Clinical Outsourcing

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Dive into the experiences of trial stakeholders — including sponsors, CROs and site teams — in trial planning and execution. Findings focus on two critical components of trial success, site selection and patient recruitment, while also examining critical metrics, including trial staffing, costs, timelines and challenges. Use this information to better plan for challenges, including issues around patient enrollment and key trial milestones. At the same time, strengthen the CRO-sponsor relationship to share risk and increase communication, improve coordination across multiple vendors and implement innovative strategies.

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Report Details

Publication Date: June 2015
Pages: 316
Number of Companies: 60+
Chapters: 5
Metric:s 500+
Charts/Graphics: 280+

Top Reasons to Buy This Clinical Outsourcing Report

When possible, establish strategic alliances to share risk, strengthen CRO-sponsor relationships and increase communication: For companies outsourcing any aspect of a clinical trial, selecting the right vendor and effectively communicating sponsor needs are pivotal to success. Strategic alliances work well for companies that constantly conduct clinical trials. However, they are not always feasible, especially for smaller companies with fewer resources. Examine the relationships between sponsors and CROs, including the types of vendors employed, selection criteria and best practices for maintaining successful relationships. This report examines the relative value of strategic alliances with both CROs and research sites. Alliances are not always possible, and some executives are skeptical of the practice. As CROs become more involved in clinical trial planning — a trend projected to occur over the next three to five years — this attitude will shift.

Prepare your trial for success with the right vendor relationships and proper patient recruitment strategies:Patient recruitment rates among top challenges for clinical trials, and vendor selection can have a huge impact. Companies that consider recruitment obstacles concurrently with protocol design, look outside of clinical practices to reach enrollment quotes, and involve vendors early better align their organizations for trial success. This report addresses the resources and best practices necessary to facilitate desirable recruitment outcomes. In addition,Clinical Outsourcing examines new patient recruitment strategies, including the use of EHRs and social media.

Carefully consider site selection when mapping out clinical trials: Site selection and site monitoring are key components of clinical trials. As such, companies should consider site background and operations prior to enrolling patients to ensure that a location will fit trial needs. In addition, retaining a small percent of clinical site monitoring staffing in-house will help build internal expertise, ensure site visit consistency, and ultimately make sure that trial progress stays on track. The report explores sponsor and CRO site selection criteria and site management challenges. Use the benchmarks and best practices to strengthen communication and cultivate consistency in monitoring efforts.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual clinical development research reports.

Excerpt from Clinical Outsourcing – Leverage Sponsor

Life science companies involve a number of in-house clinical groups to facilitate their ongoing medical trials. When in-house teams are not enough, companies may seek the added expertise of either general or specialized contract research organizations (CROs) to support their studies. Large pharmaceutical companies may work with large CROs as part of a strategic alliance. A recent CenterWatch study estimated that among the Top 10 CROs, 71% of revenue comes from a mixture of functional service — or clinical activities such as monitoring and data management that are performed
outside the scope of a long-term agreement — and integrated alliances.1
Smaller companies may prefer to leverage CRO expertise on a case-by-case or transactional basis. Likewise, mid-sized and niche CROs report that higher percentages of their earnings — 60% — result from transactional relationships with pharma and device companies.

CROs may assist sponsors with both trial design and execution components.
Increasingly, surveyed teams anticipate transitioning some of their trial planning responsibilities to experienced CROs. During the planning phase, CROs may leverage their experience with specific therapeutic areas or regions to help teams plan out a feasible trial methodology. Once trials are underway, they may assist companies with operational trial components, from patient recruitment to site monitoring.

