Castor White Papers

Access white papers related to clinical research regulations and issues including the MDR, IVDR, the FDA approval process, ISO 14155, and decentralized trials.

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

14 October 2020

Guide to using Electronic Data Capture (EDC) for Medical Device & Diagnostics Trials

Download this guide to learn how to incorporating an Electronic Data Capture (EDC) system in your medical or...

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

Using Decentralized Trial Technology to Ensure Study Continuity and Data Quality During COVID-19 and Beyond

Download this white paper to learn why patient-centric, remote research technologies such as eConsent, EDC, and ePRO are...

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...

White papers & guides

Three expected changes to FDA medical device approval

2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul...

White papers & guides

4 ways the Medical Device Regulation (MDR) will impact your device studies

Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As...

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