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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 segemented 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.

 

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