Table of Contents

Executive Summary

15           Study Methodology

18           Clinical Outsourcing: Five Recommendations for Success

31           Understanding the General Metrics Behind Clinical Outsourcing Practices

72           Track Clinical Trial Spend Using a Mixture of Customized and Off-the-Shelf Solutions

80           Avoid Clinical Trial Challenges by Planning Ahead

117        SELECT VENDORS AND MAINTAIN CRO-SPONSOR RELATIONSHIPS WITH TRUST AND COMMUNICATION

119        Previous Relationships and Vendor Expertise Drive CRO Selection

137        Manage Sponsor-Vendor Relationships with Open Communication

155        Cultivate Site Selection and Monitoring Practices with an Eye Toward Informal, Strategic Relationships

162        Understanding the Key Components Behind Companies’ Site Selection Processes

184        Involve Third Parties to Facilitate Consistent Site Monitoring Activities

212        Mitigate Patient Recruitment Challenges through Early Planning and Strategic Third-Party Involvement

215        Patient Recruitment Strategy: Distributing Key Responsibilities, Building Recruitment-Friendly Protocols and Initializing Clinical Trial Sites

247        Streamlining Patient Recruitment: Leveraging Multiple Channels to Attract Qualified Trial Candidates

268        Factor Projected Patient Recruitment Costs into the Clinical Trial Planning Process

276        Mitigating Patient Recruitment Challenges to Uphold Clinical Timelines

282        Clinical Trial Profiles

CHARTS AND GRAPHICS

13           Executive Summary

18           Clinical Outsourcing: Five Recommendations for Success

19           Figure E.1: Percentage of Life Science Teams Outsourcing Specific Clinical Activities

19           Figure E.2: Percentage of Teams Outsourcing Selected Activities, by Company Type

20           Figure E.3: Life Science Teams’ Average Percentage of Clinical Responsibility Outsourced, by Role

21           Figure E.4: Average Percentage of Clinical Responsibility Outsourced, by Company Type

22           Figure E.5: Process of Selecting Vendors for a Clinical Trial, by Company Size

24           Figure E.6: Comparing Primary Challenges Behind Sponsor-CRO Relationships

26           Figure E.7: Current Distribution of Sponsor and Vendor Responsibilities: All Pharmaceutical and Device Teams

27           Figure E.8: Projected Distribution of Sponsor and Vendor Responsibilities in 2020: All Pharmaceutical and Device Teams

29           Figure E.9: Average Ratings of Patient Recruitment Challenges: Pharmaceutical and Device Teams

31           Understanding the General Metrics Behind Clinical Outsourcing Practices

33           Figure 1.1: Percentage of Research Organizations Containing These Dedicated Teams: Pharmaceutical and Device Companies

34           Figure 1.2: Percentage of Research Organizations Containing These Dedicated Teams: Top 10 and Top 50 Companies

35           Figure 1.3: Percentage of Research Organizations Containing These Dedicated Teams: Pharma Affiliates

36           Figure 1.4: Percentage of Research Organizations Containing These Dedicated Teams: Small and Biotech Companies

37           Figure 1.5: Percentage of Research Organizations Containing These Dedicated Teams: Device Companies

38           Figure 1.6: Percentage of Research Organizations Containing These Dedicated Teams: CROs

39           Figure 1.7: Percentage of Research Organizations Containing These Dedicated Teams: Pharmaceutical and Device Companies (US and Canada)

40           Figure 1.8: Percentage of Research Organizations Containing These Dedicated Teams: Pharmaceutical and Device Companies (EU)

