Research and Markets: Clinical Outsourcing Strategy:
Selecting Partners and Managing Relationships
Outsourcing can be a cost-efficient means to achieve clinical objectives and ensure a drug's successful path through development. A clinical research organization (CRO) can provide flexibility and expertise to trial sponsors, complementing companies' core competencies. But poor CRO management will drive up trial costs, delay a drug's time to market, or at worst, lead to trial cancellation and threaten a drug's future.
Problems such as low patient enrollment, missed deadlines, language barriers, and inadequate vendor oversight can spiral clinical trials out of control — but you can take steps to avoid this fate. Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships is the tool you need to break through this thicket of problems and reach success. Craft preventative strategies that will increase patient numbers and achieve superior communications. Consult our CRO criteria rankings to find the right vendor partner for your project. Uncover real-company strategies for mitigating conflicts and develop creative tactics for managing day-to-day problems.
With so much at stake, your company can't afford to leave things to chance. CEI's hard-hitting research combines detailed survey data with insights from top clinical executives. Use this report to make immediate improvements to your clinical outsourcing strategies!
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
and more!
Key Topics Covered:
EXECUTIVE SUMMARY
CLINICAL OUTSOURCING STRATEGY
CRO SELECTION AND CONTRACT NEGOTIATION
MANAGING CRO RELATIONSHIPS
CHARTS & GRAPHS
Companies Mentioned:
Abraxis
Allergan
ARIAD Pharmaceuticals
AstraZeneca
BAROnova
Ipsen
Johnson & Johnson
Matrix Clinical Research Management
Medarex
Needham & Company
Novartis Consumer Health
Novo Nordisk
Nycomed
Schering-Plough
Shire Pharmaceuticals
Stromedix
Wyeth
Several smaller drug companies, consultancies and CRO experts also contributed to this research.