Clinical Research

BioGenesis Health Cluster Clinical Research Services combines biostatistical advancements, clinical software programming and operations with deep regulatory familiarity. BioGenesis Health Cluster focuses on developing and deploying technology solutions that empower sponsor companies to substantially improve their clinical process efficiencies and outcomes. Built upon collaborations with industry and regulators, BioGenesis Health Cluster trial design, analysis and data management software tools are relied on for their precision and proven ability to speed critical proc

Data Management

CRF Development & Annotation
Data Management plan
Database Development
CRF Tracking
Validation checks
Edit Checks and Query Generation
Coding AE and medications
Integrate lab data
Reconcile AE and SAE
Data Cleaning and Validation
Lock Database
Data Set Transfer

Statistics & Programming

Trial Design & Simulation
FDA/EMA representation
Sample Size Calculation
Protocol Development
Randomization- Adaptive & Traditional
Recruitment Forecasting
Event Monitoring
Independent Statistical Center Support
DMC/DSMB Organization
Statistical Analysis Plan
Statistical Programming

Medical Writing

Protocol Preparation
Clinical Study Report Writing
Submission documents
ISS and ISE Writing
Abstracts and Manuscripts
Investigator Brochures