Confidence Beyond Compliance

PharmaLex is specialized in the development and analyses of innovative clinical trials to maximize the probability of success and the outcome. We use a blend of expertise ranging from Bayesian statistics, pharmacometry and scientific programming to develop by means of intensive simulations cost-effective clinical trials, including adaptive designs and analyses methods. We also produced the highest quality reports (TFLs) and contribute to the study reports and publications.

Our services include:

Protocol and SAP development

  • Methodological support and contribution
  • Evaluation and optimization of clinical end-points
  • Power and optimization using Clinical trial simulations
  • Development of wide range of Adaptive designs
  • Advanced Bayesian statistics
  • Meta-analyses and MAP approaches for prior elicitation

Contribution to CSR and submission

  • Writing and review of CSR
  • Participation to meetings with regulatory bodies

Pediatric development, rare and orphan disease

  • Specialized in rare disease
  • Use of historical data
  • Development of optimized designs with limited data

Biomarker qualification

  • Expertise in bioassays
  • Advanced simulations for design optimization

Analyses of complex data and signals

  • Modeling of PET-scan
  • Modeling of EEG and ECG data

Pharmacovigilance and recruitment

  • Signal detection
  • Bayesian models for efficient Signal detection methodologies
  • Modeling and prediction of recruitment of patients

Programming

  • SAS Programming, CDISC/SDTM/ADAM
  • Production of TFLs for CSR
  • Including NCA PK reporting

JMP-Clinical

  • Training for use and development using JMP-Clinical
  • Applied Risk Based Monitoring using JMP-Clinical