Our Services

Specialized support across the drug lifecycle

Lambros provides biostatistical consulting and statistical programming services tailored to your study needs, timelines, and regulatory expectations.

Core

Biostatistics & Statistical Programming

End-to-end programming and analysis support for clinical studies — from planning to regulatory-ready outputs.

  • • SAP support & analysis
  • • TLFs and CSR support
  • • Integrated analyses
  • • Submission package readiness

Standards

CDISC SDTM / ADaM Implementation

Standardization support aligned to CDISC models with traceability and validation readiness.

  • • SDTM / ADaM conversion
  • • define.xml support
  • • Reviewer’s guides
  • • Validation & QC support

Outputs

Tables, Listings & Figures (TLFs)

High-quality TLF generation and QC workflows supporting clinical and regulatory reporting.

  • • Output shells & programming
  • • Consistency checks
  • • CSR-ready formatting
  • • Review cycle support

Studies

BA/BE & PK/PD Statistical Support

Statistical analysis and reporting support for BA/BE and PK/PD studies with strong documentation.

  • • Study analysis support
  • • PK parameter summaries
  • • Comparative statistics
  • • Report-ready outputs

In-Vitro

In-Vitro Statistics (IVRT / IVPT)

In-vitro analytics and statistical comparisons supporting formulation and performance evaluation.

  • • IVRT / IVPT analysis
  • • Dissolution comparisons
  • • Stability trend analytics
  • • Clear reporting outputs

Quality

QC, Review & Documentation

Structured QC and review workflows that help reduce rework and improve submission confidence.

  • • SOP-based checks
  • • Traceability support
  • • Versioning & review cycles
  • • Clean documentation

How we work

A simple engagement flow

Clear scope, strong execution, and consistent communication from start to delivery.

01

Requirement

We understand scope, timelines, standards and review expectations.

02

Plan

We share approach, milestones, roles and deliverable structure.

03

Execute

Programming and analysis with SOP-based checks and tracking.

04

Deliver

Final outputs with documentation and review cycle support.

Ready to discuss your requirement?

Share your scope and timelines — we’ll respond with a structured approach.