Review capabilities & services
Study types reviewed
Phase IPhase IIPhase IIIPhase IVMedical devicesCombination productsBiologicsCell & gene therapyVaccinesRare diseasePediatricOncologyObservationalDecentralized trialsDigital health
Review services
Protocol reviewInformed consent reviewRecruitment material reviewAmendment reviewContinuing reviewSafety report reviewEmergency reviewExpedited reviewFull board reviewSingle IRBCentral IRB
Therapeutic-area experience
OncologyNeurologyRare diseasesInfectious diseasesCardiovascularImmunologyCell & gene therapyPediatricsVaccines
Illustrative target turnaround by review type — confirm in your service agreement.
Initial protocol — full board7 d
Full board
New protocol reviewed at convened full-board meeting.
Expedited review5 d
Expedited
Minimal-risk studies & minor changes.
Amendment review4 d
Expedited
Protocol & consent amendments.
Continuing review7 d
Full board
Annual / periodic continuing review.
Emergency / safety review2 d
Expedited
Urgent safety reports & emergency use.