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Whitepaper

USA, UK, EU & China – Decentralized Clinical Regulations Differences

It’s important to note that regulations surrounding DCTs are constantly evolving, and sponsors should consult with regulatory agencies in each country to ensure compliance with current regulations.

Decentralized clinical trials (DCTs) are becoming increasingly popular in the pharmaceutical industry, as they offer many benefits such as reducing costs, increasing patient participation, and providing real-time data. However, the regulations surrounding DCTs vary by country. Here is a brief overview of DCT regulations in the USA, UK, EU, and China.

This Whitepaper highlights:

  • The FDA guidance and recommendations on DCTs
  • The MHRA guidance and recommendations on DCTs
  • The EMA guidance and recommendations on DCTs
  • The NMPA guidance and recommendations on DCTs
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