41           Figure 1.9: Percentage of Research Organizations Containing These Dedicated Teams: CROs (US)

41           Figure 1.10: Percentage of Research Organizations Containing These Dedicated Teams: CROs (EU)

45           Figure 1.11: Number of In-House and Outsourced FTEs for an Early-Stage Clinical Trial

45           Figure 1.12: Number of In-House and Outsourced FTEs for a Late-Stage Clinical Trial

46           Figure 1.13: Number of Senior-Level Staff Providing Oversight for a Clinical Trial, by Team

47           Figure 1.14: Number of VPs and Therapeutic Supervisors for a Clinical Trial, by Team

48           Figure 1.15: Number of CRAs for a Clinical Trial, by Team

48           Figure 1.16: Number of Data Managers for a Clinical Trial, by Team

49           Figure 1.17: Number of Biostatisticians for a Clinical Trial, by Team

50           Figure 1.18: Number of Project Managers for a Clinical Trial, by Team

50           Figure 1.19: Number of Medical Writers for a Clinical Trial, by Team

51           Figure 1.20: Number of Patient Recruiters for a Clinical Trial, by Team

52           Figure 1.21: Number of Regulatory Personnel for a Clinical Trial, by Team

52           Figure 1.22: Number of Clinical Trial Supplies Personnel for a Clinical Trial, by Team

53           Figure 1.23: Number of Drug Safety Personnel for a Clinical Trial, by Team

54           Figure 1.24: Percentage of Pharmaceutical and Device Teams Outsourcing Some Portion of Specific Clinical Activities

55           Figure 1.25: Average Percentage of Workload Outsourced for Specific Clinical Activities: Pharmaceutical and Device Teams

56           Figure 1.26: Average Percentage of Workload Outsourced for Specific Clinical Activities: Top 10 and Top 50 Teams

57           Figure 1.27: Average Percentage of Workload Outsourced for Specific Clinical Activities: Pharma Affiliate Teams

58           Figure 1.28: Average Percentage of Workload Outsourced for Specific Clinical Activities: Small Pharma and Biotech Teams

59           Figure 1.29: Average Percentage of Workload Outsourced for Specific Clinical Activities: Device Teams

60           Figure 1.30: Average Percentage of Workload Outsourced for Specific Clinical Activities: Pharmaceutical and Device Teams (US)

61           Figure 1.31: Average Percentage of Workload Outsourced for Specific Clinical Activities: Pharmaceutical and Device Teams (EU)

62           Figure 1.32: Current Distribution of Sponsor and Vendor Responsibilities: All Pharmaceutical and Device Teams

64           Figure 1.33: Current Distribution of Sponsor and Vendor Responsibilities, by Team Type

65           Figure 1.34: Current Distribution of Sponsor and Vendor Responsibilities, by Region

66           Figure 1.35: Projected Distribution of Sponsor and Vendor Responsibilities in 2020: All Pharmaceutical and Device Teams

67           Figure 1.36: Projected Distribution of Sponsor and Vendor Responsibilities in 2020, by Team Type

68           Figure 1.37: Projected Distribution of Sponsor and Vendor Responsibilities in 2020, by Region

69           Figure 1.38: Projected Clinical Strategy Changes by 2020: Sponsors and Vendors Share Trial Design and Execution Duties

70           Figure 1.39: Projected Clinical Strategy Changes by 2020: Sponsors and Vendors Share Trial Design Only

70           Figure 1.40: Projected Clinical Strategy Changes by 2020: Sponsors and Vendors Share Trial Execution Only

71           Figure 1.41: Projected Clinical Strategy Changes by 2020: Sponsors Design Trial and Vendors Execute Trial

72           Track Clinical Trial Spend Using a Mixture of Customized and Off-the-Shelf Solutions

73           Figure 1.42: Percentage of Teams Using Specific Platforms to Track Clinical Trial Spend: Pharmaceutical and Device Companies

75           Figure 1.43: Percentage of Teams Using Specific Platforms to Track Clinical Trial Spend: CROs

76           Figure 1.44: Percentage of Teams Using Specific Platforms to Track Clinical Trial Spend: Sites

77           Figure 1.45: Percentage of Teams Using Specific Platforms to Track Clinical Trial Spend: Pharmaceutical and Device Teams (US)

78           Figure 1.46: Percentage of Teams Using Specific Platforms to Track Clinical Trial Spend: Pharmaceutical and Device Teams (EU)

