Endocrinology & Metabolic Disorders

Biomarker-driven endpoints, longitudinal modeling, and PRO strategies for diabetes, obesity, and lipid disorders.

Evidence Generation for Endocrine & Metabolic Programs

We align clinical outcomes with laboratory markers and PROs, building robust models for change over time and clinically meaningful response.

Endpoints & Biomarkers

Diabetes: HbA1c, CGM-derived Time-In-Range (TIR), hypoglycemia events.
Obesity: % weight loss, responder analyses (≥5%, ≥10%), cardiometabolic composites.
Lipid disorders: LDL-C, non-HDL-C, ApoB; risk-based composite endpoints.
Device data ingestion (CGM, pumps) with QC and analysis rules.

Modeling, Estimands & Sensitivity

MMRM, GEE, and mixed-effects models with pre-specified covariates and visit windows.
Intercurrent event handling (treatment changes, rescue) aligned to ICH E9(R1) estimands.
Multiplicity control for multiple time points and endpoints.
MI/tipping-point sensitivity and responder analyses.

Deliverables & Submission Readiness

ADaM aligned to metabolic endpoints with clear derivations and traceability.
TLFs: longitudinal trajectories, responder plots, shift tables, and safety profiles.
Reviewer guides, define.xml, and responses to authority queries.

Accelerate Your Metabolic Portfolio

Partner with Magnus CRO to design endpoints, models, and deliverables that withstand regulatory review.

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