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.

John Carlisle, an anaesthetist from England's National Health Service and an editor at the journal Anaesthesia, reviewed more than 500 randomized clinical trials. He had an access to raw data of more than 150 trials. He found that 44% of these trials contained problems such as: impossible statistics, incorrect calculations or duplicated numbers or figures. 26% of the papers was impossible to trust, either because the authors were incompetent, or because they had faked the data.

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.

Turkish Clinical Research Association celebrates 20 May - World Clinical Trials Day.
In 1747, Scottish Ship Surgeon James Lind made an attempt to figure out how to treat scurvy. This trial is now recognized as the first clinical trial and is accepted as International Clinical Research Day on May 20th.

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.

Turkish Clinical Research Association wishes a happy and healthy 2022 without COVID-19...

The European Union’s Health Commission proposed pushing back the deadline for the new medical device regulation (MDR) law to 2028. The deadline for high-risk products will be 2027. and a 2028 deadline for medium and low-risk devices is proposed.