EUCROF: EMA Clinical Trials Information System (CTIS) CRO / Sponsor Organization Models in CTIS

Datum: 13 July 2022
Locatie: Webinar

In the current transition period, organizations focus on the setup of the optimal organisation model in CTIS, which ensures a smooth collaboration between CROs and Sponsors and enables optimal use of the standardized timelines of EU CTR.

In this Webinar, Marieke Meulemans explores the possible organisation models and discusses different scenarios around this topic. An organisation-centric model with a Sponsor Admin overseeing assignment of Clinical Trial Admins seems to be the most logical execution model for most of the (big) CROs and Sponsors. What is the best organisation model for small and mid-sized CROs? How will access be granted to CROs? And what Organisation model to propose to your Sponsor in a multi-CRO model? The sponsor would probably want to restrict access, without impacting the collaboration. Attending this webinar makes you aware of the possible organisation models in CTIS and what scenarios CROs can propose to their clients.

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EUCROF: EU Clinical Trial Regulation 536/2014 (CTR): Transitional Provisions and New Concepts

Datum: 30 March 2022
Locatie: Webinar

With the EU Clinical Trial Regulation becoming effective on 31 January 2022, a new era of clinical trials with medicinal products has begun in the EU/EEA. The EU legislator provided for a 3-year transition period in which the former system under the EU Clinical Trials Directive and the new system under the EU Clinical Trial Regulation are available in parallel. Sponsors need to know how to best use this period for ongoing clinical trials, but maybe also for trials that are soon to be submitted. Strategic decisions will be necessary and the switch from one legal framework to the other must be well understood.

In this Webinar, the transitional provisions will be explained and different scenarios will be discussed around this topic. What is a harmonised trial protocol versus a consolidated protocol when making the switch from the old to the new system? And what happens to IMP on-site when transition from one system to the other is taking place? Many questions around the transition will be addressed in this Webinar. Finally, the CTR is offering new concepts in comparison to the EU Clinical Trials Directive (co-sponsorship, low-intervention clinical trials) – those topics will also be discussed in this Webinar.

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EUCROF: Trial Master File Archiving and the Decommissioning of Computerised Systems

Datum: 20 October 2021
Locatie: Webinar

The archiving of clinical trial records is a required process that is in need of future direction to meet current business models as well as regulatory and legal expectations. A group of industry experts coalesced under EUCROF and the eClinical Forum to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research.

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EUCROF: Future of Clinical Trials: Navigating Complexities to Increase Investigator Satisfaction

Datum: 5 October 2021
Locatie: Webinar

Since the outbreak of COVID-19, clinical trials have become even more complex and competitive. In order to ensure success and meet patient enrollment targets, sponsors not only need to attract the best investigator sites, but also need to focus firmly on the patient through new ways of working, such as utilizing new routes and adjusting study protocols, including a rise in demand for direct-to-patient delivery.

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EUCROF: The Home Care Services – Useful Tool for Decentralized Clinical Trials

Datum: 31 August 2021
Locatie: Webinar

During this webinar questions regarding what specific opportunities exist to deliver home care services in clinical trials or why does HHC services make sense for clinical trials will be answered and many more.We believe that the future of clinical trials will be decentralized, with home-based care providers set to play an important role in making it all possible.

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