clinical Research Sites
| PRINCETON, NJ - Mar 19, 2019 - WIRB-Copernicus Group® (WCG™) introduces WCG SiteReady™, a first-of-its-kind solution aimed at increasing the efficiency and profitability of clinical research for institutions and independent research sites more

BioIVT Webinar to Discuss Ethical and Regulatory Issues Regarding Use of Human Biospecimens in Life Sciences Research in the UK and EU
| WESTBURY, NY - Mar 18, 2019 - BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it will be co-hosting a one-hour webinar entitled “Gaining Clarity: Unique Considerations for the Ethical and Regulatory Use of Human Biospecimens in the European Union (EU) and United Kingdom (UK)” at 8 a more

Precision BioLogic’s CRYOcheck™ Factor VIII Inhibitor Kit Cleared for Sale in U.S.
| HALIFAX, NS, CANADA - Mar 13, 2019 - Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of its CRYOcheck Factor VIII Inhibitor Kit in the U more

Certara Scientists Advance ASCPT Agenda: From Molecule to Patient
| PRINCETON, NJ - Mar 13, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 Annual Meeting more

Cadex Genomics Announces Pivotal Cancer Therapy Non-Response Monitoring Study with Rocky Mountain Cancer Centers
| REDWOOD CITY, CA, UNITED STATES - Mar 12, 2019 - Cadex Genomics, Corp. announced that it has initiated a pivotal clinical study designed to validate the ability of Alibrex to act as a biomarker for predicting early non-response to therapy in stage IV cancer patients more

Rehabilitation Technology Expert Signs Letter of Intent to Employ Shimmer’s Verisense™ Continuous Monitoring Platform in New Clinical Trial
| CAMBRIDGE, MA - Mar 11, 2019 - Shimmer, a global leader in wearable technology for research applications, announced that Paolo Bonato, PhD, director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital in Boston, has signed a letter of intent to employ Shimmer’s Verisense continuous monitoring platform during his next clinical trial to study motor recovery in stroke survivors more

New TB blood test enters clinical trials
| LEICESTER, UK - Mar 6, 2019 - A new blood test for tuberculosis (TB) could, for the first time, enable screening of patients at an early stage of infection more

BioIVT Launches Its XPRESSWAY® Profile Safety Package, a Gene Expression Reference Guide Designed to Improve Drug Safety Analyses
| WESTBURY, NY - Mar 6, 2019 - BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the launch of its XPRESSWAY Profile Safety Package, a compendium of 46 gene expression profiles for genes known to play pivotal roles in drug safety assessments more

Menarini Silicon Biosystems Develops New Assay Workflow for Circulating Multiple Myeloma Cells
| HUNTINGDON VALLEY, PA, UNITED STATES - Mar 5, 2019 -   Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, announced today that it will introduce a new semi-automated assay workflow utilizing the CELLSEARCH® and DEPArrayTM platforms to enumerate and characterize circulating multiple myeloma cells (CMMC) from peripheral blood samples more

Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems
| PRINCETON, NJ - Mar 5, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that the US Centers for Disease Control & Prevention (CDC) has awarded it a contract to strengthen the Agency’s death investigation and surveillance systems more

MR Solutions’ high-field multi-modality, cryogen-free MRI system on display at EMIM
| GUILDFORD, UNITED KINGDOM - Feb 27, 2019 - MR Solutions’ latest compact preclinical, multi-modality MRI systems will be on display at the 14th European Molecular Imaging Meeting (EMIM 2019) being held at the Scottish Event Campus in Glasgow on 19 to 22 March, 2019 more

AlloSure now available for Lung Transplant Patients
| LOS ANGELES, CA, UNITED STATES - Feb 21, 2019 - https://globenewswire.com/news-release/2019/02/21/1739290/0/en/AlloSure-now-available-for-Lung-Transplant-Patients more

Certara Launches Version 19.1 of its D360 Scientific Informatics Platform
| PRINCETON, NJ - Feb 21, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the launch of version 19 more

SAW Diagnostics Receives £1.5M Innovate UK Funding to Support Commercialisation of its Point of Care Diagnostics Technology Platform
| GLASGOW, UK - Feb 12, 2019 - SAW Diagnostics Limited (SAW Dx), an emerging biological sample analysis and point of care diagnostic company, announced today that Innovate UK, the UK’s innovation Agency, has awarded the company a £1 more

Shimmer Launches Verisense™ Wearable Sensor Platform for Clinical Trials
| CAMBRIDGE, MA, US - Feb 19, 2019 - Shimmer, a global leader in wearable technology for research applications, today announced the launch of Verisense, its next-generation wearable sensor platform designed from the ground up to meet the needs of clinical trial sponsors, sites and participants more

Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response
| HERCULES, CA - Feb 14, 2019 - (BUSINESS WIRE) - Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the industry’s first digital PCR products to receive U more

Sysmex America UN-2000TM Now Available in U.S. and Canada
| CHICAGO, IL, UNITED STATES - Feb 10, 2019 - Sysmex America, Inc., a leading diagnostic solutions company offering hematology, urinalysis and flow cytometry testing technology that improves clinical laboratory performance, announced the availability of its first fully automated urine particle counter and digital imaging system, the UN-2000 more

