Notifying Bodies have been vocal on the need for clinical studies to be more patient-centric and diverse. Technology can help capture the patient voice.

A central technology platform for global regulatory submissions can help pharma companies decrease timelines, ensure consistency, and maximize ROI. Learn more.

EU Clinical Trials Regulation (CTR) is mandatory for any initial submission of clinical trials with investigational medicinal products. Are you ready?

Annex VI from EU CTR No. 536/2014 covers changes in the labeling requirements for investigational medicinal products (IMPs). Learn more about labeling impacts.

The pharmacovigilance process can be automated to reduce manual burdens on safety teams. Learn about the ways that AI and automated systems can be beneficial.

While electronic labels for investigational medicinal products aren't required by the EU CTR, sponsors should be prepared given their numerous benefits.

Medicare providers should understand their beneficiaries’ demographics and work to identify gaps in communication during open enrollment season.

Key takeaways from a conversation with experts in life sciences on the lack of diversity in clinical trials, and what companies can do to take action.

Plain language summaries of clinical trial results are a critical tool for communicating research information to general audiences. Learn about key requirements.

How pharmaceutical organizations and CROs can connect and engage with diverse patients to increase inclusivity in clinical trials

Protecting IP for life sciences start-ups is a must, as IP is one of the most valuable assets. Consider these four key IP protection strategies for start-ups.

Using call center services can help sponsors recruit more diverse patient populations for clinical trials and maximize the impact of patient engagement and retention.