• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Bye-Bye China?

    Decentralized Trials Fuel AI Revolution in Clinical Research

    Self-Medication: Flexibility for Patients and Drug Manufacturers

    The Single-Use Mixing Landscape: Evaluating Your Options

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio

    Frontage Bolsters Clinical Services Capabilities

    Sanofi Unveils EUROAPI as Name of New European API Company

    Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

    Precision Medicine Group Acquires Project Farma
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Sanofi Unveils EUROAPI as Name of New European API Company

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza

    Fujifilm, CABIM Get $76M Funding for Mfg. and Innovation Center

    LSNE Expands Fill Finish and Lyophilization Ops
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

    Varcode, PL Developments Form Strategic ‘Smart Tag’ Pact

    COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

    Thermo Fisher Expands Clinical Supply Services in Europe

    Schreiner MediPharm Joins DoseID Consortium
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Virtual Clinical Trials: The Future of Dermatology Studies

    Frontage Bolsters Clinical Services Capabilities

    Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

    CDMO Cognate BioServices Teams Up with L7 Informatics

    The Wasdell Group Earns ISO 13485 Certification
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Reed-Lane

    Syngene

    Cytovance Biologics

    Adare Pharma Solutions

    Baxter BioPharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Cytovance Biologics

    PCI Pharma Services

    Adare Pharma Solutions

    Flow Sciences

    Emergent BioSolutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Extends CRADA with CluePoints

    Aims to further explore a data-driven approach to quality oversight in clinical trials

    Related CONTENT
    • Mogene
    • Orchestra BioMed Appoints Chief Medical Officer
    • FDA Approves Antibiotic for Community-Acquired Pneumonia
    • Marken Expands Services for Home-based Clinical Trials
    • Roche Wins Two Approvals for Cancer Drug Rozlytrek
    09.11.19
    The FDA has extended its Cooperative Research and Development Agreement (CRADA) with CluePoints to October 2021 to include additional research focused on “moderators of treatment effect” and real-world evidence. Additional analyses based on these moderators of treatment effect will include geographic region, country and supervising Contract Research Organizations (CROs).
     
    The FDA also plans to conduct statistical tests provided by CluePoints such as Key Risk Indicators (KRIs) that will supplement the existing data-driven approach to selecting sites for inspection using a risk-based approach.

    The FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during clinical research. Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk. With the volume of product submissions, the FDA can only inspect a small proportion of clinical trial sites. The determination of which sites to inspect can involve recommendations by clinical and statistical reviewers, CDER’s Risk-Based site selection tool and FDA inspectors’ judgment and experiences.
     
    The  initial Cooperative Research and Development Agreement (CRADA) between FDA and CluePoints began looking at a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness.  Under this CRADA, FDA and CluePoints, Inc. have developed and tested enhancements to CluePoints’ existing software to produce an ordered list of “anomalous sites”; added statistical tests and models to those already in the software; refined the scoring system used to identify outlying centers.
     
    Related Searches
    • Clinical Trials
    • clinical research
    • Clinical Trial
    • Contract Research
    Suggested For You
    Mogene Mogene
    Orchestra BioMed Appoints Chief Medical Officer Orchestra BioMed Appoints Chief Medical Officer
    FDA Approves Antibiotic for Community-Acquired Pneumonia FDA Approves Antibiotic for Community-Acquired Pneumonia
    Marken Expands Services for Home-based Clinical Trials Marken Expands Services for Home-based Clinical Trials
    Roche Wins Two Approvals for Cancer Drug Rozlytrek Roche Wins Two Approvals for Cancer Drug Rozlytrek
    FDA Approves New Treatment for Drug-Resistant TB FDA Approves New Treatment for Drug-Resistant TB
     The 4th World Congress on Clinical Trials in Diabetes The 4th World Congress on Clinical Trials in Diabetes
    Atlasciences Appoints Chief Scientific Officer Atlasciences Appoints Chief Scientific Officer
    NIIMBL, FDA to Advance Innovation in Bio Manufacturing NIIMBL, FDA to Advance Innovation in Bio Manufacturing
    FDA Accepts RedHill Biopharma’s NDA for Talicia FDA Accepts RedHill Biopharma’s NDA for Talicia
    Syndax Pharma Gets IND Clearance for Leukemia Treatment Syndax Pharma Gets IND Clearance for Leukemia Treatment
    The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up? The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?
    International Congress on Clinical Trials in Cannabis International Congress on Clinical Trials in Cannabis
    Sierra’s Momelotinib Granted FDA Fast Track Designation Sierra’s Momelotinib Granted FDA Fast Track Designation
    Parexel to Collaborate with CluePoints Parexel to Collaborate with CluePoints

    Related Breaking News

    • Breaking News | Clinical Trials | CRO News | Industry News
      Frontage Bolsters Clinical Services Capabilities

      Frontage Bolsters Clinical Services Capabilities

      Unveils plans to provide full service human radiolabeled absorption, metabolism, and excretion study capabilities.
      Contract Pharma Staff 01.15.21