79           Figure 1.47: Teams Using Specific Platforms to Track Clinical Trial Spend, by Region: CROs

80           Avoid Clinical Trial Challenges by Planning Ahead

82           Figure 1.48: Average Ratings of Clinical Challenges: Pharmaceutical and Device Teams

83           Figure 1.49: Average Ratings of Clinical Challenges: Top 10 and Top 50 Teams

84           Figure 1.50: Average Ratings of Clinical Challenges: Pharma Affiliate Teams

86           Figure 1.51: Average Ratings of Clinical Challenges: Small Pharma and Biotech Teams

87           Figure 1.52: Average Ratings of Clinical Challenges: Device Teams

88           Figure 1.53: Average Ratings of Clinical Challenges: CROs

89           Figure 1.54: Average Ratings of Clinical Challenges: Sites

90           Figure 1.55: Average Ratings of Clinical Challenges: Pharmaceutical and Device Teams (US)

91           Figure 1.56: Average Ratings of Clinical Challenges: Pharmaceutical and Device Teams (EU)

92           Figure 1.57: Average Ratings of Clinical Challenges: CROs (US)

92           Figure 1.58: Average Ratings of Clinical Challenges: CROs (EU)

99           Figure 1.59: Average Number of Change Orders per Clinical Trial: Top 10 and Top 50 Teams with Global Responsibility

100         Figure 1.60: Average Number of Change Orders per Clinical Trial: Top 10 and Top 50 Affiliate Teams with Country-Level Responsibility

100        Figure 1.61: Average Number of Change Orders per Clinical Trial: Small Pharma and Biotech Teams

101        Figure 1.62: Average Number of Change Orders per Clinical Trial: Device Teams

102        Figure 1.63: Average Number of Change Orders per Clinical Trial: CROs

102        Figure 1.64: Average Number of Change Orders per Clinical Trial: Sites

103        Figure 1.65: Average Percentage of Change Orders, by Amendment Type: Pharmaceutical and Device Teams

104        Figure 1.66: Average Percentage of Change Orders, by Amendment Type: CROs

105        Figure 1.67: Average Percentage of Change Orders, by Amendment Type: Top 10 and Top 50 Teams with Global Responsibility

106        Figure 1.68: Average Percentage of Change Orders, by Amendment Type: Top 10 and Top 50 Affiliate Teams with Country-Level Responsibility

107        Figure 1.69: Average Percentage of Change Orders, by Amendment Type: Small Pharma and Biotech Teams

108        Figure 1.70: Average Percentage of Change Orders, by Amendment Type: Device Teams

109        Figure 1.71: Average Percentage of Change Orders, by Amendment Type: CROs

110        Figure 1.72: Average Percentage of Change Orders, by Amendment Type: Sites

112        Figure 1.73: Expected Cost of Trial Amendments: Trial Methodology

112        Figure 1.74: Expected Cost of Trial Amendments: Clinical Trial Duration (Pharmaceutical and Device Teams)

113        Figure 1.75: Expected Cost of Trial Amendments: Clinical Trial Duration (CROs and Sites)

113        Figure 1.76: Expected Cost of Trial Amendments: Patient Population

114        Figure 1.77: Expected Cost of Trial Amendments: Number or Type of Clinical Trial Sites (Pharmaceutical and Device Teams)

114        Figure 1.78: Expected Cost of Trial Amendments: Number or Type of Clinical Trial Sites (CROs)

115        Figure 1.79: Expected Cost of Trial Amendments: Site Visit Frequency

115        Figure 1.80: Expected Cost of Trial Amendments: Other

116        (Endnotes)

