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Pharmacovigilance Market Dynamics and Service Provider Benchmarking

  • October 2014
  • -
  • Industry Standard Research
  • -
  • 135 pages

Data collected by ISR suggest that a large portion of pharmacovigilance activity is and will continue to be outsourced to CROs, niche providers, and business process optimization companies.

The information in this report is valuable to sponsors as a means of making more informed outsourcing decisions, and it provides vendors with data regarding what sponsors are looking for in terms of pharmacovigilance service offerings and capabilities.

How you can use this report:

Study Sponsors

- Make a more informed purchase of Pharmacovigilance services by understanding which service providers best fit your company’s needs
- Broaden your CRO evaluation list by accessing peer-based service quality ratings across critical attributes
- Pinpoint potential delivery concerns early in a CRO relationship/ evaluation in order to develop proactive strategies to address potential gaps

Pharmacovigilance Service Providers

- Uncover your own — and competitor —delivery strengths and weaknesses
- Design messaging to tout your company’s strengths
- Compete more effectively by understanding buyers’ selection criteria and outsourcing trends

Table Of Contents

Pharmacovigilance Market Dynamics and Service Provider Benchmarking
Table of Contents

Copyright and Usage Guidelines 6
Methodology 7
Data Collection 7
Sample Source 7
Geography 7
Sponsor Type 7
Pharmacovigilance Providers Profiled 8
Introduction 9
Respondent Demographics and Qualifications 11
Executive Summary 14
Breakdown of Pharmacovigilance Spending 16
Case Processing Spending 17
Regulatory Reporting Spending 18
Benefit-Risk Management Spending 19
Outsourcing Trends 20
Percent of Companies Outsourcing and Using Preferred Providers 21
Use of a Single Pharmacovigilance Service Provider 22
Outsourcing of Specific Pharmacovigilance Services 23
Most Important Capabilities of Outsourcing Vendors 24
Provider Rankings 25
Large CROs 27
Mid-size CROs 28
Niche Safety/PV Providers 29
Business Process Optimization Providers (BPOs) 30
Attribute Scores by Vendor 31
Analytical Resources 32
Benefit-Risk Management 33
Case Management Capabilities 33
Low Cost 34
Global Reporting Capabilities 34
QPPV Capabilities 35
Quality Management 35
Regulatory Compliance 36
Report Writing 36
Reporting Speed/ Turnaround Time 37
Resource Management/ Staff Turnover 37
Signal Detection 38
Use of Drug Safety Databases 39
Drug Safety Database Use - Past 12 months 40
Database Structure Preference 41
Attribute Scores by Safety Database 42
Low Cost 43
Customer Care (call centers, help line, etc) 44
Data Visualization Capabilities 44
Ease of Use 45
Electronic Exchange Capabilities 45
Global Capabilities (eg ability to use the same database in multiple geographic markets) 46
Integration Capabilities 46
IT Services 47
Personalization and Configurability Options 47
Quality of Clinical Data 48
Quality of Post-Marketing Data 48
Reporting Capabilities 49
System Speed/ Page Loads 49
Use of Social Media 50
Utilization of Social Media Channels 51
How Social Media will Impact Pharmacovigilance Budget 52
Study Data 53
Use of Pharmacovigilance Services 54
Source of Adverse Event Reports 54
Pharmacovigilance Activity by Phase 55
Breakdown of Current and Future Pharmacovigilance Activities 56
Trends in Spending 57
Breakdown of Case Processing Spending by Provider Type 57
Breakdown of Regulatory Reporting Spending by Provider Type 58
Breakdown of Benefit-Risk Management Spending by Provider Type 59
Outsourcing Behavior and Experience 60
Percent of Companies Outsourcing Pharmacovigilance Services 60
Location of In-house Pharmacovigilance Activities 61
Location of Outsourced Pharmacovigilance Activities 62
Activities Outsourced 63
Use of Preferred Providers 64
Number of Preferred Providers 65
Anticipated Use of Preferred Providers 66
Anticipated Number of Preferred Providers 67
Use of a Single Pharmacovigilance Service Provider 68
Outsourcing of Specific Pharmacovigilance Services 69
Most Important Capabilities of Outsourcing Vendor 70
First Pharmacovigilance Providers to Come to Mind (Unprompted) 71
Leaders in the Pharmacovigilance Field 72
Providers Likely to be Asked for Proposals 73
Familiarity with Company Service Provider Offerings 74
Familiarity with Company Service Provider Offerings (Continued) 75
Experience Using Particular Providers 76
Provider-Specific Attribute Performance 77
4g Pharmacovigilance 77
Accenture 78
Aptiv Solutions 79
Cerafor 80
Chiltern 81
Clinquest 82
Cognizant 83
Covance 84
DSA - Drug Safety Alliance 85
ICON 86
iGate Patni 87
INC Research 88
inVentiv Health Clinical 89
IRW 90
Kinapse 91
Mapi 92
Medpace 93
Optum Insight 94
ORION 95
PAREXEL 96
Pharm-Olam 97
PharSafer 98
PPD 99
PRA 00
Premier Research 101
PrimeVigilance 102
PROSAR Pharmacovigilance 103
Quanticate 104
Quintiles 105
RTI Health Solutions 106
Sciformix 107
SGS Life Sciences 108
Symogen Pharmacovigilance 109
Synowledge 110
Tata 111
UBC 112
ZEINCRO 113
Drug Safety Database Experience 114
Drug Safety Database Use - Past 12 Months 114
Database Structure Preference 115
Database-Specific Attribute Performance 116
In-house Developed Database 116
Aris Global ARISg 117
Drug Safety Alliance 118
EudraVigilance 119
GCA Software Services 120
Oracle Argus Safety 121
SAS 122
VigiBase 123
Adaptation to Change 124
How Social Media will Impact Pharmacovigilance Budget 124
How Companies are Making Pharmacovigilance Services Less Manual 125
Current Use of Social Media 126
Utilization of Social Media Channels 126
Demographics and Responsibilities 127
Type of Company 127
Decision Making Responsibilities 128
Visibility Within the Organization 129
Management Responsibility 130
Study Phase Responsibility 131
Job Title 132
Location of Office and Corporate Headquarters 133
QPPV Certified 134
About Industry Standard Research 135

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