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Clinical Research Services
Clinical Data Management Biostatistics and SAS Programming CDISC and Regulatory Services Drug Safety and Pharmacovigilance Medical Writing Clinical Operations  
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SAS Programming services has evolved over the years, with demand for high-end such as CDISC compliance and usage of ETL technologies to automate standardization processes on the rise. LAXAI has customized solutions including SAS 9, SAS DI Studio, SAS Metadata Server and SAS Drug R&D. Our experience in dealing with problem areas such as data transfer issues between the Data Management and Biostatistics team or issues stemming out of a CRF data element which can lead to ambiguous data capture in a CRF form have made us think big and propose solutions which ensure data standardization and a seamless data interchange across the data lifecycle with SDTM and ODM standards guiding the entire workflow right from CRF design all the way until CRT DDS generation. We provide an integrated solution which addresses the traditional bottlenecks in SAS Programming.
  • Power / Sample size estimation
  • Statistical modeling
  • Protocol and SAP preparation
  • Mock tables and listings
  • Edit check programming for Data Management team
  • Data extraction, transformation and loading to SDTM formats
  • Legacy to SDTM Data mapping and conversion services
  • Analysis dataset generation
  • Validation programming and QC
  • Tables, Listings and Graph generation
  • Interim analysis
  • Statistical Analysis
  • Integrated Summary of Safety and Efficacy
  • Final Report generation
  • CRT DDS and Define.xml generation
LAXAI has established a strategic relationship with SAS Life Sciences in supporting their products. LAXAI is an Authorized Training Provider in India region and provides SAS training customized for the life sciences industry.
 
Engagement Models
 
LAXAI provides flexible and scalable engagement models to manage your Biostatistics and SAS Programming outsourcing.

We propose the offsite model for clients who would like to try outsourcing with LAXAI. The entire team comprising of Project Manager, Biostatistician, QC Programmers and Programmers would work out of our offsite solution center.

Further cost savings could be achieved by using a Blended Offshore model where-in the Project Manager, Biostatistician and QC Programmer would be working out of offsite solution center in NJ and the programming activities could be carried out from our offshore solution center in Hyderabad, India.

These flexible engagement models assure the client of constant communication with the project team, improved efficiencies and cost savings typically ranging between 15% - 40% with guaranteed quality assurance.
 
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