全球结核病研究速度与卓越相匹配

Parexel Case Study Accelerated Site Initiation Visits (SIV) and achieved top global enrollment performancethrough a proactive Regulatory/Ethics Committee strategy and optimized operations. Requirements Despite late release of the final protocol and all 10 ICF versions, Parexel team was required to: Deliver first SIV within ~5 monthsunder an accelerated start‑up timeline.Activate four Philippine sites, including one inexperienced site with no Institutional Review Board(IRB) in place, requiring an oversight solution.Navigate dual ethics review:Local Ethics Committee (LEC) + Central Ethics Committee (CEC) /Single Joint Research Ethics Board (SJREB).Coordinate a high‑complexity global vendor program(~40 vendors incl. AI‑based chest X‑rayanalytics). Solution Strategic Regulatory / Ethics Committee (EC) approach:proactive submission strategy to supportsubmission of available documents, paralleled by contingency preparation. Optimized ethics pathway: Secured early approvals from LEC first.Ensured timeline control with follow‑on CEC submission. IRB enablement for inexperienced site:facilitated participation of the inexperienced site throughoversight arrangement with an experienced site’s EC. Paralleling workstreams to reduce dependency:mitigated risks by proactively managing crossdependencies: esp. AI‑enabled diagnostics and global lab workflows with global vendors, site start‑up(SSU), clinical operations, medical, etc. Results Outstanding performance in one of the most complex MDR‑TB studies Top‑enrolling country globally– 16 randomized patients as of Mar 2026.LEC approvals in 4 months– vs. 5.5‑month average.SIV in 4.5 months– vs. 6‑month average.FPI (First Patient In) in 4.8 months– demonstrating strong site readiness.A repeatable SSU modelfor future Philippines studies, leveraging LEC –—> CEC sequencing and IRBenablement for studies with more than three participating sites.