Services

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Clinical Data Analysis and Reporting: 

Our expert consultants work on clinical research data to create the value-added datasets as per sponsor’s study need. Production and validation activities are performed to support timely completion of Clinical Trial projects and submission to regulatory authorities. 

Following activities are completed as per project timelines:  

• Support Phase I, II and III clinical trials 
• CDISC Data Mapping (SDTM &ADaM) 
• Edit checks to identify potential data issues and outliers 
• Pinnacle 21 validation 
• Pooled Data Analysis & Reporting 
• Safety (ADR) Reporting 
• Patient Profiles & Data Cleaning Reporting 

Statistical Programming: 

Our SAS and statistical programming team generates Tables, Listings and Graphs for sponsor studies. We have experts that understand the input standard datasets, make necessary changes as per changing specifications, produce data displays that are a perfect match with required mock shells, and use their rich experience to make any required updates quickly. Our consultants are well equipped to identify any risks ahead of time and provide right solutions in timely manner. 

• We provide following services exclusively with SAS® software:   
• TLF production Programming 
• TLF validation 
• ISS and ISE report generation 
• AdHoc requests 
• FDA queries support 
• Work on PK | PD Calculations 
• Health Economics Outcomes and Research (HEOR) programming and analysis 
• Regulatory Submission support 
• Database lock and Final CSR reporting 

Biostatistics consulting 

We provide a range of statistical support services as mentioned below:

• Statistical consulting 
• Statistical programming 
• Statistical interpretation and reporting