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  • About Us
    • Leadership
      • Louise M. Murphy, PhD, MBA, CQA
      • Brian G. Murphy, BEng, PhD
      • Steve O. Balyakin, MD, PhD, FFPM, CMC
    • Quality
    • Infrastructure
    • Strengths
    • News & Events
    • Privacy Policy
  • Services
    • Clinical Trial Project Management
    • Clinical Trial Investigator Meetings & Event Planning
    • Clinical Trial Monitoring
    • Clinical Trial Medical Monitor & Medical Safety
    • Clinical Trial Data Management
    • Clinical Trial Biostatistics
    • Medical Writing Services
    • Clinical Regulatory Affairs
    • Quality Assurance for Clinical Trials
    • Clinical Trials Consultant
      • Engineering
      • Data Management
      • Biostatistics Consulting
  • Therapeutic Areas
  • Medical Devices
  • Technology
    • Harnessing the Power of Oracle InForm with ClinDatrix
    • SAS
    • NQuery
    • IRT, IWRS
  • Global Affiliates
    • Venn Life Sciences
    • DOT International
    • OnQ Research
    • Research & Development RA S.A.
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    • Q-Trials
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    • Q2 Business Intelligence
    • ComboTrial
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News & Events

Home » News & Events

ClinDatrix Client REGiMMUNE Successfully Announced Findings of Phase 2b Study at the 2024 Tandem Meeting

July 12, 2024

TAIPEI, December 28, 2023 — REGiMMUNE Limited, a clinical-stage biopharmaceutical company dedicated to developing innovative immunotherapies for immune disorders and cancer, has announced promising Phase 2b clinical data. This study involves 48 patients who received RGI-2001 to prevent acute graft-versus-host disease (aGVHD). This Phase 2 study assesses the safety and efficacy of RGI-2001 in preventing …

ClinDatrix Client REGiMMUNE Successfully Announced Findings of Phase 2b Study at the 2024 Tandem MeetingRead More

Category: Uncategorized

REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2022 ASH Annual Meeting

November 9, 2022

TAIPEI, November 3, 2022 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announced that the Phase 2b clinical data from 49 patients receiving RGI-2001 for the prevention of acute graft-versus-host disease (aGVHD) will be presented at the 2022 American Society of Hematology (ASH) Annual Meeting …

REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2022 ASH Annual MeetingRead More

Category: Uncategorized

ClinDatrix provided full service for the successful Phase 3 study of renu® Advanced Formula Multi-Purpose Solution by Bausch + Lomb

May 22, 2017

ClinDatrix, Inc was contracted by Valeant Pharmaceuticals International, Inc. to provide full service clinincal research contracting for their phase 3 study of renu®. Valeant Pharmaceuticals is a wholly owned subsidiary, of Bausch + Lomb, a leading global eye health company. Renu® is a New & Improved Formula Builds on Trusted 30-Year Heritage of Meeting Consumers’ Lens …

ClinDatrix provided full service for the successful Phase 3 study of renu® Advanced Formula Multi-Purpose Solution by Bausch + LombRead More

Category: Press Releases

ClinDatrix Contract Research Organization Launches Oracle Health Sciences InForm 6.1 and Oracle Argus 8.0 to Speed Clinical Trials and Support Global Safety Collection and Risk Management Efforts

March 24, 2016

ClinDatrix, a leading full service contract research organization (CRO) located in Irvine, California, launches Oracle Health Sciences InForm 6.1 and Oracle Argus 8.0, to improve clinical development processes, streamline data capture, speed up trial timelines and enhance pharmacovigilance services. ClinDatrix is a full service CRO offering pre-clinical and clinical Phase I-IV project management services for …

ClinDatrix Contract Research Organization Launches Oracle Health Sciences InForm 6.1 and Oracle Argus 8.0 to Speed Clinical Trials and Support Global Safety Collection and Risk Management EffortsRead More

Category: Press Releases

ClinDatrix Joins Six Other CROs to Provide Global Services

May 15, 2014

Collaboration Will Ensure Local Monitoring and Centralized Clinical Research Technology for Sponsors of Multinational Clinical Trials IRVINE, CA, May 15, 2014 – ClinDatrix, Inc. has signed collaboration agreements with six contract research organizations (CROs) from around the world to form a consortium that offers services for multinational clinical trials. On joint projects, consortium members will …

ClinDatrix Joins Six Other CROs to Provide Global ServicesRead More

Category: Press Releases

Steve Balyakin, MD, PHD, FFPM, CMC Named Senior Medical Director for ClinDatrix, INC.

