Review capabilities & services
Study types reviewed
Phase IPhase IIPhase IIIPhase IVMedical devicesBiologicsVaccinesRare diseasePediatricOncologyObservational
Review services
Protocol reviewInformed consent reviewRecruitment material reviewAmendment reviewContinuing reviewSafety report reviewFull board review
Therapeutic-area experience
OncologyNeurologyRare diseasesInfectious diseasesCardiovascularImmunologyCell & gene therapyPediatricsVaccines
Illustrative target turnaround by review type — confirm in your service agreement.
Initial protocol — full board30 d
Full board
Statutory ~30-day national REC opinion.
Amendment review20 d
Full board
Expedited / proportionate review14 d
Expedited