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HEALTHCARE AND LIFE-SCIENCES
Clinical Data Management Services

Life-sciences organization are today differentiated based on their ability to expedite drug development process and their ability to cut the costs of clinical trials.

Wipro understands criticality of Clinical data management, in a clinical trials process and the need to ensure regulatory compliance and controlling the cost associated with managing the clinical trial data. Wipro therefore brings together its best team to meet Life-Sciences organizations needs in process optimization and business process support services to provide a complete array of solutions and services in clinical data management space. The team develops uniquely tailored solutions to cost effectively meet requirements of a single trial or requirements for complete outsourcing of large group of studies.

Wipro’s goal is to transform raw trial data into consistent, accurate, reliable and meaningful trial output in full compliance with regulatory guidelines. Wipro assures reduction of time between Last Patient Last Visit (LPLV) and the database lock while meeting the highest quality standards. Wipro can manage clinical trial data remotely in a FDA / EMEA compliant secure environment or set up an offshore CDM centre to cater to your exclusive needs based out of an offshore location. Wipro provides services in following areas

Services

Case report form (CRF) design

Data entry and verification – from the following sources
  • Paper / EDC / fax / voice / phone
Data validation and query resolution: Queries are available online for remote access and rapid query turnaround
Medical coding with MedDRA and other dictionaries
Database integration across protocols, including integration of legacy data and standardizing with new coding dictionaries

Wipro provides methodological and analytical expertise to ensure optimal study design, statistical analysis, interpretation and reporting of clinical trials.

Statistical Services

Statistical analysis plan design

Sample size calculations
Randomization schedule design
Interim analysis
Exploratory analysis and statistical modeling for efficacy and safety evaluation of drugs
Statistical support for publications and post marketing analysis
Integrated analysis of efficacy and safety

SAS Programming Services

Creation of analysis database

Edit checks and database clean-up
Program summary tables, listings and graphs



 
 
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  CASE STUDIES
Development of an outpatient pharmacy system for a healthcare IT company
Re-engineering an inpatient pharmacy application for healthcare IT company.
  More case studies
  IDEAS
Parallel implementation of biological software tools with NCBI’s blast as an example to achieve "load balancing"
HIPAA and clinical research
  More ideas

 
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