Clinical Research Solutions.

Biostatistics & Programming

Advanced trial design, statistical programming, simulations, DSMB support, and CDISC deliverables. Our core capability and competitive
edge. SAP development, interim/final analyses, DSMB support, CDISC S DTM/ADaM, SAS/R/Python stack.

Biostatistics is at the core of what we do. Our team delivers advanced trial design, statistical programming, and rigorous data analysis to power regulatory decisions. Services include SAP development, simulations, DSMB support, multiplicity controls, and CDISC-compliant datasets. Whether for cardiovascular outcomes trials, orthopedic devices, or spine studies, we provide audit-ready deliverables that stand up to FDA and EMA review.

Clinical Study Design

Adaptive designs, non-inferiority, PROs, RWE integration Well-designed studies create efficient pathways to approval. Nor Consult supports sponsors with time-to-event analyses, non-inferiority strategies, patient-reported outcome (PRO) selection, and real-world evidence integration. Our goal is to maximize regulatory acceptance while aligning with payer and market expectations.

Clinical Epidemiology

With a PhD-level Clinical Epidemiologist on staff, Nor Consult provides sponsors with scientific rigor and population-based insights rarely found in CROs. By integrating epidemiology with our biostatistics and trial design expertise, we help sponsors accelerate development, deliver regulatory-grade evidence, and strengthen postapproval market adoption strategies.

How Clinical Epidemiology Benefits Sponsors

• Optimized Study Design – Precision in protocol development, endpoint selection, and bias control to meet regulatory expectations.
• Actionable Insights – Data interpretation grounded in real-world epidemiology, ensuring trial results are both statistically sound and clinically meaningful.
• Strategic Advantage – Scientifically credible narratives that resonate with regulators, clinicians, and payers.
• Evidence-Backed Marketing – Translating results into real-world and postapproval contexts, driving adoption and market confidence.

Data Management

Full-service EDC builds, query resolution, multi-source data integration, and audit-ready datasets for FDA, EMA, and global regulators.

Data integrity drives credibility. Our data management team delivers full-service EDC builds, database lock, and audit-ready datasets. We specialize in integrating multiple data sources—core labs, registries, RWE—into a single traceable package, ensuring that sponsors are always submission-ready.

Imaging & Core Labs

Trusted partnerships for adjudication and integrated imaging endpoints for submission ready data.

Through trusted partnerships, Nor Consult offers access to imaging core labs and centralized adjudication services. We integrate imaging data seamlessly with biostatistics and EDC systems, ensuring endpoints are analyzed with accuracy, consistency, and regulatory traceability.

Safety Management & Reporting

Independent Safety Assessments

Patient safety is paramount. Contact us today to learn how Nor Consult can support your Independent Medical Safety Monitor (IMSM), Data Safety Monitoring Board (DSMB) and other global independent safety monitoring needs.

Medical Writing & Publications

Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), HEOR analyses.

100+ manuscripts and 1,000+ abstracts published globally, in line with ICMJE and NIH guidelines.