117        Select Vendors and Maintain CRO-Sponsor Relationships with Trust and Communication

119        Previous Relationships and Vendor Expertise Drive CRO Selection

121        Figure 2.1: Clinical Vendor Type(s) Used: Pharmaceutical and Device Teams

123        Figure 2.2: Clinical Vendor Type(s) Used: Top 10 and Top 50 Teams

124         Figure 2.3: Clinical Vendor Type(s) Used: Pharma Affiliate Teams

126        Figure 2.4: Clinical Vendor Type(s) Used: Pharmaceutical and Device Teams (US)

126        Figure 2.5: Clinical Vendor Type(s) Used: Pharmaceutical and Device Teams (EU)

132         Figure 2.6: Perceived Importance of Specific CRO Selection Criteria: Pharmaceutical and Device Teams

135         Figure 2.7: Perceived Importance of Specific CRO Selection Criterion: Pharmaceutical and Device Teams (US)

136         Figure 2.8: Perceived Importance of Specific CRO Selection Criterion: Pharmaceutical and Device Teams (EU)

137        Manage Sponsor-Vendor Relationships with Open Communication

140        Figure 2.9: Preferred CRO Relationship: All Pharmaceutical and Device Teams

140        Figure 2.10: Preferred CRO Relationship, by Team

141        Figure 2.11: Preferred CRO Relationship, by Region

143        Figure 2.12: Average Number of CROs per Clinical Trial: Top 10 and Top 50 Teams with Global Responsibility

144         Figure 2.13: Average Number of CROs per Clinical Trial: Top 10 and Top 50 Affiliate Teams with Country-Level Responsibility

145        Figure 2.14: Average Number of CROs per Clinical Trial: Small Pharma and Biotech Teams

145        Figure 2.15: Average Number of CROs per Clinical Trial: Device Teams

151        Figure 2.16: Primary Challenges Behind Sponsor–CRO Relationships: Pharmaceutical and Device Teams

151        Figure 2.17: Primary Challenges Behind Sponsor-CRO Relationships: Pharmaceutical and Device Teams, by Region

154        Figure 2.18: Primary Challenge in Sponsor–CRO Relationships from the CRO Perspective

155        Cultivate Site Selection and Monitoring Practices with an Eye Toward Informal, Strategic Relationships

157        Figure 3.1: Pharmaceutical and Device Teams’ Preferred Working Relationship with Sites

158        Figure 3.2: Pharmaceutical and Device Teams’ Preferred Working Relationship with Sites, by Team Type

159        Figure 3.3: Pharmaceutical and Device Teams’ Preferred Working Relationship with Sites, by Region

160        Figure 3.4: CROs’ Preferred Working Relationship with Sites

161        Figure 3.5: CROs’ Preferred Working Relationship with Sites, by Region

161        Figure 3.6: Sites’ Preferred Working Relationship with Pharmaceutical, Device and CRO Teams

162        Understanding the Key Components Behind Companies’ Site Selection Processes

163         Figure 3.7: Level of Importance Pharmaceutical and Device Teams Assign to Specific Site Selection Criteria

166         Figure 3.8: Level of Importance CROs Assign to Specific Site Selection Criteria

168         Figure 3.9: Level of Importance Sites Assign to Specific Site Selection Criteria

170         Figure 3.10: Level of Importance Pharmaceutical and Device Teams Assign to Specific Site Selection Criteria (US)

171         Figure 3.11: Level of Importance Pharmaceutical and Device Teams Assign to Specific Site Selection Criteria (EU)

172         Figure 3.12: Level of Importance CROs Assign to Specific Site Selection Criteria (US)

173         Figure 3.13: Level of Importance CROs Assign to Specific Site Selection Criteria (EU)

174         Figure 3.14: Level of Importance CROs Assign to Specific Site Selection Criteria (Emerging Markets)

176         Figure 3.15: Site Staffing: Number of FTEs per Clinical Trial, by Role

180        Figure 3.16: Average Number of Clinical Trial Sites per Trial: Top 10 and Top 50 Teams with Global Responsibility

180         Figure 3.17: Average Number of Clinical Trial Sites per Trial: Top 10 and Top 50 Affiliate Teams with Country-Level Responsibility

181        Figure 3.18: Average Number of Clinical Trial Sites per Trial: Small Pharma and Biotech Teams

182        Figure 3.19: Average Number of Clinical Trial Sites per Trial: Device Teams

183        Figure 3.20: Average Number of Clinical Trial Sites per Trial: CROs

184        Involve Third Parties to Facilitate Consistent Site Monitoring Activities

185        Figure 3.21: Current Distribution of Site Monitoring Responsibilities: Top 10 and Top 50 Teams with Global Responsibility

