Protocol Development

What is a clinical study protocol?

The protocol is a blueprint clinical trials follow to ensure participant safety and the integrity of the data collected in the study. The protocol details a clinical study’s objectives, methodology, types of people that will participate in the trial, schedule of tests, etc.

Why does my study need a protocol?

All clinical studies are required to follow protocols that are established by the sponsor. Clinical trials conducted under an IND or IDE cannot begin without a protocol.

How can I ensure that my study’s protocol complies with regulations?

Regulatory Specialists has years of experience helping companies develop protocols that adhere to all the proper regulations and cover all integral goals and aspects of their clinical studies.