Biometrics and data science services

Protocol statistical design, sample size, endpoint strategy, adaptive and Bayesian designs, and regulatory interactions.

• Protocol statistical design
• Sample size calculations
• Endpoint strategy
• Adaptive designs

SAS, R and Python programming, QC programming and automation solutions.

• SAS Programming
• R Programming
• Python Programming
• QC Programming

SDTM mapping, ADaM development, Define.xml, cSDRG and ADRG, with regulatory eSubmissions support.

• SDTM Mapping
• ADaM Development
• Define.xml
• cSDRG

Efficacy and safety TLFs, PK/PD outputs and ISS/ISE support.

• Efficacy TLFs
• Safety TLFs
• PK/PD Outputs
• ISS/ISE Support

Time-to-event analysis connected to endpoint strategy, efficacy outputs and partitioned survival models.

• Endpoint strategy
• Protocol statistical design
• Sample size calculations
• Efficacy TLFs

Propensity score matching, IPTW, IV methods and doubly robust models for observational data.

• Propensity Score Matching
• IPTW
• IV Methods
• Doubly Robust Models

SAPs for clinical and observational studies, built on sound statistical design.

• Protocol statistical design
• Endpoint strategy
• Sample size calculations
• Adaptive designs

CRF design, query management, data cleaning, reconciliation and database lock.

• CRF Design
• Query Management
• Data Cleaning
• Reconciliation

Database build, UAT, edit checks and validation testing on Medidata Rave, Veeva Vault EDC, REDCap and OpenClinica.

• Medidata Rave
• Veeva Vault EDC
• REDCap
• OpenClinica

ETL pipelines, data warehouses, common data models and research-ready datasets.

• EHR
• Claims
• Registry
• Clinical Trial Data

Evidence gap assessment and planning through study design, analytics execution and publication support.

• Evidence Gap Assessment
• Evidence Planning
• Study Design
• Protocol Development

Claims and EHR feasibility, registry evaluation, data source selection and cohort evaluations.

• Claims Feasibility
• EHR Feasibility
• Registry Evaluation
• Data Source Selection

Retrospective and prospective cohort, case-control, cross-sectional and registry-based studies.

• Retrospective Cohort Studies
• Prospective Cohort Studies
• Case-Control Studies
• Cross-Sectional Studies

Which treatment performs best, which population benefits most, and the impact on healthcare utilization.

• Which treatment performs best?
• Which population benefits most?
• What is the impact on healthcare utilization?
• Propensity Score Matching

Diagnosis pathways, treatment patterns, switching behavior, adherence, persistence and disease progression.

• Diagnosis Pathways
• Treatment Patterns
• Switching Behavior
• Adherence

Burden and cost of illness, economic evaluation, outcomes research and utility research.

• Burden of Illness
• Cost of Illness
• Economic Evaluation
• Outcomes Research

Value strategy, evidence planning, payer research, pricing strategy and access optimization.

• Value Strategy
• Evidence Planning
• Payer Research
• Pricing Strategy

Markov, decision tree, partitioned survival and microsimulation models producing QALYs, ICERs and cost-utility results.

• Markov Models
• Decision Trees
• Partitioned Survival Models
• Microsimulation Models

Eligible population, treatment uptake, healthcare costs and resource utilization.

• Eligible Population
• Treatment Uptake
• Healthcare Costs
• Resource Utilization

Value dossiers, HTA submissions, economic models and supporting evidence packages.

• NICE
• CADTH
• ICER
• PBAC

Regulatory writing (protocols, SAPs, CSRs, investigator brochures) and scientific writing.

• Protocols
• SAPs
• CSRs
• Investigator Brochures

Publication strategy, manuscript development, journal submission and congress planning.

• Publication Strategy
• Manuscript Development
• Journal Submission
• Congress Planning