Research and Markets: Strategic Clinical Sourcing: Managing Costs and CROs

DUBLIN--(Business Wire)--
Research and Markets
(http://www.researchandmarkets.com/research/abcbdf/strategic_clinical) has
announced the addition of Cutting Edge Information's new report "Strategic
Clinical Sourcing: Managing Costs and CROs" to their offering.

Strategic Clinical Sourcing: Managing Costs and CROs is an in-depth look at the
entire clinical outsourcing process. Our study analyzes outsourcing strategies,
costs, and timelines of top pharmaceutical companies.

* Set a winning strategy: Learn how to optimize your available resources and
avoid problems in key aspects like patient recruitment.
* Control costs and limit waste: Consult real-world examples of trial costs at
all phases of development. Find per unit hour metrics for nine roles/positions
ensure that you are paying CROs at a reasonable rate.
* Select the right vendor and negotiate a deal: Examine rankings for 25 CRO
traits over six different categories.
* Manage the relationship successfully: Adapt real-company strategies to
resolving conflicts and ensuring acceptable compensation structures.

Key Metrics

Strategic Clinical Sourcing: Managing Costs and CROs four chapters contain trial
cost, staffing and timeline metrics. They include the following:

Chapter 1: Clinical Outsourcing Strategy

* Executives involved in determining which activities will be outsourced
* Percentage of companies outsourcing clinical trial activities
* Percentage of companies outsourcing clinical trial activities by type

Chapter 2: Outsourced Trial Cost Management

* Percentage of companies outsourcing position/roles, including trial managers,
CRAs and monitors, data management, patient recruiters, clinical trial supplies
and biostatistics
* Total trial costs by development phase II, III, and IV
* Staffing and cost per unit hour metrics are included for nine roles/
positions:
* CRA/monitoring
* Trial management
* Data management
* Biostatistics/bioanalytics
* Patient recruitment
* Clinical trial supplies
* Medical writing
* Regulatory
* Senior level oversight

Prevalence of trials taking place in major regions worldwide: Asia/Pacific,
Europe, Americas

Chapter 3: CRO Selection and Contract Negotiation:

CRO Criteria: Importance of:

* a CRO's ability to meet deadlines, by company
* company size and geographical reach when selecting CROs
* overall cost and preferred status when selecting CROs
* work quality when selecting CROs
* relationship management when selecting CROs
* experience with similar products when selecting CROs
* other considerations: turnover rate, knowledge of regulatory concerns and
intellectual property

CRO Performance Ratings On a scale of 1 to 5 - with 5 being best - study
participants rate actual CROs on:

* price
* reach
* work quality
* therapeutic area/drug experience
* relationship management

CRO Selection Process Timeline Metrics:

* Number of CROs receiving RFPs
* Weeks elapsed from RFPs sent to proposal submission deadline
* Number of CROs submitting proposals, by phase
* Weeks elapsed from proposal deadline to final CRO/vendor selection, by phase
* Number of CROs that make the final cut
* Percentage of respondents happy with amount of time proposal process takes
* Time spent negotiating contracts with CROs/vendors, in days

Chapter 4: Managing CROs and Monitoring Trial Metrics:-

Relationship Management:

* Performance tracking and accountability (reporting structure of a surveyed
company)
* Clinical trial management issues (surveyed company example)
* Executives involved in negotiating contracts with CROs/vendors
* Number of days spent negotiating agreements with preferred vendors versus
non-preferred vendors
* Executives involved in day-to-day oversight of CRO/vendor's work
* Management of future contracts with a problematic vendors

Timeline metrics

* Percentage of reported trials by phase:
* Trial disease state
* Length of time from protocol finalization to first patient's first visit (in
months)
* Length of time from first patient visit to last patient's last visit
* Length of time from last patient visit to clinical trial report
* Target patient enrollment
* Effect of target patient enrollment on months taken to collect data

For more information visit
http://www.researchandmarkets.com/research/abcbdf/strategic_clinical

Research and Markets
Laura Wood, Senior Manager,
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Copyright Business Wire 2009