Certara Advances Global Initiative to Take Model-informed Precision Dosing (MIPD) Into the Clinic
| PRINCETON, NJ - Feb 7, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced its latest advances in bringing model-informed precision dosing (MIPD) to the point of care more

Clinithink secures growth-equity investment to fuel growth
| LONDON, UNITED KINGDOM - Feb 7, 2019 - Leading healthcare technology investors partner with Clinithink to unlock the potential of unstructured data to inform treatment decisions, identify candidates for clinical trials, and ensure appropriate reimbursement  Clinithink, which offers healthcare and life sciences organizations powerful clinical data insights through its patented CLiX natural language processing (NLP) platform, has secured a growth-equity investment from TT Capital Partners (TTCP)  and the MSD Global Health Innovation Fund (GHI) to expand its global footprint and continue to broaden its service offering more

WCG Acquires First Clinical Research, LLC
| PRINCETON, NJ - Jan 30, 2019 - The WIRB-Copernicus Group®’s (WCG™) Market Intelligence & Insights Division has acquired First Clinical Research LLC, organizer of the MAGI (Model Agreements & Guidelines International) Clinical Research Conference, which unifies the clinical research ecosystem by facilitating communication and the sharing of best practices among members more

Certara Launches Version 18 of its Physiologically-based Pharmacokinetic (PBPK) Simcyp Simulator
| PRINCETON, NJ - Jan 29, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the launch of version 18 of its Simcyp® Population-based Simulator more

CAMBRIDGE DIAGNOSTIC INNOVATION SET FOR GLOBAL IMPACT ON LUNG CANCER SCREENING
| CAMBRIDGE, UK - Jan 18, 2019 - ~~Rapid Biosensor Systems (RBS), the technology company that developed a 2-minute breathalyser test for TB, can adapt its platform technology for screening of lung cancer more

Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Fourth Consecutive Year
| PRINCETON, NJ - Jan 15, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2018 were supported by Certara software or services more

Multiple Publications and Presentations Underscore Seno Medical's Value Proposition in Mitigating the Cost and Burden of Unnecessary Breast Biopsies
| SAN ANTONIO, TX, UNITED STATES - Jan 8, 2019 - SAN ANTONIO, Jan. 8, 2019 /PRNewswire/ -- Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses, today provided a summary of key 2018 data publications and presentations that demonstrate the clinical utility and healthcare economic benefits of its proprietary, cutting-edge technology more

New Data on AlloSure Confirms Its Clinical Utility in Repeat Kidney Transplant Recipients
| BRISBANE, CA, UNITED STATES - Dec 20, 2018 - BRISBANE, Calif., Dec. 20, 2018 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announces the publication of data demonstrating the clinical utility of measuring AlloSure in repeat kidney transplant recipients in the  American Journal of Transplantation more

WATS3D Markedly Improves Detection of Esophageal Dysplasia and Barrett’s Esophagus in 12,899 Patient Study in the “Real World” Practice setting of 58 Community-Based Gastroenterologists
| SUFFERN, NY, UNITED STATES - Dec 20, 2018 - SUFFERN, N.Y., Dec. 20, 2018 (GLOBE NEWSWIRE) -- CDx Diagnostics today announced the publication of new data demonstrating that the addition of WATS3D (Wide Area Transepithelial Sampling with 3D Tissue Analysis) to standard targeted and random forceps biopsy (FB) markedly increases the overall detection of esophageal dysplasia (ED) by 242% and the overall detection of Barrett’s esophagus (BE) by 153% in patients undergoing BE screening and surveillance more

Certara Publishes New Report Investigating Success Factors for Outcomes-based Contracting, Giving Guidelines to Pharma and Payers
| PRINCETON, NJ - Dec 19, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced a new research report that investigates the potential of pharmaceutical outcomes-based contracting more

SINGULEX RECEIVES NEW, BROAD PATENT FOR HIGHLY SENSITIVE METHODS FOR ANALYSIS OF TROPONIN
| ALAMEDA, CA, UNITED STATES OF AMERICA - Dec 17, 2018 - Contact: Marcia Ruggio
Global Brand Marketing Manager
m.ruggio@singulex.com 
(510) 995-3859Singulex, Inc more

QuantuMDx Group Limited and Molbio Diagnostics announce a Memorandum of Understanding
| , UK & INDIA - Dec 12, 2018 - QuantuMDx Group Limited and Molbio Diagnostics Private Limited have signed a memorandum of understanding (MoU) to explore opportunities for joint working in infectious disease diagnostics, with an initial focus on genotypic drug resistance testing for those infected with tuberculosis more

AusDiagnostics has CE marked a new kit for detection of haemochromatosis
| SYDNEY, AUSTRALIA - Dec 10, 2018 - AusDiagnostics has CE marked a new kit for detection of haemochromatosis - a genetic disease that results in iron overload and eventually organ failure more

