Element’s robust biostatistical services allow you to analyze the accurate information that will endure the strict scrutiny of the regulatory authorities. Element provides biostatistical & statistical programming services to its clients encompassing the entire clinical development lifecycle – protocol development, study design, statistical analysis and regulatory submission.
Element enables organizations to implement and manage the data integration process irrespective of the data source. We assist you in making a quick impact analysis of the potential changes that may affect the overall data integration process while adhering to SDTM and ODM standards. Adhering to data standards and by managing data integration, Element ensures orderly monitoring of the entire workflow right from CRF design all the way till CRT DDS generation. Our biostatistician/statistical programming team’s platform knowledge and skills will enable organizations to analyze and report on diverse clinical studies across various therapeutic areas.
To establish the integrity and proper interpretation of clinical trial data, it is imperative that organizations maintain proper communication between statisticians and data management teams. Element’s services have been designed to provide optimal value for various clinical trials by ensuring that quality data is provided to statisticians to enable them to generate different business insights based on business requirements.
Our focus is to add value with our expertise to derive enhanced results and outcomes for your business. Our experienced team offer services that stay in compliance with the current industry standards and regulatory guidelines.
Element is up-to-date with evolving industry standards, changes in regulatory requirements and evolution of new technology/applications in the Lifesciences industry.
Our client experiences include different projects spanning multiple therapeutic areas across the drug development lifecycle. Our focus on innovation, automation and process optimization, combined with the ability to deliver customized solutions, has made us gain recognition as a trusted partner by pharmaceutical companies and CRO’s to deliver high quality analysis.
Our Service Offerings:
- Pre-clinical studies assistance
- Statistical Analysis Plan to expand the chances of a successful trial
- SAS Programming approach for better efficiency while generating output
- High precision and rich quality clinical study reports
- Statistical support in the form of data-safety monitoring and interim analysis
- Meta-analysis to help your business in adopting best statistical methods
We provide integrated solutions that address the traditional bottlenecks in SAS Programming:
- Statistical modeling
- Protocol and Statistical Analysis Plan (SAP) preparation
- Edit check programming for data management teams
- Data extraction, transformation and loading to SDTM formats
- Legacy to SDTM data mapping and conversion services
- Validation programming and QC
- Interim analysis and Statistical Analysis
- Integrated Summary of Safety and Efficacy