在首次人类自身免疫研究中实现为期7周的研究启动

Parexel Case Study A U.S. biopharmaceutical company’s innovative autoimmune first-in-Human (FIH)study achieved rapid site initiation through Parexel’s simplified study design,parallel regulatory strategy, and coordinated global-local expertise in a highlycompetitive landscape. Requirements FIH study (78+ healthy volunteers (HV) , 32 atopic dermatitis patients)→high design complexity:Single ascending does (SAD) + multiple ascending does (MAD) + food‑effect cohort for innovativeautoimmune small molecule Hybrid HV + patient design→increased protocol & Investigator’s Brochure (IB) complexity: HigherHuman Research Ethics Committee (HREC) review risk and likelihood of queriesAggressive, non‑standard timeline→zero tolerance for delays: All site start‑up (SSU) activitiesrequired precise alignmentMulti‑vendor ecosystem→interdependent setup risks: Electrocardiogram (ECG), bioanalytical,electronic data capture (EDC) and randomization vendors required synchronized activationGlobal team structure (U.S., Australia, Asia)→high coordination load: Cross‑time‑zone executionincreased communication and decision‑making complexity Approach Split hybrid HV + patient design→simplified study execution: Converted to HV‑only study→reduced protocol/IB complexity and lower HREC query riskParallel Clinical Trial Notification (CTN) + HREC submissions→shortened approval timeline:Eliminated sequential bottlenecks→accelerated regulatory and ethics approvalsStepwise EDC build→staged system readiness: Prioritized initial set‑up to support early study startChina Early Phase team /APAC leadership + Australia operations→aligned global‑local execution:Enabled parallel site selection, PK/PD lab qualification and ethics submission Leveraged established vendor relationships→compressed setup cycles: Accelerated onboardingacross ECG, bioanalytical, EDC and randomization vendorsParallel execution model→synchronized SSU readiness: Early Site Initiation Visit (SIV) planning +coordinated vendor set‑up→avoided downstream delays before first patient first dose (FPFD) Outcome Parallel CTN + HREC strategy→earlier activation:SIV completed ~2 weeks ahead of schedule33% faster on EDC setup→completed in 8 weeks vs. 12 weeks standard, with full edit checksdelivered on time with no timeline impactParallel start‑up model + simplified design→SSU in 7 weeks:~45% faster vs. ~13 weeks standardCoordinated execution→on‑schedule first dosing: FSFD achieved with no safety findings observedIntegrated global–local team model→operational excellence in execution: Cross‑functionalexpertise combined with strong local execution enabled efficient and coordinated global delivery