Investigate into Patient and Investigator Recruitment and Retention - Two of the Most Costly & Time Consuming Aspects of Trial Operations.

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c49382) has announced the addition of Clinical Operations: Accelerating Trials, Allocating Resources & Measuring Performance to their offering.

Clinical Operations: Accelerating Trials, Allocating Resources & Measuring Performance is a comprehensive tool designed to help clinical trial operations departments, trial managers, and clinical development function heads benchmark performance and generally enhance clinical operations at their companies.

The report covers operational performance enhancement and clinical benchmarking from several angles, including:

Clinical Trial Resource Allocation Benchmarks - This section of the report analyzes clinical trial budgets and staffing levels by development phase (including Phase 1, Phase 2, Phase 3 and Phase 4 studies) and therapeutic area. Budgeting benchmarks are provided for several therapeutic areas, including analgesia and rheumatology, autoimmune diseases, cardio and thrombosis, CNS/psychology, gastroenterology, infectious diseases, musculoskeletal and oncology, among others.

Trial-specific staffing data from more than 70 clinical trials are included. Staffing data are segmented for all key clinical development roles and functions, including therapeutic area heads, clinical trial managers, CRAs, data management, medical writing, biostatistics/bioanalytics, regulatory, clinical quality assurance, clinical trial supplies, contracts management, CMC and drug safety.

Clinical Operations Performance Measurement - The report also analyzes key performance indicators used by clinical development organizations to drive continuous process improvement. Performance measures are divided into three main categories, including time-based milestones/cycle times, resources (budgets/costs and staffing), and efficiency and operational quality metrics. Surveyed companies provide actual and target performance benchmarks for a variety of metrics in these three categories.

Continuous Process Improvement - A dozen of the most consistently troublesome and time-consuming clinical development bottlenecks are analyzed in case study format. Executives consulted in the development of this report provide their innovative suggestions for removing these bottlenecks and accelerating overall clinical development. Also, the report dedicates a full chapter to two areas that are often cited as the most costly and time consuming aspects of trial operations: patient and investigator recruitment and retention.

Topics Covered

Executive Summary

Clinical Trials Resource Allocation

Per-Patient Costs and Outsourced Spending

Therapeutic Area Costs Per Patient

Clinical Operations Budgeting Process

Phase-by-Phase Clinical Staffing

Clinical Trial Performance Measurement

Clinical Trial Performance Metrics Tracked

Clinical Trial Performance Metrics: Actual vs. Target Performance

Continuous Process Improvement

Study Planning and Set Up

Study Conduct

Study Analysis and Close Out

Recruiting and Retaining Patients and Investigators

Patient Retention and Compliance

Investigator Recruitment and Incentives

Executive Summary

Clinical Trials Resource Allocation

Across Therapeutic Areas (by Phase, US)

Per-Patient Costs and Outsourced Spending

Therapeutic Area Costs Per Patient

Phase-by-Phase Clinical Staffing

Charts And Graphics

Clinical Operations?

Charts And Graphics

Time Milestones

Efficiency/Operational Performance

Efficiency/Operational Performance

Clinical Trial Performance Metrics: Actual vs. Target Performance

Continuous Process Improvement

Study Planning and Set Up

Contracting

Recruiting and Retaining Patients and Investigators

Patient Retention and Compliance

Investigator Recruitment and Incentives

Companies Mentioned

-Advanced Biologics - Allergan - Allon Therapeutics - Amgen - APEX -Beijing Bionovo Medical Technique Co. -Cadila Pharmaceuticals - Cell Therapeutics - Cephalon - ClinPro - CombinatoRx - Discovery Alliance - Dr. Reddy's Laboratories - Genzyme - Gilead Sciences - GlaxoSmithKline - Hill-Rom - Institute of Clinical Research - Isotechnika - KAIPharmaceuticals - Medtronic - Merck - Millennium Pharmaceuticals - Neurogen - Optimata - Ortho-McNeil Janssen - Premier Research Group- PSI Pharma Support - QLT - Research Corporation Technologies - Schering-Plough - SCIREX - Serono - Stryker Orthopedics - Terumo Medical Corporation - UCB Pharmaceuticals - ZLB Behring

For more information visit http://www.researchandmarkets.com/reports/c49382