1. Biostatistics, Programming & CDISC Compliance

  • Statistical Strategy & Protocol Design: Sample size calculation, randomization, and endpoint selection.
  • Statistical Analysis Plans (SAP): Development of rigorous, defendable SAPs.
  • Statistical Programming & Analysis: Production of all TLFs using SAS/R/Python.
  • CDISC Implementation & Consulting:
    • SDTM & ADaM dataset creation and mapping.
    • Define.xml and SDRG/ADRG generation.
    • Pinnacle 21 compliance checking and remediation.
    • Integrated Summary of Efficacy/Safety (ISE/ISS) support.
  • eSubmission Ready Packages: Complete, compliant data packages for FDA, EMA, NMPA, etc.
Biostatistics
Data Management

2. Data Management & Integration

  • Clinical Data Management (CDM): EDC build (RAVE, Medrio, Veeva, etc.), data cleaning, discrepancy management, medical coding (MedDRA/WHODrug).
  • Advanced Data Oversight: Risk-Based Monitoring (RBM) central statistics, key risk indicator (KRI) dashboards.
  • Data Integration & Warehousing: Handling of complex data (lab, imaging, wearables, genomics) into a unified clinical data warehouse.
  • Database Lock & Archiving: Efficient, audit-ready processes for timely and secure database locks.

3. Real-World Evidence & Advanced Analytics

  • RWE Strategy & Study Design: Retrospective, prospective, and hybrid study designs using RWD.
  • RWD Analysis & Health Informatics: Analysis of EHR, claims, registry, and patient-reported outcomes (PRO) data.
  • Comparative Effectiveness Research (CER) & Safety Surveillance: Post-market studies and pharmacoepidemiology.
  • Data Visualization & Dashboarding: Interactive tools for internal decision-making and external communication.
RWE
RWE

4. Clinical Operations (Powered by Data Insights)

  • Project & Vendor Management
  • Site Management & Monitoring (informed by central data trends)
  • Patient Recruitment & Retention Analytics

5. Regulatory & Medical Writing

  • Regulatory Strategy informed by data and submission standards.
  • CSRs, Protocols, and Summaries crafted to highlight robust data insights.
RWE