NEWS

European CRO Federation is organizing the 7. European Clinical Research Conference on 19-20 February in Prag.

EMA’s human medicines committee (CHMP) suspended the marketing authorisation of several biosimilar generic medicines tested by Synchron Research Services and Synapse Labs.

A critical medicine is identified by combining two criteria, the seriousness of the disease they target and the availability of alternative medicines. The Union list of critical medicines identifies medicines for human use for which continuity of supply in the EU is a priority and shortages should be avoided. The obligations for marketing authorisation holders and national competent authorities that can be taken at EU level, are yet to be defined.

EMA has initiated a review of medicines for which studies were conducted by Synapse Labs Pvt. Ltd.. This followed a GCP inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.

EU DARWIN is a coordination data center to collect real world data on medicines and vaccines...

FDA has issued a warning letter to a researcher following an inspection conducted at the site.

A survey from the European CRO Federation (EUCROF) was conducted between July and September 2022. Seventy-seven% of the participating CROs stated that the COVID-19 pandemic caused changes in their internal organization. The discontinuation or slowing down of recruitment of new trial participants, cancellation or postponement of on-site monitoring visits, temporary halt of the trial at some of all trial sites, and cancellation of patient visits were the main problems. Şebnem Yaşaroğulları from Tu

This version focuses on the use of new technologies especially in monitoring, data management and responsibilities.

After legislation signed by President Joe Biden, U.S. Food and Drug Administration (FDA) will not require animal tests before human drug trials. This is applicable to drugs and biologicals.

As the number of endpoints analyzed in a single trial increases, the likelihood of making false conclusions about a drug’s effects with respect to one or more of those endpoints becomes a concern if there is not appropriate adjustment for multiplicity. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well-recognized statistical methods for managing multiplicity within a study in order to control the chance of making