Highly Competent Biometrics Group

The Biometrics group at Lotus Labs is highly competent to support clients at all Clinical Trials phases. Our Biometrics services portfolio are used by pharmaceutical, biotechnology, device, diagnostic and research organizations. Biometrics services at Lotus include protocol writing, statistical analysis and report writing. At Lotus, the Biometrics is well equipped with the latest softwares like Win NonLin and SAS(SDMS & MED X view).

Clinical Data Management

Lotus Labs provides comprehensive Data Management services in bio-equivalence and Phase I-IV Clinical Trials. Our goal is to transform raw data into consistent, accurate and reliable trial outputs in compliance with regulatory guidelines. As a dedicated partner for the success of the client’s Clinical Development program, our Biometrics group focus to expedite the regulatory submission process and shorten timelines through innovative thinking and unflinching commitment to quality.

With capabilities to manage multi-centric studies, for domestic and global requirements in different therapeutics areas, the varied services of our Biometrics portfolio at Lotus Labs are used by pharmaceutical, biotechnology, device, diagnostic and research organizations.

Database Programming

  • CRF Design (paper & electronic)
  • CRF Annotation
  • Database Programming
  • Validation Checks
  • Metadata Repository Management

Data Management

  • Data Acquisition
  • Data Reconciliation
  • Discrepancy Management
  • Medical Coding (MeDRA & WHODD)
  • Database Lock
  • Data Extraction for Reporting

Pharmacokinetic & Pharmacodynamic Studies
PK Center of Excellence

  • Sampling Point Estimation
  • Technical Document Review
  • PK/PD Query Resolution
  • PK/PD Subject Matter Expert
  • Pharmacokinetic support across study engagement

PK/PD Reporting

  • SDMS Data Extraction
  • PK Data Analysis
  • PK Summary Reporting

Biostatistics
Biostatistics Center of Excellence

  • Randomization
  • Sample size estimation
  • Trial Design Inputs
  • Statistical Analysis Plan
  • Statistical Analysis
  • Biostatistics Subject Matter Expert

Statistical Reporting

  • TLF Programming
  • CDISC Data Mapping (SDTM & ADaM)
  • Clinical Data Repository
  • Pooled Data Analysis & Reporting
  • Safety (ADR) Reporting
  • Patient Profiles & Data Cleaning Reporting