Regulations

Stay on top of the latest trend, best practices, and enabling technology in clinical research space through our latest blogs, webinars, white-papers and more about this topic.

White papers & guides

5 February 2024

eConsent Readiness Guide in 24 Countries

eConsent regulations can vary widely across borders. Download this whitepaper to learn the regulatory stances of 24 countries...

White papers & guides

eConsent Readiness Guide in 18 Countries

White papers & guides

29 November 2022

2023 Guide to Clinical Data Collection under the EU Medical Device Regulation (EU MDR)

Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this...

White papers & guides

27 January 2022

DTx Clinical Trials and Data Standardization

In this paper, Castor explores the benefits and challenges of Digital Therapeutics (DTx) trials and provides recommendations on...

White papers & guides

21 January 2022

Choosing Your Best Route to DTx Commercialization

In this guide, Castor discusses routes to digital therapeutics commercialization and tools to meet the challenges on the...

White papers & guides

18 January 2022

Navigating the DTx Regulatory Landscape

The regulations around digital therapeutics (DTx) are constantly changing. Learn how DTx providers are trying to overcome these...

White papers & guides

12 November 2021

Overview of EU Medical Device Regulations

Medical device regulations in the EU have recently undergone a major overhaul. Learn the key tenets of MDR...

White papers & guides

eConsent Readiness in 12 Countries

eConsent is imperative for continuing research during the COVID-19 pandemic and beyond, but regulations can vary widely across...

White papers & guides

Demystifying CDISC standards in the modern era of Decentralized Clinical Trials

Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this...

White papers & guides

Essential Guide to Post-Market Clinical Follow-Up (PMCF) for Medical Devices

Learn the full impact of PMCF under the EU MDR and how to best prepare your medical device...

White papers & guides

26 January 2021

A Guide to Capturing and Managing Data in Digital Therapeutics Trials

This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote...

White papers & guides

30 November 2020

eBook: The Decentralized Clinical Trial Playbook

This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote...

White papers & guides

The Impact of ISO 14155 on PMCF Investigations Under the MDR

Download this white paper to prepare for the new MDR requirements requiring that PMCF investigations be conducted in...

White papers & guides

5 steps to meet PMCF requirements

Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR...

White papers & guides

Satisfying PMCF requirements by utilizing IIS data

This white paper describes an approach that would enable medical device manufacturers to leverage anonymous data from IIS...

White papers & guides

In-Vitro Diagnostic Regulation (IVDR): From oversight to overhead

The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the...

White papers & guides

6 essential steps to ensure Medical Device Regulation (MDR) compliance before May 2021

July 17th 2020: This document has been updated to reflect regulatory changes in response to COVID-19. As this...

White papers & guides

What does the Medical Device Regulation (MDR) tell us about Post-Market Surveillance?

With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for...

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