Life Sciences Practice
The life sciences industry today demands flexible solutions to expedite drug discovery while at the same time reduce cost for new drugs.

Wipro Life Sciences BPO offers process based services for a broad range of therapeutic areas in CDM, data analytics, CPO and pharmacovigilance to facilitate and expedite the regulatory submission, acceptance and renewal.

Life Sciences Services

• Clinical Data Management Services
  
• Data Analytics Services
  
• Pharmacovigilance

Clinical Data Management Services
Wipro provides a full range of Clinical Data Management (CDM) services to fit your clinical trial needs - from individual stand-alone service to full functional outsourcing of large groups of studies.  

Wipro’s goal is to transform raw data into consistent, accurate, reliable and meaningful trial output in full compliance with regulatory guidelines. Wipro assures to reduce the time between Last Patient Last Visit (LPLV) and the database lock while meeting the quality standards. Wipro can manage clinical trial data remotely in a FDA / EMEA compliant secure environment. Wipro’s CDM solution framework has well-defined metrics for paper-based and automated trials that enable faster decision-making.

Services

• Case report form (CRF) design
  
• Database design and study setup
  
• 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

Data Analytic Services
Wipro provides methodological and analytical expertise to ensure optimal study design, statistical analysis, interpretation and reporting of clinical trials. It also enables you to operate side by side with CDM and clinical research to ensure quality, validity and integrity of the results.

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

Pharmacovigilance
Global regulatory agencies are mandating a proactive risk management approach for sponsors through new initiatives, regulations and guidance. Current regulatory approval and post marketing surveillance process are under public and professional scrutiny to ensure enough is being done to address patient safety.

Wipro BPO takes a partner approach with the sponsors to facilitate information sharing, monitoring and reporting services.

Services

• Drug information services - providing information to consumers and healthcare professionals on dosage, safety, side effects, interactions, storage etc.
  
• Product complaint management - record from users and maintain a complaint database of all relevant  product complaint data such as lot number and expiration date
  
• ADE monitoring and reporting - record adverse events and maintain safety database