2014年4月28日星期一

Clinical Research Software

Clinical research software can provide a single, integrated data capture and study management platform for post-approval research and registries conducted by biopharmaceutical and medical device companies, Clinical Research Organizations (CROs) and Academic Medical Centers (AMCs). Clinical research software integrates the two core functional needs of any clinical study, Clinical Data Capture and Study Management, into a single platform. Many software companies on the Internet today are willing to deliver via a web-based, on-demand architecture that streamlines clinical studies by eliminating the integration headaches associated with multiple unrelated platforms, reducing project efforts and costs from startup to conclusion, and empowering project stakeholders to make informed real-time decisions regarding their research. The benefit of obtaining your clinical research software online is you can get your programs right away, and if you have any question, they are right there online line only a click away. The clinical research software you choose is designed to make the process of conducting clinical trials, more efficient, more organized, more accurate, and more profitable. It enables research administrators to closely manage study operations and financials, while making daily operations easier and less error-prone for coordinators, recruiters, physicians, and other staff.



Companies are under increasing pressure to replace revenue sources as blockbuster drugs come off patent. With new drug discoveries focusing on smaller, targeted populations, and market dynamics limiting the revenue potential of other drugs, life science companies are being forced to lower development costs and bring more drugs to market. This, in addition to recent drug safety concerns, substantial increases in data volume, and rising cost pressures, present these organizations with some very significant business challenges. According to a Tufts University study, it costs an average of $800 million to get a new drug to market. Clinical trials account for the bulk of this number. Fine-tuning existing, paper-based trial processes to lower costs has reached its limits. Changing to good clinical research software can help companies realize significant cost savings, as well as time, efficiency, and quality gains. The software creates a comprehensive data capture and management environment to conduct electronic, paper-based, and hybrid clinical trials as well as facilitates quicker, accurate and less resource-intensive data capture and validation through front-end EDC integration. By leveraging the clinical software site-based electronic data collection, the amount of time required for data entry is reduced, redundant workflow is eliminated, and data accuracy is improved. The automated point-of-entry cleaning capabilities help decrease query cut resolution cycle times, volume, and lower operational costs. You choose where to execute edit checks, selecting the system most suited for resolution. Automated query synchronization moves final resolved queries back to the system, complete with a single consolidated query audit trail history. Batch loading and batch validation, lab loading, lab normal-range checking and advanced coding features are all fully supported in the system.



Both systems work in an integrated manner to provide the most comprehensive dataset possible in the shortest amount of time. Faster data entry and faster data cleaning make clinical data available earlier for faster database lock.Links:
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