NEWS on 19 January 2021:
The COVID-19 pandemic brought about quite a few changes. One of my current trials is being terminated prematurely, others will only start with a delay, and enrolling new participants into ongoing trials is hindered.
I currently support my clients with their oversight by rolling out remote/central monitoring activities, using the rapport I have built with site staff. It is second-best to the hands-on and personal approach during on-site visits, but it offers benefits nevertheless.
Should you need my consultancy; I do have room on my agenda.
Being an entrepreneur, I always pay attention to future developments. I also try to keep a list of projects ‘in the pipeline’, for future consideration. This is Business Development at work. To name a few:
- How will the EU Clinical Trial Directive (EC 536/2014) work out? Implemented already in the Netherlands is the so called ‘Verklaring Geschiktheid Onderzoekslocatie (VGO)’; in English ‘Institutional Local Feasibility’, a procedure that may already be followed since Dec 2020 to gain the Institution’s Board of Directors’ approval
- ACTRIS is a newly developed application that aims at risks and issues management, decision making, to integrate into reporting by using hyperlinks to the specific issue. It was tested recently with one of my clients, as an extended service. A demo version is available for testing purposes.
- the way that the open source eCRF software LibreClinica (LC) can be employed by small and even large groups of investigators, remains attractive. Not only for its rather low operational costs. Since a few years, I partner with an independent data manager / LC expert, to offer LC in conjunction with central monitoring services. Recently LC was offered in two Requests for Proposals (one is a phase I, the other a phase IV)