TABLE OF CONTENTS
1 INTRODUCTION 54
1.1 OBJECTIVES OF THE STUDY 54
1.2 MARKET DEFINITION 54
1.3 OVERVIEW OF GLOBAL DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET 54
1.4 LIMITATIONS 55
1.5 MARKETS COVERED 56
2 MARKET SEGMENTATION 59
2.1 MARKETS COVERED 59
2.2 GEOGRAPHICAL SCOPE 60
2.3 YEARS CONSIDERED FOR THE STUDY YEARS CONSIDERED FOR THE STUDY 61
2.4 CURRENCY AND PRICING 61
2.5 DBMR TRIPOD DATA VALIDATION MODEL 62
2.6 MULTIVARIATE MODELLING 65
2.7 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 66
2.8 DBMR MARKET POSITION GRID 67
2.9 VENDOR SHARE ANALYSIS 68
2.10 SECONDARY SOURCES 69
2.11 ASSUMPTIONS 69
3 MARKET OVERVIEW 70
3.1 DRIVERS 72
3.1.1 INCREASING NUMBER OF CLINICAL TRIALS 72
3.1.2 GROWING NUMBER OF CONTRACT RESEARCH ORGANIZATIONS 74
3.1.3 INCREASE IN R & D EXPENDITURE BY PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES 77
3.1.4 INCREASE IN THE NUMBER OF ADVERSE DRUG REACTIONS (ADRS) 79
3.2 RESTRAINT 81
3.2.1 HIGH COST OF DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE 81
3.3 OPPORTUNITIES 83
3.3.1 AUTOMATION IN DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE 83
3.3.2 RESEARCH COLLABORATIONS AND PARTNERSHIPS 84
3.3.3 STRATEGIC INITIATIVES BY MARKET PLAYERS 86
3.4 CHALLENGE 87
3.4.1 THE MISREPORTING AND MISCODING OF ADVERSE EVENTS 87
4 EXECUTIVE SUMMARY 88
5 GLOBAL DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET, BY TYPE 93
5.1 OVERVIEW 94
5.2 SOFTWARE 96
5.2.1 ADVERSE EVENT REPORTING SOFTWARE 97
5.2.1.1 ON-PREMISE 97
5.2.1.2 CLOUD BASED 97
5.2.2 DRUG SAFETY AUDITS SOFTWARE 98
5.2.2.1 ON-PREMISE 98
5.2.2.2 CLOUD BASED 98
5.2.3 DATA MANAGEMENT SOFTWARE 99
5.2.3.1 ON-PREMISE 99
5.2.3.2 CLOUD BASED 99
5.2.4 FULLY INTEGRATED SOFTWARE 100
5.2.4.1 ON-PREMISE 100
5.2.4.2 CLOUD BASED 100
5.2.5 ISSUE TRACKING SOFTWARE 101
5.2.5.1 ON-PREMISE 101
5.2.5.2 CLOUD BASED 101
5.2.6 CLINICAL TRIAL MANAGEMENT SOLUTION 102
5.2.6.1 ON-PREMISE 102
5.2.6.2 CLOUD BASED 102
5.2.7 REGULATORY CONTENT AND INFORMATION MANAGEMENT SOFTWARE 103
5.2.7.1 ON-PREMISE 103
5.2.7.2 CLOUD BASED 103
5.2.8 MEDICAL AFFAIRS SOFTWARE 104
5.2.8.1 ON-PREMISE 104
5.2.8.2 CLOUD BASED 104
5.2.9 OTHERS 105
5.2.9.1 ON-PREMISE 105
5.2.9.2 CLOUD BASED 105
5.3 SERVICES 106
5.3.1 CLINICAL DATA MANAGEMENT 107
5.3.1.1 DATA ENTRY AND CASE PROCESSING 107
5.3.1.2 CLINICAL TRIAL MONITORING 107
5.3.1.3 CLINICAL TRIAL SAFETY SUBMISSIONS 107
5.3.1.4 CASE PROCESSING (SAES) 107
5.3.1.5 OTHERS 107
5.3.2 DRUG SAFETY SOLUTIONS 108
5.3.2.1 QUALITY AND MEDICAL REVIEW 108
5.3.2.2 LITERATURE AND SOCIAL MEDIA MONITORING 108
5.3.2.3 SAFETY DATABASE 108
5.3.2.4 INDIVIDUAL CASE STUDY REPORT 108
5.3.2.5 PERIODIC REPORTS 108
