Deliverables
Report on ISO accreditation readiness
Interim report 2 of patients' recruitment, study implementation and clinical trial monitoring
Interim reports of patients' recruitment, study implementation and clinical trial monitoring
Report the final primary and secondary endpoints results assessments of FIH studyReport the final primary and secondary endpoints results assessments of FIH study
Report on clinicians workshopQuality control plan
Finalized clinical protocol and investigator brochure submitted
Interim report 1 of patients' recruitment, study implementation and clinical trial monitoring
Interim reports of patients' recruitment, study implementation and clinical trial monitoring
Updates to the risk mitigation strategyReport on study initiation and training of clinical sites
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