July 23, 2013

IRVINE, CA, July 23, 2013 – Steve Balyakin, MD, PhD, FFPM, CMC, recently was named Senior Medical Director of ClinDatrix, Inc. He will lead the patient safety and medical monitoring activities for the Irvine-based contract research organization (CRO). Prior to accepting the full-time position, Dr. Balyakin provided medical monitoring as aconsultant to ClinDatrix. “Steve has …

Steve Balyakin, MD, PHD, FFPM, CMC Named Senior Medical Director for ClinDatrix, INC.Read More

Category: Press Releases

ClinDatrix, Inc. Collaborates with its Biotechnology, Pharmaceutical and Medical Device Clients Globally to Advance New Products Through the Rigorous Development and Approval Process

January 28, 2013

BIO: Louise M. Murphy, PhD, MBA, CQA is President and CEO of ClinDatrix, Inc. Dr. Murphy has more than 25 years experience in research, 20 of these being in the pharmaceutical/biotechnology/CRO industry. Before co-founding ClinDatrix in 2002, Dr. Murphy was Vice President, Clinical Informatics at ICON Clinical Research. There she was responsible for the startup …

ClinDatrix, Inc. Collaborates with its Biotechnology, Pharmaceutical and Medical Device Clients Globally to Advance New Products Through the Rigorous Development and Approval ProcessRead More

Category: Media Coverage

Sineth Desai Joins ClinDatrix, Inc.; CRO Veteran to Lead Clinical Operations

October 16, 2012

IRVINE, CA, October 16, 2012 – Sineth Desai recently joined ClinDatrix, Inc. to head the Irvine-based contract research organization’s clinical department. In her new role as Director of Clinical Operations, Desai will serve as the key contact to the company’s clinical monitoring clients, oversee the firm’s clinical research associates and guide the expansion of the …

Sineth Desai Joins ClinDatrix, Inc.; CRO Veteran to Lead Clinical OperationsRead More

Category: Press Releases

Two ClinDatrix Executives Earn Their Certified Quality Auditor Certifications

June 19, 2012

IRVINE, CA, June 19, 2012 – ClinDatrix, Inc. announced today that two members of its executive team – Louise M. Murphy, PhD, MBA, and Ned Whittemore, PhD – have earned their Certified Quality Auditor (CQA) certifications from the American Society for Quality (ASQ). The certification, which requires intensive training and successful completion of a rigorous …

Two ClinDatrix Executives Earn Their Certified Quality Auditor CertificationsRead More

Category: Press Releases

Ground Zero Pharmaceuticals Announces Milestones In Pharmaceutical And Biotechnology Outsourcing Services

November 8, 2005

IRVINE, Calif., Nov. 8 /PRNewswire/ — The climate for pharmaceutical and biotechnology products has changed with increased emphasis on integrated product development, FDA reorganization, and recognition of the need for early markers of safety. Combination products are a major growth area. Strategic global planning and cost-effective development programs can lead to timely FDA approvals. The …

Ground Zero Pharmaceuticals Announces Milestones In Pharmaceutical And Biotechnology Outsourcing ServicesRead More

Category: Press Releases

BioGentech Announces ClinDatrix as CRO for Phase III Trials

April 29, 2004

IRVINE, Calif., April 29, 2004 (PRIMEZONE) — BioGentech Corp. (OTCBB:BGTH), a pharmaceutical company specializing in over-the-counter anti-allergy medications, announced today that it has entered into an agreement with Irvine based ClinDatrix, Inc. for the implementation, management and analysis of clinical investigations of BioGentech’s flagship product, Prehistin, for their upcoming Phase III trials. The Phase III …

BioGentech Announces ClinDatrix as CRO for Phase III TrialsRead More

Category: Press Releases

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