    • Breaking News | Clinical Trials | CRO News
      Parexel Completes Strategic Separation

      Parexel Completes Strategic Separation

      Aims to simplify and streamline business strategy and customer relationships while positioning both organizations for long-term growth.
      Contract Pharma Staff 01.12.21

    • Clinical Trials | CRO News
      Caprion-HistoGeneX Acquires Clinical Logistics

      Caprion-HistoGeneX Acquires Clinical Logistics

      Expands its support of clinical trials specimen logistics.
      Contract Pharma Staff 01.08.21


    • Breaking News | Clinical Trials | Promotions & Moves
      Parexel Appoints Chief Patient Officer

      Parexel Appoints Chief Patient Officer

      Demonstrates the company’s commitment to elevating the patient perspective.
      Contract Pharma Staff 01.06.21

    • Breaking News | Clinical Trials | CRO News
      Genesis Biotechnology Acquires STATKING Clinical Services

      Genesis Biotechnology Acquires STATKING Clinical Services

      Expands its presence in the clinical space.
      Contract Pharma Staff 01.06.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
      Akston Biosciences and LakePharma Enter Covid-19 Partnership

      Akston Biosciences and LakePharma Enter Covid-19 Partnership

      Will manufacture second-generation COVID-19 vaccine, AKS-452.
      Contract Pharma Staff 01.05.21


    • Breaking News | Clinical Trials | CRO News | Drug Development
      Ergomed Acquires MedSource

      Ergomed Acquires MedSource

      Specialist oncology and rare disease CRO further expands Ergomed’s presence in the U.S. market.
      Contract Pharma Staff 12.15.20

    • Breaking News | Clinical Trials | Industry News
      SGS Initiates U.S. COVID-19 Clinical Trials

      SGS Initiates U.S. COVID-19 Clinical Trials

      Phase 2/3 trial will examine the safety, tolerability, and efficacy of Sarconeos (BIO101) to treat COVID-19 related respiratory failure.
      Contract Pharma Staff 11.30.20

    • Breaking News | Clinical Trials | Industry News
      Merck Acquires OncoImmune for $425M

      Merck Acquires OncoImmune for $425M

      Acquisition adds to Merck’s suite of clinical programs in response to SARS-CoV-2/COVID-19.
      Contract Pharma Staff 11.24.20


    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
      Pfizer and BioNTech to Submit EUA for COVID-19 Vaccine

      Pfizer and BioNTech to Submit EUA for COVID-19 Vaccine

      Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.
      Contract Pharma Staff 11.20.20

    • Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Facilities | Industry News
      Novavax Expands Facility to Support Global Vaccine Development

      Novavax Expands Facility to Support Global Vaccine Development

      Expands campus with two properties to support vaccine research and development, manufacturing, business operations.
      Contract Pharma Staff 11.10.20

    • Breaking News | Clinical Trials | CRO News
      BARDA Reselects ICON as Preferred Partner

      BARDA Reselects ICON as Preferred Partner

      Continues as part of BARDA’s exclusive Medical Countermeasures Clinical Studies Network
      Contract Pharma Staff 10.29.20


    • Breaking News | Clinical Trials
      Thermo Fisher Expands Direct-to-Patient Service

      Thermo Fisher Expands Direct-to-Patient Service

      Offering now includes Clinical Site-to-Patient, Pharmacy-to-Patient and Depot-to-Patient services to enable medication delivery directly to patients' homes.
      Contract Pharma Staff 10.27.20

    • Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
      Moderna Completes Enrollment in Phase III COVID-19 Vax Study

      Moderna Completes Enrollment in Phase III COVID-19 Vax Study

      COVE study designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease in 30,000 participants.
      Contract Pharma Staff 10.22.20

    • Breaking News | Clinical Trials
      CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin

      CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin

      Phase 2 trial will commence during the first quarter of 2021.
      Contract Pharma Staff 10.20.20

    Trending
    • Catalent Acquires Acorda’s INBRIJA Manufacturing Operations
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Baxter, Novavax Ink Sterile Manufacturing Agreement
    • Precision Medicine Group Acquires Project Farma
    • Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    Breaking News
    • KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    • Frontage Bolsters Clinical Services Capabilities
    • Sanofi Unveils EUROAPI as Name of New European API Company
    • Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    • Precision Medicine Group Acquires Project Farma
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up
    • Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    • Inspecting the Unexpected
    • Cold Chain Trends
    • Catering for the Complex
    • Biopharma Contract Manufacturing: Robust Growth Ahead
    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    • The Single-Use Mixing Landscape: Evaluating Your Options
    • Self-Medication: Flexibility for Patients and Drug Manufacturers
    • Decentralized Trials Fuel AI Revolution in Clinical Research
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    Amyris Named a Top Social & Environmental Impact Company
    L'Oréal Bans Animal Hair in Brushes
    Ashland Launches Antaron ECo Gel
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login