Clinical Outsourcing Strategy

Summary

Perfect the CRO selection and management process - and guarantee trial success

Outsourcing is a powerful option for achieving clinical objectives, allowing pharma companies to expand their reach in a therapeutic area, leverage vendors' expertise, and usher a drug through development smoothly - all without overburdening resources.

With such benefits come giant obstacles, however. If managed poorly, clinical outsourcing can cause pharma companies to scramble around, regretting decisions and reacting constantly to problems such as trial under-enrollment, numerous change orders, and weak oversight. CRO management problems can also lead to trial overruns - resulting in hundreds of thousands of dollars wasted and an uncertain market future for a drug. Hitting some snags in the clinical process is unavoidable, but this scenario is the exact opposite of what clinical outsourcing is aimed to solve.

Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships will guide your company to adopt a proactive approach. It identifies key questions every trial sponsor should consider before engaging with a client, such as: How does patient recruitment fit into outsourcing strategy? Does this CRO have a reputation for meeting deadlines? Will this CRO's size allow it to meet my needs for a trial?

Use this report to navigate confidently through the CRO selection and management process:

• Determine which factors to weigh when developing outsourcing strategy
• Base vendor selection upon CRO criteria and rankings
• Understand the advantages and risks of outsourcing to international sites
• Accelerate and streamline the CRO selection timeline/process

200+ Metrics

34 Charts and Diagrams

Outsourcing Strategy and Vendor Selection

A major difficulty faced by most teams is disagreement over vendor selection. From a strategic perspective, a CRO's (or other vendor's) size and reach factor directly into project plans. Different stakeholders will advocate niche- or full-service options, and the potential use of different vendors will impact decisions around specific activities. On a broader level, vendor ability to deliver satisfactory results for any given task will impact project management and outsourcing strategy.

Multifunctional involvement in the setting of outsourcing strategy ultimately aids vendor selection. Involving key stakeholders at an early point helps to align expectations, objectives and processes. In other words, as one sourcing executive put it, working across functions "gets everyone on the same page." Different individuals and groups have the opportunity to share opinions on key tasks, in-house needs and vendor capabilities as the lead team determines what to outsource and to whom they should hand specific activities.

As the process continues, internal familiarity helps to defuse - or at least lessen - inevitable differences and keep outsourcing strategy focused. If stakeholders are used to working together, they are more likely to find common ground when called upon to make project decisions. To one degree or another, shared experience and strategic vision provide a working foundation for all stakeholders.

One strategic path that aids in this process, the use of preferred vendors, can deliver outstanding results - or leave clients with a project's worth of unfulfilled promises. The best ongoing relationships position vendors as external arms of the clinical development group. Over time, they build deep knowledge of client objectives, processes and concerns. That information, combined with strong working relationships forged by constant contact in project after project, positions the vendor to best meet sponsor needs.

When the system works, it eliminates the need for a lengthy vendor-selection process. Better yet, the client knows what to expect and does not have to spend time training the vendor in internal minutiae.

One surveyed company works with only two CROs, and it trusts them to deliver high-quality results on schedule. "All of the projects that we've done with them were on time," says one executive at the company. "They never overpromise, the quality is really good and they do more than most of the others in customer satisfaction."

The following excerpt is taken from Chapter 2, "CRO Selection and Contract Negotiation, "Cleaning Up the CRO Selection Process."

While a majority of respondents were happy with the amount of time this process took, Figure 2.22 [data charts appear in complete report] shows that one third felt that it took too long at their company. Many surveyed companies suggest improving the vendor selection process by way of more consistent and transparent costing across vendors. Because each vendor uses different units in calculating overall trial costs, comparing the quality of the quote was very difficult. This becomes especially complex, when companies are considering which changes will likely need to be made to a trial, as each vendor would assess different categories of charges as well as different rates.

Two executives independently suggested requiring CROs to fill out a template provided by the pharmaceutical company along with the CRO's proposal. While some CROs will refuse to provide a quote in any format other than their own proprietary one, smaller CROs may be willing to work with a pharmaceutical company's template. If multiple CROs fill out the same template, then costs can be fairly compared between the CROs' templates.

One criterion that did affect the total proposal process time was whether the CRO was a preferred vendor. Using a preferred vendor saves an average of one to 10 days depending on the phase, as seen in Figure 2.23. The smallest of missteps in the patient recruitment process can cost more time than preferred status saves, but at the same time, every extra day can help in the time-sensitive clinical trial process.

