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SAVE THE DATE

When? October 15th 2020
Where? Cercle Du Lac, Louvain-La-Neuve

12h00 Welcome lunch
13h00 CRO vs Biotech/Pharma battle
17h30 Networking Cocktail
19h00 BeCRO 10th anniversary dinner

Ask what you never dared to ask!
More details will follow...

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On 30th April, FAMHP published V2 of the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

Please note that this document is to be read in conjunction with the latest version of the European guidance and that the national guidance provides some more detailed clarifications and additional topics of interest. This text was written by the FAMHP, the Clinical Trial College and the Belgian association of Research Ethics Committees (BAREC).The information […]

Read More "On 30th April, FAMHP published V2 of the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic"

Draft points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

On 25th March, EMA issued a draft guidance for consultation with deadline for comments on 25th April. https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf

Read More "Draft points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials"

Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

On 28th of April, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published version 3 of their guidance to sponsors on how to manage clinical trials during the COVID-19 (Coronavirus) pandemic. Key changes from v2 (27-03-2020): distributor to trial participant IMP shipment, monitoring, remote source data verification […]

Read More "Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic"

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