News

Cromos Pharma on the upcoming implementation of EU Clinical Trial Regulation

The long-awaited European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will come into effect in early 2022. The CTR is intended to improve the submission and review processes for clinical trials via a centralized portal. In recent weeks, the European Medicines Agency (EMA) has confirmed that the clinical trial EU Portal and Database, the key component of the Clinical Trial Information System (CTIS), is complete and proposed a go-live date of 31 January 2022. In this article Cromos Pharma looks forward to the full implementation of the CTR and explores how it will affect the conduct of clinical trials in the EU.

What will the upcoming Clinical Trial Regulation mean for the conduct of trials in the EU?

The long-awaited European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will come into effect in early 2022. The CTR is intended to improve the submission and review processes for clinical trials via a centralized portal. In recent weeks, the European Medicines Agency (EMA) has confirmed that the clinical trial EU Portal and Database, the key component of the Clinical Trial Information System (CTIS), is complete and proposed a go-live date of the 31 January 2022. In this article Cromos Pharma looks forward to the full implementation of the CTR and explores how it will affect the conduct of clinical trials in the EU.

World Hepatitis Day and the role of clinical research

Wednesday 28 July is World Hepatitis Day. Hepatitis is an inflammation of the liver, most commonly caused by viral infection. One of the world’s leading causes of death, viral hepatitis kills as many people worldwide as HIV/AIDS, malaria or tuberculosis. In 2019, WHO estimated that Hepatitis B and C caused the deaths of 1.3 million people. In this article we look at progress made in clinical research and its ongoing role in the efforts to eliminate hepatitis.

Decentralized Clinical Trials: Are they here to stay?

Decentralized clinical trials (DCTs) have been central to the continuation of vital clinical studies throughout the COVID-19 pandemic. Previously the uptake of decentralized models has been slow, but the pandemic changed this. There is now consensus among industry leaders that DCTs are here to stay and may have a central role in advancing research especially in rare diseases. In this article we look at the benefits and challenges of DCTs.

Cromos Pharma's US BDD on COVID's impact on clinical research and recover for clinical trials sector

As the clinical trials sector begins to recover from the impacts of the COVID-19 pandemic, Cromos Pharma’s US BD Director, Nicole Brenna, discussed how her interactions with clients have shown the extent to which the industry was affected. She also talked about how the pandemic accelerated adoption of decentralized/virtual trials and other technologies. Finally, she talked about client priorities now as the industry recovers. Read our Q and A here.

Cromos Pharma highlights Sarcoma Awareness Month

This July, Cromos Pharma is highlighting Sarcoma Awareness Month. Sarcomas are rare malignant cancer tumors that start in the bones and soft tissues. The most common type of sarcoma is soft tissue sarcoma. Four out of five sarcomas occur in soft issues. Over half of these are found in the leg but sarcomas can occur in any part of the body.