chcuk@syneoshealth.com
  • Home
  • Contact
CHCUK
  • NIS
    • NIS Definitions
    • Study Classification
    • NIS Training Solutions
    • NIS Country-Specific Reports
    • NIS Regulatory Database
    • NIS Regulatory Consulting
    • NIS Resources & Useful Links
    • RWR Glossary
  • PCTs
    • PCT Definitions
    • PCT Regulatory Consulting
    • PCT Useful Links
    • RWR Glossary
  • GCP
    • GCP Definitions
    • GCP Useful Links
    • RWR Glossary
  • News
  • About
  • Contact
Select Page

Survey – Pragmatic Clinical Trials

by chuck_ltd | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials

It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...

The RWE Equation: Finding the Right Late-Stage Study Design

by chuck_ltd | 10 Sep, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, White Paper

White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory...

ABPI – Real World Evidence Workshop Report Published

by chuck_ltd | 5 Aug, 2016 | CHCUK News & Articles, HTA, NIS, Pragmatic Trials, Real Word Evidence

The ‘Real world evidence’ workshop was held on 17 September 2015 as part of the Academy’s FORUM programme. It brought together participants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and...

Webinar: Pragmatic Studies for Real World Evidence – Lifting the Veils

by chuck_ltd | 24 Feb, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, HTA, News, NIS, Pragmatic Trials, Real Word Evidence, Webinar

Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle....

What are Pragmatic Clinical Trials?

by chuck_ltd | 22 Nov, 2015 | CHCUK News & Articles, News, Pragmatic Trials

There has been a recent resurgence in the use of the term ‘pragmatic clinical trial’, but what are they? This free report (2015-11-22_Pragmatic-Clinical-Trials_CHCUK#1) summarises the current literature, proposed legislative changes (i.e., the EU Clinical Trials...

Categories

  • 21 Century Cures Act
  • 3D Printers
  • AI
  • Biological Products
  • Biosamples
  • Biosimilars
  • Brexit
  • CHCUK News & Articles
  • CHCUK NIS Database
  • Consultation
  • Cures Act
  • Cybersecurity
  • Data Integrity
  • Data Privacy
  • Digital Health Technology
  • EAP
  • eConsent
  • EFPIA
  • EHR
  • eletronic Signatures
  • EMA
  • EU Clinical Trials Regulation
  • FDA 1572
  • FDA Guidance
  • FDAMA114
  • GCP
  • GCP Inspections
  • GDPR
  • Genetic Research
  • GVP
  • HIPAA
  • HTA
  • Human Tissue Research
  • Immunological Products
  • Informed Consent
  • Market Access
  • Medical Apps
  • Medical Devices
  • News
  • NIS
  • NIS Considerations Report
  • Orphan Drugs
  • PASS
  • Patient Centricity
  • Pragmatic Trials
  • Professional Standards
  • Promotion and Advertising
  • PROs
  • Publication Guidelines
  • Rare Diseases
  • Real Word Evidence
  • Real World Evidence
  • Real World Research Design
  • Registry
  • Regulatory Grade RWE
  • Regulatory Intelligence
  • Regulatory Science
  • Reimbursement
  • RWD
  • Safety Management
  • Sunshine Regulations
  • Transparency
  • Uncategorized
  • Virtual Clinical Research
  • Webinar
  • White Paper

News

December 2023
M T W T F S S
 123
45678910
11121314151617
18192021222324
25262728293031
« Feb    

Legal Information:

  • Terms & Conditions
  • Disclaimer
  • Privacy Notice

• CHCUK NIS Regulatory Database
• Contact CHCUK

  • Facebook
  • X
Copyright © 2023 CHCUK. All Rights Reserved.

design by Poppy Design