Webinar Archives | Castor EDC

Webinar (on-demand):
An Expert Panel on Decentralized and Hybrid Trials, Pre and Post COVID-19

May 28th, 2020 by Himanshu Pant

The world may have changed seemingly overnight, but clinical research and medical innovation must continue now more than ever. This webinar, presented on International Clinical Trials Day, discusses how to decentralize your trials in order to keep them going during the COVID-19 pandemic. Decentralized and hybrid clinical trials (DCTs) offer a more patient-centric approach in which fewer clinic visits are required and patient and caregiver burden are reduced. During this time, DCTs are critical to maintain patient safety, data quality and research continuity.

Featuring Craig Lipset, former Head of Clinical Innovation at Pfizer, Kai Langel, Director of Clinical Innovation at Janssen, Paul Bodfish, VP of Corporate Services at the Medical Research Network, and Derk Arts, MD, PhD, Founder and CEO of Castor. These experts discuss the following topics:

Issues faced by clinical researchers due to the COVID-19 pandemic
The approach, benefits and challenges of conducting decentralized & hybrid trials
A guide to implementing remote enrollment, screening, eConsent and data capture
How to engage with patients via ePRO, native diary apps and video calls
How to combine data from eCRF, eCOA, ePRO, wearables and EHR data into one platform

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Webinar: Research Continuity During COVID-19

April 17th, 2020 by Himanshu Pant

Watch this webinar for tips on how to ensure research continuity during COVID-19 by running your trial with a more decentralized approach.

The COVID-19 pandemic is disrupting almost every aspect of life in some way. Clinical trials are no exception, and many researchers are concerned that their studies may be delayed or paused indefinitely as the pandemic progresses.

In this webinar, Derk Arts, MD, PhD, CEO of Castor, and Baljit (Boo) Samra, Strategic Advisor and former COO of Duke Clinical Research Institute, share expert insights on how to continue moving your research forward during this pandemic.

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Webinar (on-demand):
A step-by-step tutorial on creating an approved PMCF plan

April 1st, 2020 by Himanshu Pant

Under the MDR, PMCF activities will be mandated as part of medical device surveillance programs. These activities should ultimately ensure patient safety through continuous monitoring of certain medical devices. While conducting PMCF activities may appear costly and burdensome, this process can be streamlined and even automated through technology.

During this webinar, we presented a step-by-step approach to defining a successful PMCF plan and discussed different PMCF scenarios and design types. Featuring Derk Arts, MD, PhD, Founder and CEO of Castor, and Nadine Leistner, PhD, Chief Scientific Officer of MEC-ABC Medical Care and Product Development.

We illustrated the steps needed to put together a PMCF plan that will pass Notified Body scrutiny. We also showed how you can put technology to work to support you with a wide array of PMCF approaches. Specifically, we discussed the following topics:

Analysis of existing clinical data (clinical evaluation and instruction for use)
Performing claim analysis and PMCF parameter deduction
Justification of parameter, sample size and selection bias
Selecting a PMCF approach and enrollment strategy
Selecting a platform that suits the approach

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Webinar (on-demand):
Top EU MDR questions answered by MDR experts

December 10th, 2019 by Himanshu Pant

In this webinar, two experts (including an expert from a notified body) answer the most pressing MDR questions.

Dr. Matthias Fink, Clinical Reviewer at TÜV SÜD (an MDR notified body) and Dona Occhipinti, Medical Affairs EU MDR Project Manager and Independent Consultant, dive into questions such as:

1) Do we always need to claim equivalence or just with a CE-marked device?

2) What are the implications of the MDR on clinical trials and for the investigators?

3) What is the difference between the Clinical Development Plan and Post Market Clinical Follow-up Plan? (Annex XIV MDR)

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Webinar (on-demand):
6 essential steps to ensure MDR compliance before May 2020

November 19th, 2019 by Himanshu Pant

A recent report surveying representatives from the medical device industry across the world found that more than 55% claimed only a basic understanding of how to prepare for MDR compliance. With 4 months left, the time to act is now.

During this webinar, we discuss 6 essential tasks you need to complete before May 2020.

Featuring Dr. Matthias Fink, Clinical Reviewer at TÜV SÜD (an MDR notified body) and Dona Occhipinti, Medical Affairs EU MDR Project Manager and Independent Consultant, we dive into the following topics:

Renewal of certificates under MDD and choosing devices to keep on the EU market.
Ensuring you have sufficient data for legacy devices and effective strategies to start clinical investigations if you don’t.
Preparing for SSCP and PMCF requirements under the MDR.
Live Q&A with our panel to get answers to your most pressing questions about MDR.

Who Should Watch:

This webinar would appeal to senior professionals within the medical device industry in the areas of:

Clinical / Medical Affairs
Clinical Operations
Regulatory Affairs / Compliance
Medical Research and Development
Clinical Data Management
Medical Device Manufacturing
Contract Research Organizations

What You Will Learn:

Viewers will learn about:

Steps to prepare for MDR 2020
Clinical data requirements under the MDR
Preparation for Post-Market Clinical Follow-up (PMCF)
Actionable tips to help transition your medical devices under MDR

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Webinar (on-demand):
Understanding GDPR and its impact on clinical research

October 22nd, 2019 by Himanshu Pant

Understanding the GDPR requirements and their impact on clinical research can be quite challenging.

Watch an interactive webinar with

Caroline Cabezas (Legal Counsel & Privacy Officer at Castor)
Rahel Meister (Senior Clinical Study Manager at Smith & Nephew)

What you’ll learn:

1. How the GDPR requirements affect clinical research, specifically patient informed consent and data management

2. Data minimization for researchers

3. And lastly, what really happens during a data breach

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Webinar: The future of data standardization in medical research: FHIR and FAIR

June 19th, 2019 by Himanshu Pant

Medical research data holds the key to solving the world’s greatest healthcare challenges. It is therefore, one of the most valuable assets in existence. Why then, is research data rarely standardized, exchanged, or reused? Making the most of this precious data is key to reducing research waste.

In this webinar, we painted a picture of the future of medical research data. From the practical challenges faced when reusing EHR data through HL7 FHIR, to the potential of fully machine-readable, standardized research data (FAIR), we discussed technology and trends that are paving the way for the distribution of datasets at a scale the world has never before seen.