Clinical Outsourcing Strategy Selecting Partners and Managing Relationships

Clinical Outsourcing Strategy Selecting Partners and Managing Relationships

Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships (PH 125)

Overview

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

Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships will guide your company to adopt a proactive approach to avoiding common pitfalls in the clinical trial process. 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

...and more!

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

Companies Included in Report

Abraxis

Allergan

ARIAD Pharmaceuticals

AstraZeneca

BAROnova

Ipsen

Isis Pharmaceuticals

Johnson & Johnson

Matrix Clinical Research Management

Medarex

Needham & Company

Novartis Consumer Health

Novo Nordisk

Nycomed

Schering-Plough

Shire Pharmaceuticals

Stromedix

Wyeth

Sample Content from the Report

The following excerpt is taken from Chapter 1, "Clinical Outsourcing Strategy" section 1, "Evaluation of Core Clinical Development Capabilities."

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.

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