Contract research organization

Psyence Biomedical’s Subsidiary, Psyence Australia, Receives Human Research Ethics Committee (HREC) Approval to Initiate Phase IIb Study

Retrieved on: 
Wednesday, March 6, 2024

NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.

Key Points: 
  • NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.
  • The study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context.
  • Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENū Pty Ltd ("iNGENū"), to design and execute the clinical trial.
  • Psyence anticipates enrolling the first patient in Q2 2024 and expects the primary endpoint results to be available in 2025.

Intelligent Bio Solutions Partners with Cliantha Research to Conduct Clinical Study as Part of FDA 510(k) Pathway

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. ("INBS" or the "Company") (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with Cliantha Research , a full-service Clinical Research Organization (CRO), to perform a pharmacokinetic (PK) study forming part of the Company’s FDA 510(k) clinical study plan.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. ("INBS" or the "Company") (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with Cliantha Research , a full-service Clinical Research Organization (CRO), to perform a pharmacokinetic (PK) study forming part of the Company’s FDA 510(k) clinical study plan.
  • The fingerprint sweat specimen will be screened using INBS’ Intelligent Fingerprinting Drug Screening System comprising the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader and compared to the LC-MS/MS results.
  • The start of the clinical study plan marks an exciting milestone for the Company as it advances on its 510(k) pathway.
  • Harry Simeonidis, President and CEO at Intelligent Bio Solutions, commented, “We are pleased to share news of our partnership with Cliantha and progress on our 510(k) journey.

Novotech Publishes Duchenne Muscular Dystrophy Landscape Report to Support Biotech Research Planning

Retrieved on: 
Wednesday, February 28, 2024

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Novotech , the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released today an industry-leading report on Duchenne Muscular Dystrophy (DMD) Clinical Trial Landscape .

Key Points: 
  • BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Novotech , the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released today an industry-leading report on Duchenne Muscular Dystrophy (DMD) Clinical Trial Landscape .
  • The Novotech research analyst team provides these expert reports monthly, completely free of charge.
  • They tackle the hurdles faced by biotech firms in specific therapeutic areas and discuss future paths in therapy and investment trends.
  • This comprehensive resource guides healthcare professionals, researchers, and organizations in navigating the complex clinical trial DMD landscape.

Calian Wins Contract to Support Clinical Trial for ZYUS Life Sciences’ Lead Drug Product Candidate

Retrieved on: 
Tuesday, February 20, 2024

Calian's full-service Contract Research Organization (CRO) will apply its extensive clinical trial management experience to support a Phase 2 Clinical Trial for Trichomylin softgel capsules.

Key Points: 
  • Calian's full-service Contract Research Organization (CRO) will apply its extensive clinical trial management experience to support a Phase 2 Clinical Trial for Trichomylin softgel capsules.
  • “Calian will apply our industry-leading expertise to support this Phase 2 Clinical Trial and further ZYUS’ pursuit of transformational impact on patients’ lives,” says Derek Clark, President, Calian Health.
  • Calian will provide full-service, end-to-end expertise to support this trial, including medical writing, regulatory affairs, clinical operations, site monitoring, data management, medical monitoring and quality assurance.
  • By collaborating with an industry leading contract research organization with extensive experience in clinical trial management, we can leverage invaluable knowledge and expertise."

Managing Service Providers Including CRO and CMOs Oversight to Comply with ICH GCP R3 Training Course (April 18-19, 2024) - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 29, 2024

The "Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • A company's ability to identify and select the right CRO/ vendor for the right project and manage them efficiently and effectively will help to ensure compliance with the regulator's expectations.
  • You will also cover the techniques for successfully managing CROs/ vendors and the shared responsibilities required by the sponsor and the service provider.
  • The course is equally useful to CROs/other vendors and consultants to understand how to work effectively with sponsor organisations.

IRBM Expands Global Reach in Drug Discovery with New Boston Office

Retrieved on: 
Tuesday, March 5, 2024

ROME, March 5, 2024 /PRNewswire/ -- IRBM, an integrated drug discovery Contract Research Organization (CRO), announces its global expansion with a new office in Boston, Massachusetts, a cornerstone for biotechnology and drug discovery. This strategic initiative underscores IRBM's dedication to fostering innovation and collaboration within the life sciences sector, aiming to harness Boston's dynamic biotech ecosystem for the accelerated development of therapies that address unmet medical needs on a larger scale.