5.3.2.6 MEDICAL LITERATURE SEARCH 109
5.3.2.7 SIGNAL DETECTION 109
5.3.2.8 EXPEDITED REPORTS 109
5.3.2.9 OTHERS 109
5.3.3 AGGREGATE SAFETY REPORTING 109
5.3.4 REGULATORY SERVICES 109
5.3.4.1 SAFETY REGULATORY SUBMISSIONS 109
5.3.4.2 POST-MARKETING SURVEILLANCE 110
5.3.4.3 MEDICAL DEVICE VIGILANCE 110
5.3.4.4 REGULATORY CONSULTING 110
5.3.4.5 OTHERS 110
5.3.5 RISK MANAGEMENT SERVICES 110
5.3.6 MEDICAL INFORMATION CALL CENTER SERVICES 110
5.3.7 AUDIT SERVICES 110
5.3.8 TRAINING SUPPORT SERVICES 110
5.3.9 OTHERS 110
6 GLOBAL DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET,
BY END USERS 111
6.1 OVERVIEW 112
6.2 PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRIES 114
6.3 CONTRACT RESEARCH ORGANIZATIONS (CROS) 115
6.4 HOSPITALS 115
6.5 KPOS/BPOS 116
6.6 HEALTHCARE PROVIDERS 116
6.7 OTHERS 117
7 GLOBAL DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET,
BY DISTRIBUTION CHANNEL 118
7.1 OVERVIEW 119
7.2 DIRECT SALES 121
7.3 RETAIL SALES 121
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8 DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET, BY GEOGRAPHY 122
9 GLOBAL DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET,
BY GEOGRAPHY 123
9.1 OVERVIEW 123
9.2 NORTH AMERICA 128
9.2.1 U.S. 137
9.2.2 CANADA 143
9.2.3 MEXICO 149
9.3 EUROPE 155
9.3.1 GERMANY 165
9.3.2 UNITED KINGDOM 171
9.3.3 ITALY 177
9.3.4 FRANCE 183
9.3.5 SPAIN 189
9.3.6 RUSSIA 195
9.3.7 NETHERLANDS 201
9.3.8 SWITZERLAND 207
9.3.9 BELGIUM 213
9.3.10 TURKEY 219
9.3.11 AUSTRIA 225
9.3.12 IRELAND 231
9.3.13 NORWAY 237
9.3.14 HUNGARY 243
9.3.15 POLAND 249
9.3.16 LITHUANIA 255
9.3.17 REST OF EUROPE 261
9.4 ASIA-PACIFIC 262
9.4.1 CHINA 271
9.4.2 JAPAN 277
9.4.3 SOUTH KOREA 283
9.4.4 INDIA 289
9.4.5 AUSTRALIA 295
9.4.6 SINGAPORE 301
9.4.7 THAILAND 307
9.4.8 MALAYSIA 313
9.4.9 INDONESIA 319
9.4.10 PHILIPPINES 325
9.4.11 VIETNAM 331
9.4.12 REST OF ASIA-PACIFIC 337
9.5 SOUTH AMERICA 338
9.5.1 BRAZIL 347
9.5.2 ARGENTINA 353
9.5.3 PERU 359
9.5.4 REST OF SOUTH AMERICA 365
9.6 MIDDLE EAST AND AFRICA 366
9.6.1 UAE 375
9.6.2 SAUDI ARABIA 381
9.6.3 KUWAIT 387
9.6.4 SOUTH AFRICA 393
9.6.5 REST OF MIDDLE EAST AND AFRICA 399
10 GLOBAL DRUG SAFETY SOLUTIONS & PHARMACOVIGILANCE MARKET, COMPANY LANDSCAPE 400
10.1 COMPANY SHARE ANALYSIS: GLOBAL 400
10.2 COMPANY SHARE ANALYSIS: NORTH AMERICA 401
10.3 COMPANY SHARE ANALYSIS: EUROPE 402
10.4 COMPANY SHARE ANALYSIS: ASIA-PACIFIC 403
11 COMPANY PROFILE 404
11.1 SYNEOS HEALTH 404
11.1.1 COMPANY SNAPSHOT 404
11.1.2 REVENUE ANALYSIS 404
11.1.3 COMPANY SHARE ANALYSIS 405
11.1.4 SOLUTION PORTFOLIO 405
11.1.5 RECENT DEVELOPMENT 406
11.2 COVANCE INC. (A SUBSIDIARY OF LABCORP) 407
11.2.1 COMPANY SNAPSHOT 407
11.2.2 REVENUE ANALYSIS 407
