Biostatistical Services

The FDA shoulders high responsibility for ensuring the protection of public health by assuring the safety, effectiveness and security of drugs, and other biological products. The Pharmaceutical industry produces and markets licensed drugs for medical usage. They are subjected to various laws and regulations in ensuring the patenting, testing and marketing of drugs. The Life Sciences industry is dependent on reliable data to run clinical trials and get quick approvals on drug safety and effectiveness. The role of Biostatisticians has become imperative in delivering appropriate statistics to increase the chances of successful trials, create precise clinical study reports and perform various data monitoring analysis to maintain data safety and integrity.
 
Element’s services aid biostatisticians with access to accurate information that complies with the current regulatory standards. The data can be quickly and readily reported that leads to successful clinical trials and faster drug approvals. We have great expertise in the SAS platform, and our clientele is a testament to our years of experience in delivering successful analysis and reporting on various clinical studies across different therapeutic areas.
 
Biostatistics, Clinical SAS Programming, and Program Management:
 

  • Statistical input to Protocol
  • Sample size Estimation
  • Randomization
  • Development of SAP and Mock TLF shells
  • Statistical section writing for CSR
  • Safety & Efficacy Analysis and Reporting
  • Interim Analysis
  • PK/PD Analysis
  • Exploratory Analysis
  • Meta-Analysis
  • Analysis Dataset (ADaM/Sponsor defined) creation
  • QC of analysis and reporting
  • Integrated Summary Support (ISS/ISE)
  • Integration of data
  • Analysis and Reporting
  • Application development (SAS Programming)
  • SAS Visual Analytics (Authorized SAS partner)
  • SAS installation and administration support (Authorized SAS partner)
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