Biostatistics and Statistical Programming

shape
shape
shape
shape
shape
shape
shape
shape

CDISC Services

Mudhra Software Services specializes in standardization of clinical trials data in compliance with CDISC data standards or sponsor defined standards. With our metadata driven standardization approach our customers are guaranteed to receive quality deliverables in the shortest possible time with significant cost savings.

We Do:
  • Conversion of the on-going or legacy trial data into CDISC SDTM data standards
  • Conversion of analysis data per CDISC ADAM data standards
  • Define.xml creation/validation services as per define.xml 1.0 and 2.0 specifications
  • CRF annotation and reviewer’s guide development
  • Edit check Programming and Validation
  • Laboratory and Vendor Data reconciliation
  • Safety Data Management and Reconciliation
  • Onshore and Offshore Clinical Data Management services
Mudhra Advantages:
  • Flexibility to adhere either to the Client SOP or Internal SO
  • Robust data security and quality management practices

CDISC Services

Our experienced Statisticians and Clinical SAS programmers help our customers in the analysis of clinical trials of all types including parallel, cross over, multi-phase to pharmacokinetics. Our Statisticians and SAS programmers are committed to follow SOPs and ICH guidelines.

We Do:
  • Interim analysis offered withunblinded statistical support and advice
  • PK/PD analysis by modelling the relationship between exposure and response using non-linear models and non-linear mixed effect modelling
  • ISS/ISE – Support for the integration of safety and efficacy data provided prior to the regulatory approval
  • Pre-clinical studies support that ensures fulfilment of study objective
  • Protocol inputs including clinical study design, sample size calculations consultancy advice
  • Statistical Analysis Plan and TLF shells provided
Mudhra Advantages:
  • We reduce Risks
  • We accelerate timelines and reduce the turnaround time for results
  • We improve the quality of submission through our robust quality management practices