11.2.3 COMPANY SHARE ANALYSIS 408
11.2.4 SERVICE PORTFOLIO 408
11.2.5 RECENT DEVELOPMENTS 409
11.3 COGNIZANT 410
11.3.1 COMPANY SNAPSHOT 410
11.3.2 REVENUE ANALYSIS 410
11.3.3 COMPANY SHARE ANALYSIS 411
11.3.4 SOLUTION PORTFOLIO 411
11.3.5 RECENT DEVELOPMENT 412
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11.4 ACCENTURE 413
11.4.1 COMPANY SNAPSHOT 413
11.4.2 REVENUE ANALYSIS 413
11.4.3 COMPANY SHARE ANALYSIS 414
11.4.4 SERVICE PORTFOLIO 414
11.4.5 RECENT DEVELOPMENTS 415
11.5 PAREXEL INTERNATIONAL CORPORATION 416
11.5.1 COMPANY SNAPSHOT 416
11.5.2 PRODUCT PORTFOLIO 416
11.5.3 RECENT DEVELOPMENTS 418
11.6 ORACLE 419
11.6.1 COMPANY SNAPSHOT 419
11.6.2 REVENUE ANALYSIS 419
11.6.3 SOLUTION PORTFOLIO 420
11.6.4 RECENT DEVELOPMENT 420
11.7 AB CUBE 421
11.7.1 COMPANY SNAPSHOT 421
11.7.2 SOLUTION PORTFOLIO 421
11.7.3 RECENT DEVELOPMENT 421
11.8 ARISGLOBAL 422
11.8.1 COMPANY SNAPSHOT 422
11.8.2 PRODUCT PORTFOLIO 422
11.8.3 RECENT DEVELOPMENTS 423
11.9 BIOCLINICA 424
11.9.1 COMPANY SNAPSHOT 424
11.9.2 SERVICE PORTFOLIO 424
11.9.3 RECENT DEVELOPMENTS 425
11.10 C3I 426
11.10.1 COMPANY SNAPSHOT 426
11.10.2 REVENUE ANALYSIS 426
11.10.3 SERVICE PORTFOLIO 427
11.10.4 RECENT DEVELOPMENTS 427
11.11 DRUG SAFETY SOLUTIONS LIMITED 428
11.11.1 COMPANY SNAPSHOT 428
11.11.2 SERVICE PORTFOLIO 428
11.11.3 RECENT DEVELOPMENT 428
11.12 ENNOV 429
11.12.1 COMPANY SNAPSHOT 429
11.12.2 PRODUCT PORTFOLIO 429
11.12.3 RECENT DEVELOPMENTS 430
11.13 ERGOMED PLC 431
11.13.1 COMPANY SNAPSHOT 431
11.13.2 REVENUE ANALYSIS 431
11.13.3 SERVICE PORTFOLIO 432
11.13.4 RECENT DEVELOPMENTS 432
11.14 GENPACT 433
11.14.1 COMPANY SNAPSHOT 433
11.14.2 REVENUE ANALYSIS 433
11.14.3 PRODUCT PORTFOLIO 434
11.14.4 RECENT DEVELOPMENTS 434
11.15 ICON PLC 435
11.15.1 COMPANY SNAPSHOT 435
11.15.2 REVENUE ANALYSIS 435
11.15.3 SERVICE PORTFOLIO 436
11.15.4 RECENT DEVELOPMENTS 436
11.16 IQVIA 437
11.16.1 COMPANY SNAPSHOT 437
11.16.2 REVENUE ANALYSIS 437
11.16.3 SOLUTION PORTFOLIO 438
11.16.4 RECENT DEVELOPMENTS 438
11.17 PHARMACEUTICAL PRODUCT DEVELOPMENT, LLC. 439
11.17.1 COMPANY SNAPSHOT 439
11.17.2 SERVICE PORTFOLIO 439
11.17.3 RECENT DEVELOPMENTS 440
11.18 PHARMACEUTICAL RESEARCH ASSOCIATES INC. 441
11.18.1 COMPANY SNAPSHOT 441
11.18.2 REVENUE ANALYSIS 441
11.18.3 SOLUTION PORTFOLIO 442
11.18.4 RECENT DEVELOPMENTS 442
11.19 UNITED BIOSOURCE LLC 443
11.19.1 COMPANY SNAPSHOT 443
11.19.2 SERVICE PORTFOLIO 443
11.19.3 RECENT DEVELOPMENT 445
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11.20 WORLDWIDE CLINICAL TRIALS 446
11.20.1 COMPANY SNAPSHOT 446
11.20.2 SERVICE PORTFOLIO 446
11.20.3 RECENT DEVELOPMENTS 448
12 QUESTIONNAIRE 449
13 RELATED REPORTS 455