Key Points: 
  • ROME, March 5, 2024 /PRNewswire/ -- IRBM, an integrated drug discovery Contract Research Organization (CRO), announces its global expansion with a new office in Boston, Massachusetts, a cornerstone for biotechnology and drug discovery.
  • Expanding IRBM's global reach, the Boston site will enhance direct interactions with partners, collaborators, and the broader scientific community across the United States and internationally.
  • This move reinforces IRBM's mission to improve health outcomes through innovative research and an integrated, collaborative approach to drug discovery.
  • The introduction of IRBM's Boston office and the launch of its redesigned website signify major strides in the company's global outreach and digital engagement.

IRBM Expands Global Reach in Drug Discovery with New Boston Office

Retrieved on: 
Tuesday, March 5, 2024

ROME, March 5, 2024 /PRNewswire/ -- IRBM, an integrated drug discovery Contract Research Organization (CRO), announces its global expansion with a new office in Boston, Massachusetts, a cornerstone for biotechnology and drug discovery. This strategic initiative underscores IRBM's dedication to fostering innovation and collaboration within the life sciences sector, aiming to harness Boston's dynamic biotech ecosystem for the accelerated development of therapies that address unmet medical needs on a larger scale.

Key Points: 
  • ROME, March 5, 2024 /PRNewswire/ -- IRBM, an integrated drug discovery Contract Research Organization (CRO), announces its global expansion with a new office in Boston, Massachusetts, a cornerstone for biotechnology and drug discovery.
  • Expanding IRBM's global reach, the Boston site will enhance direct interactions with partners, collaborators, and the broader scientific community across the United States and internationally.
  • This move reinforces IRBM's mission to improve health outcomes through innovative research and an integrated, collaborative approach to drug discovery.
  • The introduction of IRBM's Boston office and the launch of its redesigned website signify major strides in the company's global outreach and digital engagement.

MCRA Announces the Hiring of FDA Statistician for Diagnostic Devices

Retrieved on: 
Thursday, February 22, 2024

WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.

Key Points: 
  • WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.
  • MCRA hires FDA Mathematical Statistician, Diagnostic Devices Chava Zibman Ph.D. as Principal Statistician, Diagnostics.
  • Dr. Zibman brings over fifteen years of statistical experience and over ten years of direct FDA experience to the position, working in the Center for Devices and Radiological Health (CDRH).
  • I am eager to help MCRA grow as the preferred consulting firm for companies seeking statistical assistance for their diagnostic devices."

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System

Retrieved on: 
Tuesday, February 20, 2024

MCRA aids Curiteva with 510(k) clearance from FDA for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System.

Key Points: 
  • MCRA aids Curiteva with 510(k) clearance from FDA for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System.
  • Curiteva partnered with MCRA previously on Inspire Trabecular PEEK Cervical Interbody Fusion System in February 2023, which also received FDA clearance.
  • MCRA's Spine Regulatory team engaged with Curiteva for the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.
  • Justin Eggleton, Vice President, Head of Musculoskeletal Regulatory Affairs at MCRA, said "MCRA is honored to have collaborated on the pioneering project of Curiteva's Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System with HAFUSE Technology and the resulting FDA clearance.

Avance Clinical and Ryght Partner to Bring Novel GenAI Technologies to Clinical Research Networks

Retrieved on: 
Tuesday, February 20, 2024

Under the terms of this partnership, Avance Clinical will gain access to Ryght's advanced GenAI technology, which utilizes various large language models (LLMs) fine-tuned for the sector to process live data streams and complex data, delivering actionable insights to clinical research groups.

Key Points: 
  • Under the terms of this partnership, Avance Clinical will gain access to Ryght's advanced GenAI technology, which utilizes various large language models (LLMs) fine-tuned for the sector to process live data streams and complex data, delivering actionable insights to clinical research groups.
  • Avance Clinical, a leading company in the CRO sector, is dedicated to fostering innovation and enhancing patient care with cutting-edge technologies.
  • The incorporation of the Ryght platform into its research networks will enable Avance Clinical to optimize workflows, boost operational efficiency, and unlock new potential for collaboration and discovery.
  • "We are thrilled to collaborate with Ryght and utilize their GenAI platform to advance our clinical trial processes," stated Yvonne Lungershausen, CEO of Avance Clinical.