Pooja Phogat



EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for Sponsors

May 22, 2018

From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.

Optimal Strategies for Compliance with EMA Policy 0070 on the External Publication of Clinical Data

March 20, 2018

With the EU’s new General Data Protection Regulation coming into force in May this year, the impetus for life sciences firms to cement their data management strategies has increased.