Biometrics-driven CRO delivering precision, insight, and innovation in every clinical trial.
Magnus CRO is a biometrics-focused Clinical Research Organization delivering accurate, compliant, and timely clinical trial data. Our SOP-driven approach ensures data integrity, regulatory alignment, and operational excellence at every phase of development.
Rigorously designed analyses and statistical plans to meet regulatory scrutiny.
Aligned to ICH-GCP, 21 CFR Part 11, and ALCOA+ with inspection-ready data.
Clear milestones, proactive risk management, and responsive communication.
CRF/eCRF design, edit checks, discrepancy management, and database lock.
MedDRA & WHO Drug coding, consistency review, and reconciliation.
Statistical planning, SAP authoring, interim & final analyses.
CDISC SDTM/ADaM datasets, TLF generation, and validation.
Safety case handling, SAE reconciliation, and signal detection.
Protocols, CSRs, reviewer guides, and regulatory responses.
RECIST/irRECIST, survival endpoints, oncology-focused analytics.
DMD, MG, ALS — functional & digital endpoints, longitudinal models.
Clinical + microbiology endpoints, PK/PD integration.
Composite indices, immunogenicity integration, estimands.
QTc evaluation, MACE composites, adjudication traceability.
Biomarker-driven endpoints and longitudinal modeling.
Representative results from recent engagements. Sponsor details withheld to protect confidentiality.
Reduced data cleaning cycle time by 30% through proactive edit-check design and streamlined discrepancy management.
Delivered fully reconciled MACE-adjudicated datasets ahead of the sponsor's interim analysis deadline.
Supported a clean database lock across 40+ sites with zero critical findings at sponsor audit.
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Magnus CRO
1910 Pacific Ave, Ste 2000
Dallas, Texas-75201
Email: info@magnusinfotek.com
Phone: +1 (727) 916-7754
