Email
hr@newedgeclinical.com
Comprehensive statistical, programming and regulatory services supporting clinical trials from early development through FDA submission.
Development of clinical trial protocols, power and sample size calculations, randomization schedules and study design. Statistical review of DMP and eCRFs to ensure collected data meets protocol-driven analysis and reporting needs. Development of SAP and TFL shells aligned with the clinical study protocol.
Support across Phase I–IV clinical studies including PK/PD. Services include protocol and SAP development, clinical data management, statistical analyses, NONMEM and PK/PD analysis, CSR development, data validation and FDA submission support.
Firewall-protected interim and DMC environments with independent statistical oversight. Development of SAP, mock TFLs and two analysis sets: pooled sponsor review outputs and masked, unblinded outputs for closed DMC sessions—ensuring treatment blinding integrity.
End-to-end CDISC services including aCRF annotation, SDTM and ADaM specifications, dataset generation, independent validation, Pinnacle 21 checks, Define.xml, Reviewers’ Guides and transport file creation.
SAS and R-based statistical programming for CSR, ad-hoc analyses and publications. Services include independent validation, data quality assessments, reconciliation, dry runs and final FDA-compliant dataset and TFL deliveries supporting NDA submissions.
Comprehensive FDA submission support including NDA, BLA, ISS/ISE, CDISC packages (SDTM/ADaM), eCTD components, DDT, IB and IND submissions.
BIMO package preparation aligned with FDA regulatory expectations including clinical site listings, contracted entity tables, OSI listings, summary-level datasets, Clinsite.xpt, Define.xml and BIMO Data Reviewer’s Guide.
Additional offerings include IT services, clinical project management, scientific research, HEOR, RWE, medical and scientific communications, regulatory and medical affairs, and professional services supporting the full clinical trial lifecycle.