Deep Expertise in Protocol Development
Efficient, scientifically rigorous protocols developed by those with direct clinical trial experience provide the biopharmaceutical company with protocols that are executable and enable the data needed for regulatory submission.
We have negotiated with Health Authorities and Regulators across the globe and have first hand experience in translating Health Authority requests and your business needs into protocols that will meet your registration requirements. A senior protocol development team member can even support your FDA and/or Scientific Advice (EMA) program discussion meetings to further ensure that your protocols reflect your scientific needs. The Echelon Protocol Development Team is ready to respond to every protocol need.
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