Biostatistics & Statistical Programming Services

Biostatistical Services has always been a key component of Innayat CRO services. Our experienced biostatistics team extends help at all phases of clinical trials from pre-clinical analysis to clinical and post-marketing support to pharma, medical device, food and nutraceutical-based trials. Based on our client’s needs, we customize our solution and present the results in a clear and precise manner. At Guires, we provide support on the following clinical biostatistics services

Statistics play a vital role in clinical trials and in the drug development process-from trial design to protocol development. Statistics is required for specialized study designs (even complex designs like Adaptive Trial Design), therapeutic areas and statistical methods.

We offer a wide range of bio-statistical services from sample size calculation to delivery of fully compliant statistical analysis reports. Our Biostatistics and Programming department is fully compliant with regulatory requirements and has the capability to deliver extensive Biostatistics and Programming projects. Our team ensures successful high-quality delivery by keeping your clinical development program on schedule throughout. Our team remains involved at every stage and works closely with the data management and medical writing team. Our team comprises Biostatistics Lead, Senior Biostatistics, and Many SAS Programmers from entry-level to Senior Level.

Our Biostatistics and Programming Team can manage complex studies by performing in-depth analysis and interpretation of data in different therapeutic areas. We are specialized in managing the following Biostatistics and Programming activities:

• Statistical Input in Protocol
• Determination of Primary and Secondary Endpoints
• Sample Size Calculation
• Preparation of Randomization Plan
• Input in CRF and eCRF Design
• Preparation of Statistical Analysis Plan
• Statistical and SAS programming
• Preparation of Statistical Tables, Graphs, and Listings
• Preparation of Statistical Reports

Our Capabilities are as follow:

• Descriptive statistics
• Sample size estimation and justification
• Statistical methods for protocol development
• Randomization schedule generation and management
• Statistical Analysis Plan development for individual studies
• Programming of Statistical Tables, Listings and Graphs
• Analysis dataset creation
• Interim and final analyses/Support DSMB or DSRB
• Independent QC programming
• Support for marketing
• Exploratory and trend analysis
• Analyses for manuscript preparation
• Patient Profiling
• Patient Narratives