pharmacovigilance process setup ,CDM process setup for IT ,KPO,BPO Sectors ,Complete life cycle process

1. pvconsultant@consultant.com

2.  CDM –Clinical Data Management
 Phamacovigilance
 Real World Evidence –Analytics –
Healthcare,Pharma,Life sciences,Clinical

3.  We offer setup Pharamcovigilance Project
process setup and project execution
 KPO /BPO /IT org stepping into the process of
CDM /PV/ RWE Process setup
 Complete life cycle setup process
 White papers
 Software Implementations required for the
process
 Recruitment for the process
pvconsultant@consultant.com

4.  Data management -Safety
 Signal detection
 Signal evaluation ,Decision Making
 Regulatory ,Actions
 Communicating concerned parties or
stakeholders

5.  Data collection
 Data Validation verification
 Adverse reaction coding
 Coding of drugs
 Assessment- Case causality
 Reporting

6.  Case receipt
 Case process
 Regulatory submission
 Aggregate reporting
 Signal Detection
 Risk assessment

7.  Detection of adverse reactions and
interactions
 Detection of increases in frequency of Known
adverse reactions
 Identification of risk factors and possible
mechanisms underlying adverse reactions
 Estimation of quantitative aspects of
benefit/risk analysis and dissemination of
information needed to improve drug
prescribing and regulation.

8.  We offer setup Pharamcovigilance Project
process setup and project execution
 KPO /BPO /IT org stepping into the process of
CDM /PV/ RWE Process setup
 Complete life cycle setup process
 White papers
 Software Implementations required for the
process
 Recruitment for the process
pvconsultant@consultant.com