186         Figure 3.22: Current Distribution of Site Monitoring Responsibilities: Top 10 and Top 50 Affiliate Teams with Country-Level Responsibility

187        Figure 3.23: Current Distribution of Site Monitoring Responsibilities: Small Pharma and Biotech Teams

188        Figure 3.24: Current Distribution of Site Monitoring Responsibilities: Device Teams

190        Figure 3.25: Projected Distribution of Site Monitoring Responsibilities in 2020: Top 10 and Top 50 Teams with Global Responsibility

191        Figure 3.26: Projected Distribution of Site Monitoring Responsibilities in 2020: Top 10 and Top 50 Affiliate Teams with Country-Level Responsibility

192        Figure 3.27: Projected Distribution of Site Monitoring Responsibilities in 2020: Small Pharma and Biotech Teams

194        Figure 3.28: Projected Distribution of Site Monitoring Responsibilities in 2020: Device Teams

198        Figure 3.29: Average Ratings of Site Monitoring Challenges: Pharmaceutical and Device Teams

199        Figure 3.30: Average Ratings of Site Monitoring Challenges: Top 10 and Top 50 Teams

199         Figure 3.31: Average Ratings of Site Monitoring Challenges: Pharma Affiliate Teams

201        Figure 3.32: Average Ratings of Site Monitoring Challenges: Small Pharma and Biotech Teams

202        Figure 3.33: Average Ratings of Site Monitoring Challenges: Device Teams

203        Figure 3.34: Average Ratings of Site Monitoring Challenges: CROs

204        Figure 3.35: Average Ratings of Site Monitoring Challenges from the Clinical Site Perspective

206        Figure 3.36: Average Ratings of Site Monitoring Challenges: Pharmaceutical and Device Teams (US)

206        Figure 3.37: Average Ratings of Site Monitoring Challenges: Pharmaceutical and Device Teams (EU)

207        Figure 3.38: Average Ratings of Site Monitoring Challenges: CROs (US)

208         Figure 3.39: Average Ratings of Site Monitoring Challenges: CROs (EU)

210        Figure 3.40: Use of RBM, by Team Type

212        Mitigate Patient Recruitment Challenges through Early Planning and Strategic Third-Party Involvement

215        Patient Recruitment Strategy: Distributing Key Responsibilities, Building Recruitment-Friendly Protocols and Initializing Clinical Trial Sites

217        Figure 4.1: Distribution of Patient Recruitment Responsibilities: Pharmaceutical and Device Teams

219        Figure 4.2: Distribution of Patient Recruitment Responsibilities: CROs

221        Figure 4.3: Distribution of Patient Recruitment Responsibilities: Sites

223        Figure 4.4: Distribution of Patient Recruitment Responsibilities: Pharmaceutical and Device Teams (US)

224        Figure 4.5: Distribution of Patient Recruitment Responsibilities: Pharmaceutical and Device Teams (EU)

225        Figure 4.6: Distribution of Patient Recruitment Responsibilities: CROs (US)

226        Figure 4.7: Distribution of Patient Recruitment Responsibilities: CROs (EU)

227        Figure 4.8: Distribution of Patient Recruitment Responsibilities: CROs (Emerging Markets)

230        Figure 4.9: Distribution of Patient Demographic Research Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

230        Figure 4.10: Distribution of Patient Demographic Research Responsibilities: Small Pharma, Biotech and Device Teams

