Customized Support Services

As part of your team, we will conduct reach out, qualification and oversee renowned service providers to ensure they are offering solutions tailored to YOUR specific needs.

Our specialized service network covers a wide range of disciplines:

- Regulatory and scientific affairs

· Study design development and sample size estimation

· Regulatory filings

· Protocol and Medical writing
 

- Bioanalytical services

· Method Development and Validation

· Bioanalysis
 

- PK/PD analysis

· Non-compartmental and compartmental analyses

· Modeling and simulation reports

· Predictive analyses and correlation assessments
 

- Data Management

· Database build

· Data Management Plan

· Statistical Analysis Plan and TFLs
 

- Pre-Clinical development

· Lead Optimization

· Toxicology Studies

· Pharmacology and PK/PD assessments

· Dose finding & MTD