Staburo @ the DIA Global Clinical Trial Disclosure & Data Transparency Conference 2020

Staburo @ the DIA Global Clinical Trial Disclosure & Data Transparency Conference 2020

Staburo @ the DIA Global Clinical Trial Disclosure & Data Transparency Conference 2020 

Staburo participated in the 2020 Global Clinical Trial Disclosure & Data Transparency Conference hosted by the Drug Information Association (DIA) from the 16 – 18 November, this year online due to – you guessed it – covid19.

During the conference different regulatory agencies such as the FDA and the EMA provided updates concerning their disclosure platforms. The FDA provided an overview of new and upcoming features of ClinicalTrials.gov which are of immediate use to us in our day to day work disclosing studies on this platform. The EMA discussed the upcoming release of their new central European disclosure platform CTIS (Clinical Trials Information System) which will mark a major shift in the way clinical trials are disclosed in the EU.

Besides the regulatory agencies a range of industry experts joined the conference, leading to interesting discussions about topics such as the global harmonization, BREXIT, disclosing medical device studies and the future of clinical trial regulation. These talks provided valuable insights into the current state and future goals of global clinical trial disclosure.

We are looking forward to participating in next year’s conference where we can hopefully meet the speakers and attendees in real life!

If you have any questions about our disclosure services, don’t hesitate to contact us!

 

Data analysis, clinical biostatistics and more.

Staburo @ working group pharmaceutical research (APF) workshop

Staburo @ working group pharmaceutical research (APF) workshop

Staburo @ APF Workshop

Staburo @ working group pharmaceutical research (APF) workshop 

Staburo Managing Director Dr. Hannes Buchner will talk about “Estimands update: Summary of world-wide authority interaction” together with Kaspar Rufibach from Roche at the 74th Arbeitsgruppe Pharmazeutische Forschung (APF) workshop on November 27, 2020.

The current workshop will take place virtually on November 27, 2020, on the topic “COVID-19: Effects on statistics, methodological aspects and operational implications”. The current agenda can be found here: http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/PharamzeutischeForschung/PDFs/Agenda_APF_74_virtuell_Nov_2020.pdf

APF aims to establish contacts between biometricians working in pharmaceutical research and development, to accelerate the exchange of methods among colleagues and, if necessary, to develop new methods, as well as to transport mutual information on official regulations, methodological developments and scientific events.

Pre-registration for the workshop and for the virtual evening meeting is required and can be done here: http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/PharamzeutischeForschung/PDFs/Anmeldung_APF_Workshop_Nov2020_01.pdf 

To register, please download the registration form, fill it out and follow the instructions in the document. Registration is requested by November 20, 2020.

Data analysis, clinical biostatistics and more.