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 resource allocation Managed care The constellation of activities and decisions which form the basis for prioritizing health care needs 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 analgesia /an·al·ge·sia/ (an?al-je´ze-ah) 1. absence of sensibility to pain. 2. the relief of pain without loss of consciousness. and rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. , autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , cardio and thrombosis, CNS/psychology, gastroenterology gastroenterology Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833. , infectious diseases, musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles. mus·cu·lo·skel·e·tal adj. Relating to or involving the muscles and the skeleton. 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 (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. and drug safety. Clinical Operations Performance Measurement - The report also analyzes key performance indicators Key Performance Indicators (KPI) are financial and non-financial metrics used to quantify objectives to reflect strategic performance of an organization. KPIs are used in Business Intelligence to assess the present state of the business and to prescribe a course of action. 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 Ceph´a`lon n. 1. (Zool.) The head. - ClinPro - CombinatoRx - Discovery Alliance - Dr. Reddy's Laboratories Dr. Reddy’s Laboratories Ltd. (Reddy's), founded in 1984 by Dr. K. Anji Reddy, has become India’s third biggest pharmaceutical company. Reddy had worked in the publicly-owned Indian Drugs and Pharmaceuticals Ltd. - 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 QLT Quadra Logic Technologies QLT Quick Link Text - Research Corporation Technologies - Schering-Plough - SCIREX - Serono - Stryker Orthopedics - Terumo Medical Corporation - UCB UCB - University of California at Berkeley Pharmaceuticals - ZLB ZLB Zero Length Body ZLB Zero Length Bit Behring For more information visit http://www.researchandmarkets.com/reports/c49382 |
|
Printer friendly
Cite/link
Email
Feedback
Reader Opinion