Contents

• Executive Summary
  • Profiled Companies
  • Methodology And Definitions
  • Clinical Trial Outsourcing: Five Principles For Success
• Clinical Outsourcing Strategy
  • Top Three Questions To Ask When Setting Outsourcing Strategy
  • Evaluation Of Core Clinical Development Capabilities
  • A Strategic Bottleneck: Outsourcing Patient Recruitment
• Cro Selection And Contract Negotiation
  • Top Three Questions To Ask A Cro Candidate
  • Importance Of Cro Criteria
  • Cro Ratings
  • Managing The Proposal Submission Process
• Managing Cro Relationships
  • Top Three Questions To Ask When Managing Cros
  • Cro Contract Negotiation
  • Finding Payment Structures That Work
• Executive Summary
• Clinical Outsourcing Strategy
  • Evaluation Of Core Clinical Development Capabilities
  • Figure 1.1: Executives Involved In Determining Which Activities Will Be Outsourced
  • Figure 1.2: Percentage Of Companies Outsourcing Activities In A Majority Of Trials
  • Figure 1.3: Percentage Of Companies Outsourcing Specific Activities In At Least One
  • Trial By Contract Type
• Cro Selection And Contract Negotiation
  • Figure 2.1: Importance Of Cro's Ability To Meet Deadlines, By Company
• Top Three Questions To Ask A Cro Candidate
  • Figure 2.2: Importance Of Company Size And Geographical Reach When Selecting Cros
  • Figure 2.3: Executives Involved In Selecting The Cros/Vendors
  • Figure 2.4: Importance Of Overall Cost And Preferred Status When Selecting Cros
• Importance Of Cro Criteria
  • Figure 2.5: Importance Of Company Size And Geographical Reach When Selecting Cros
  • Figure 2.6: Importance Of Work Quality When Selecting Cros
  • Figure 2.7: Importance Of Relationship Management When Selecting Cros
  • Figure 2.8: Importance Of Experience With Similar Products When Selecting Cros
  • Figure 2.9: Other Considerations When Selecting Cros
  • Figure 2.10: Performance Ratings For Quintiles
• Cro Ratings
  • Figure 2.11: Performance Ratings For Ppd
  • Figure 2.12: Performance Ratings For Covance
  • Figure 2.13: Performance Ratings For Parexel
  • Figure 2.14: Performance Ratings For Icon
  • Figure 2.15: Number Of Cros Receiving Rfps, By Phase
• Managing The Proposal Submission Process
  • Figure 2.16: Weeks Elapsed From Rfps Sent To Proposal Submission Deadline, By Phase
  • Figure 2.17: Number Of Cros Submitting Proposals, By Phase
  • Figure 2.18: Percentage Of Respondents Happy With Number Of Proposals Received
  • Figure 2.19: Weeks Elapsed From Proposal Submission Deadline To Final Cro/Vendor Selection, By Phase
  • Figure 2.20: Number Of Cros That Make The Final Cut, By Phase
  • Figure 2.21: Weeks Elapsed From Final Cro/Vendor Selection To Project Kick-Off, By Phase
  • Figure 2.22: Percentage Of Respondents Happy With Amount Of Time Proposal Process Takes
  • Figure 2.23: Time Spent Negotiating Contracts With Cros/Vendors, In Days
• Managing Cro Relationships
  • Top Three Questions To Ask When Managing Cros
  • Figure 3.1: Performance Tracking And Accountability (Company E)
  • Figure 3.2: Clinical Trial Management Issues (Company E)
  • Figure 3.3: Executives Involved In Negotiating Contracts With Cros/Vendors
• Cro Contract Negotiation
  • Figure 3.4: Number Of Days Spent Negotiating Agreements With Preferred Vendors, By Phase
  • Figure 3.5: Number Of Days Spent Negotiating Agreements With Non-Preferred Vendors, By Phase
  • Figure 3.6: Additional Time Spent Negotiating Contracts With Non-Preferred Vendors, By Phase
• Finding Payment Structures That Work
  • Figure 3.7: Executives Involved In Day-To-Day Oversight Of Cro/Vendor's Work
  • Figure 3.8: Management Of Future Contracts With A Problematic Vendor (Company E)