New Clinical Data Further Validate SAVI SCOUT® Radar Localization System for Simpler, Positive Axillary Lymph Node Localization
| SAN ANTONIO, TX, UNITED STATES - Dec 7, 2018 - SAN ANTONIO, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Data presented this week on wire-free radar breast localization demonstrated it may be a practical approach for positive axillary lymph node localization prior to neoadjuvant chemotherapy treatment (NAT) response more

Certara Launches BaseCase Toolkits to Facilitate Pharmaceutical and Medical Device Field Teams’ HCP and Payer Presentations
| PRINCETON, NJ - Dec 5, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced the launch of its BaseCase Toolkits, an add-on to BaseCase Interactive which helps pharmaceutical and medical device field representatives better manage and utilize their resources for use during customer presentations more

At AES 2018 Cognizance Biomarkers Unveils Data Showing It Can Accurately Distinguish between Epileptic and Psychogenic Nonepileptic Seizures
| SPRING HOUSE, PA, UNITED STATES - Dec 3, 2018 - Cognizance Biomarkers, LLC, a wholly-owned subsidiary of Evogen, Inc., a leader in proteomic and genomic-based testing for improved diagnosis and treatment of neurological disorders, today reported that a study1 being presented at the 2018 Annual Meeting of the American Epilepsy Society (AES) shows its blood-based neuroinflammatory biomarker test and algorithm can accurately distinguish epileptic seizures (ES) from psychogenic nonepileptic seizures (PNES) more

Certara Launches Trial Simulator 2.3 to Improve Clinical Trial Success
| PRINCETON, NJ - Nov 28, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced the launch of version 2 more

Check4Cancer launches innovative prostate cancer diagnosis pathway with AXA PPP healthcare
| CAMBRIDGE, UK - Nov 27, 2018 - Prostate cancer is the most common cancer in men, with 1 in 8 diagnosed at some point in their lives more

VIB Accelerates Therapeutic Biologics Discovery with Geneious Biologics
| AUCKLAND CITY, NEW ZEALAND - Nov 15, 2018 - VIB Accelerates Therapeutic Biologics Discovery with Geneious Biologics

AUCKLAND, NZ - November 12, 2018 - Geneious Biologics, an enterprise software solution for companies engaged in screening of antibodies and antibody-like molecules, has been chosen by the VIB (a Life Sciences Research Institute in Belgium) to support therapeutic biologics discovery at its Discovery Sciences group more

CareDx Announces Pricing of Public Offering of Common Stock
| BRISBANE, CA - Nov 14, 2018 - CareDx Announces Pricing of Public Offering of Common StockBRISBANE, Calif., Nov. 13, 2018 (GLOBE NEWSWIRE) -- CareDx, Inc more

US FDA Awards Certara’s Simcyp Division Two New Dermal Virtual Bioequivalence Grants
| PRINCETON, NJ - Nov 14, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced that it has been awarded two new dermal virtual bioequivalence grants by the US Food and Drug Administration (FDA) more

MR Solutions shows new state-of-the-art bench top CT preclinical scanner with clip on PET and SPECT at nuclear medicine congress
| GUILDFORD, UNITED KINGDOM - Nov 9, 2018 - MR Solutions continues to expand its range of preclinical scanners with the first showing of its elegant bench top CT scanner more

Certara’s Evidence, Value & Access Specialists to Host Symposium on Automation in Public Health Decision-making and Present 18 Posters at ISPOR Europe
| PRINCETON, NJ - Nov 8, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced that its Evidence, Value & Access team will host an educational symposium and present 18 research posters at ISPOR Europe 2018 more

International Biomedical Research Alliance Appoints J&J Development Corporation President to its Board of Directors
| BETHESDA, MD - Nov 6, 2018 - The International Biomedical Research Alliance, a non-profit organization which provides programming and funding support for the National Institutes of Health (NIH) Oxford-Cambridge Scholars Program, today announced that Tom Heyman is joining the Alliance’s board of directors more

Wision AI Applies Expertise in Machine-Learning and Mathematical Medicine to Improve Polyp Detection
| LOS ANGELES, CA, UNITED STATES - Nov 5, 2018 - SHANGHAI, China, Nov. 01, 2018 (GLOBE NEWSWIRE) -- Shanghai Wision AI
Co., Ltd, a leader in developing computer-aided diagnostic algorithms
and systems to improve the accuracy and effectiveness of diagnostic
imaging, today announced results of a study validating a novel
machine-learning algorithm that improves detection of adenomatous
polyps during colonoscopy more

BioIVT Acquires Biological Specialty Corporation, Adds Donor Centers and Increases Its Immune Cell Capacity
| WESTBURY, NY - Nov 5, 2018 - BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it has acquired Biological Specialty Corporation (BSC), a supplier of human blood products and components to the life sciences research community for more than 37 years more

Certara Scientists to Demonstrate Latest Modeling and Simulation Advances at AAPS PharmSci 360
| PRINCETON, NJ - Nov 1, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence solutions, today announced that its scientists will lead 15 sessions, and also host a Phoenix User Group Meeting, at the American Association of Pharmaceutical Scientists’ (AAPS) Annual Meeting – PharmSci 360 more



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