BIOSTATISTICS

The entire process of hypothesis testing is complex, yet critical to the outcome of a clinical study. 

​

Expert statisticians with years of experience working with the USFDA help you to design a study in order to distinguish correlation from causation and to identify and prevent data manipulation. 

Designing of the analyses to ensure that biases are controlled, and that errors are distinguished and measured as random and non-random, allows valid inferences that protect patient safety and help bring innovative solutions to the market.  

​

At PPCE, we recognize the necessity to integrate the Biostatistics role from protocol development through study monitoring all the way to the clinical study report in a trial.

BIOSTATISTICS SERVICES

• Input to Protocol / Study Design 

• Sample Size Estimation

• Randomization Schedule

• Statistical Analysis Plan (SAP) Preparation 

• Programming of TLF Shells

• PK / PD Analysis

• Creation of Tables, Listings, Figures

• Analysis of Safety, Efficacy Data

• Statistical Report Writing

• Interim and Final Analysis 

THE PPCE ADVANTAGE

• Stakeholder input at planning stages : Biostatistics input at all points of a trial from design to close out allows reliable, high quality analysis.

• Real-time data for better decision making : Strong communication channels and quick information flows allow you to make informed decisions in a timely, cost saving manner.

• Flexibility : Our willingness to meet your requirements means you have the
  flexibility to discover a new requirement or to revisit a decision without inordinately affecting timelines.

• Timeliness: High quality output and on-time delivery - no excuses!