231        Figure 4.11: Distribution of Patient Demographic Research Responsibilities: CROs

233         Figure 4.12: Distribution of Advocacy Group Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

234        Figure 4.13: Distribution of Advocacy Group Responsibilities: Small Pharma, Biotech and Device Teams

234        Figure 4.14: Distribution of Advocacy Group Responsibilities: CROs

237         Figure 4.15: Distribution of Site Evaluation Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

238        Figure 4.16: Distribution of Site Evaluation Responsibilities: Small Pharma, Biotech and Device Teams

238        Figure 4.17: Distribution of Site Evaluation Responsibilities: CROs

239         Figure 4.18: Distribution of Site Training Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

240        Figure 4.19: Distribution of Site Training Responsibilities: Small Pharma, Biotech and Device Teams

240        Figure 4.20: Distribution of Site Training Responsibilities: CROs

241        Figure 4.21: Distribution of Informed Consent Management Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

242        Figure 4.22: Distribution of Informed Consent Management Responsibilities: Small Pharma, Biotech and Device Teams

243        Figure 4.23: Distribution of Informed Consent Management Responsibilities: CROs

245        Figure 4.24: Distribution of Database Maintenance Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

245        Figure 4.25: Distribution of Database Maintenance Responsibilities: Small Pharma, Biotech and Device Teams

246        Figure 4.26: Distribution of Database Maintenance Responsibilities: CROs

247         Streamlining Patient Recruitment: Leveraging Multiple Channels to Attract Qualified Trial Candidates

248         Figure 4.27: Distribution of Patient Referral Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

248        Figure 4.28: Distribution of Patient Referral Responsibilities: Small Pharma, Biotech and Device Teams

249        Figure 4.29: Distribution of Patient Referral Responsibilities: CROs

250        Figure 4.30: Distribution of Point-of-Care Patient Recruitment Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

250        Figure 4.31: Distribution of Point-of-Care Patient Recruitment Responsibilities: Small Pharma, Biotech and Device Teams

251        Figure 4.32: Distribution of Point-of-Care Patient Recruitment Responsibilities: CROs

252        Figure 4.33: Distribution of Patient Recruitment Kit Development Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

252        Figure 4.34: Distribution of Patient Recruitment Kit Development Responsibilities: Small Pharma, Biotech and Device Teams

253        Figure 4.35: Distribution of Patient Recruitment Kit Development Responsibilities: CROs

255        Figure 4.36: Distribution of Traditional Patient Recruitment Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

255        Figure 4.37: Distribution of Traditional Patient Recruitment Responsibilities: Small Pharma, Biotech and Device Teams

256        Figure 4.38: Distribution of Traditional Patient Recruitment Responsibilities: CROs

259        Figure 4.39: Percentage of Teams Using Social Media to Recruit Patients, by Company Type

260        Figure 4.40: Percentage of Teams Using Social Media to Recruit Patients, by Platform: Pharmaceutical and Device Teams

260        Figure 4.41: Percentage of Teams Using Social Media to Recruit Patients, by Platform: CROs

261        Figure 4.42: Percentage of Teams Using Social Media to Recruit Patients, by Platform: Sites

262        Figure 4.43: Distribution of Web-Based Patient Recruitment Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

263        Figure 4.44: Distribution of Web-Based Patient Recruitment Responsibilities: Small Pharma, Biotech and Device Teams

263        Figure 4.45: Distribution of Web-Based Patient Recruitment Responsibilities: CROs

264        Figure 4.46: Distribution of EMR Management Responsibilities: Top 10, Top 50 Teams and Their Affiliates, by Team Responsibility Level

