TransCelerate’s Open Access Clinical Study Report (CSR) Template
In November 2018, TransCelerate Biopharma - an alliance among some of the world’s prominent biopharmaceutical
TransCelerate’s CSR template was developed using the two “well-known standards” - ICH E3 and CORE Reference (www.core-reference.org). The EMWA AMWA CORE Reference development team was not involved in the TransCelerate CSR template development work.
Read our Press Release on TransCelerate’s CSR template and use of CORE Reference in its development.
EMWA Past President, EMWA Fellow; Director, Sam Hamilton Medical Writing Services Limited
EMWA Past President, EMWA Fellow; AMWA Past President, AMWA Fellow; Principal, MedSciCom, LLC
PhUSE White Paper: Clinical trial transparency and disclosure: A global view
This excellent PhUSE white paper provides a snapshot of the current clinical trial transparency and disclosure arena and is a treasure trove of relevant references, guidances
Impact of EMA Relocation to Amsterdam on RPD Activities
Read this 23-January-2019 update on EMA’s relocation to Amsterdam. Note that in Annex 1 - in which EMA summarise their