265        Figure 4.47: Distribution of EMR Management Responsibilities: Small Pharma, Biotech and Device Teams

265        Figure 4.48: Distribution of EMR Management Responsibilities: CROs

268        Factor Projected Patient Recruitment Costs into the Clinical Trial Planning Process

269         Figure 4.49: Average Flat Rate of Specific Patient Recruitment Tasks: Life Science Companies and CROs

270         Figure 4.50: Average Cost per Hour of Specific Patient Recruitment Tasks: Life Science Companies and CROs

271        Figure 4.51: Flat Rate of Patient Recruitment Responsibilities: by Team

272        Figure 4.52: Cost per Hour of Patient Recruitment Responsibilities, by Team

276        Figure 4.53: Average Ratings of Patient Recruitment Challenges: Pharmaceutical and Device Teams

276        Mitigating Patient Recruitment Challenges to Uphold Clinical Timelines

277        Figure 4.54: Average Ratings of Patient Recruitment Challenges: CROs

277        Figure 4.55: Average Ratings of Patient Recruitment Challenges: Sites

278        Figure 4.56: Average Ratings of Patient Recruitment Challenges: Pharmaceutical and Device Teams (US)

279        Figure 4.57: Average Ratings of Patient Recruitment Challenges: Pharmaceutical and Device Teams (EU)

282        Clinical Trial Profiles

284        Figure 5.1: Top 10 Company 1, US Team (Global Responsibility): General Trial Information

285         Figure 5.2: Top 10 Company 3, US Affiliate Team (Country-Level Responsibility): General Trial Information

286         Figure 5.3: Top 10 Company 3, US Affiliate Team (Country-Level Responsibility): Trial Staffing Data

287        Figure 5.4: Top 50 Company 5, US Team (Global Responsibility): General Trial Information

288         Figure 5.5: Top 50 Company 5, US Team (Global Responsibility): Trial Staffing Data

289        Figure 5.6: Top 50 Company 5, US Team (Global Responsibility): Selected Trial Costs

290        Figure 5.7: Top 50 Company 6, EU Team (Global Responsibility): General Trial Information

291         Figure 5.8: Top 50 Company 6, EU Team (Global Responsibility): Trial Staffing Data

292        Figure 5.9: Top 50 Company 6, EU Team (Global Responsibility): Selected Trial Costs

293        Figure 5.10: Small Company 9, EU Team (Global Responsibility): General Trial Information

294        Figure 5.11: Biotech Company 12, US Team (Global Responsibility): General Trial Information

295         Figure 5.12: Biotech Company 12, US Team (Global Responsibility): Trial Staffing Data

296        Figure 5.13: Biotech Company 13, US Team (Global Responsibility): General Information

297         Figure 5.14: Biotech Company 13, US Team (Global Responsibility): Trial Staffing Data

298        Figure 5.15: Device Company 15, US Team (Global Responsibility): General Trial Information

299         Figure 5.16: Device Company 15, US Team (Global Responsibility): Trial Staffing Data

300        Figure 5.17: Device Company 15, US Team (Global Responsibility): Selected Trial Costs

301        Figure 5.18: Device Company 17, US Team (Global Responsibility): General Trial Information

302         Figure 5.19: Device Company 17, US Team (Global Responsibility): Trial Staffing Data

303        Figure 5.20: Device Company 18, US Team (Global Responsibility): General Trial Information

304         Figure 5.21: Device Company 18, US Team (Global Responsibility): Trial Staffing Data

305        Figure 5.22: CRO Company 30, US Team (Global Responsibility): General Trial Information

306        Figure 5.23: CRO Company 30, US Team (Global Responsibility): Selected Trial Costs

307        Figure 5.24: CRO Company 31, US Team (Global Responsibility): General Trial Information

308        Figure 5.25: CRO Company 56, US Team (Global Responsibility): General Trial Information

309         Figure 5.26: CRO Company 56, US Team (Global Responsibility): Trial Staffing Data

310        Figure 5.27: CRO Company 25, EU Team (Global Responsibility): General Trial Information

311        Figure 5.28: CRO Company 20, Emerging Markets Team (Global Responsibility): General Trial Information

312         Figure 5.29: CRO Company 20, Emerging Markets Team (Global Responsibility): Trial Staffing Data

313        Figure 5.30: CRO Company 28, Emerging Markets Team (Global Responsibility): General Trial Information

314        Figure 5.31: CRO Company 29, Emerging Markets Team (Global Responsibility): General Trial Information

315         Figure 5.32: CRO Company 29, Emerging Markets Team (Global Responsibility): Trial Staffing Data

316        Figure 5.33: CRO Company 29, Emerging Markets Team (Global Responsibility): Selected Trial Costs