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1. 发明申请

WO2002044868A3 METHOD AND APPARATUS OF ASSURING INFORMED CONSENT WHILE CONDUCTING SECURE CLINICAL TRIALS 审中-公开
公开(公告)号：WO2002044868A3
公开(公告)日：2002-06-06
申请号：PCT/US2001/051091
申请日：2001-11-13
申请人： MEDIDATA SOLUTIONS, INC. , DE VRIES, Glen, M. , IKEGUCHI, Edward, F. , TE, Alexis, E.
发明人： DE VRIES, Glen, M. , IKEGUCHI, Edward, F. , TE, Alexis, E.
IPC分类号： G06F17/30
摘要： The present invention is a method for conducting clinical trials. The clinical trial consists of the inventive system (10); a computing device (12); application database (11a), the personnel database (11b), and the trial data database; computing devices (14a), (14b), and (14c) for use by trial participants and trial investigators; computing device (15); computer devices (16a), (16b), and (16c) for use by trial monitors; computing devices (18a), (18b), and (18c) for use by laboratories to connect via the network (20).

2. 发明申请

WO0244868A9 METHOD AND APPARATUS OF ASSURING INFORMED CONSENT WHILE CONDUCTING SECURE CLINICAL TRIALS 审中-公开
标题翻译：确保安全临床试验中通报的同意书的方法和装置
公开(公告)号：WO0244868A9
公开(公告)日：2003-03-27
申请号：PCT/US0151091
申请日：2001-11-13
申请人： MEDIDATA SOLUTIONS INC , DE VRIES GLEN M , IKEGUCHI EDWARD F , TE ALEXIS E
发明人： DE VRIES GLEN M , IKEGUCHI EDWARD F , TE ALEXIS E
IPC分类号： G06F7/00 , G06F19/00 , G06F17/30
CPC分类号： G16H80/00 , G06F19/321 , G06F19/325 , G06F19/3418 , G16H10/20 , Y10S707/99931
摘要： The present invention is a method for conducting clinical trials. The clinical trial consists of the inventive system (10); a computing device (12); application database (11a), the personnel database (11b), and the trial data database; computing devices (14a), (14b), and (14c) for use by trial participants and trial investigators; computing device (15); computer devices (16a), (16b), and (16c) for use by trial monitors; computing devices (18a), (18b), and (18c) for use by laboratories to connect via the network (20).
摘要翻译：本发明是进行临床试验的方法。临床试验包括本发明的系统（10）; 计算设备（12）; 应用数据库（11a），人事数据库（11b）和试用数据数据库; 计算设备（14a），（14b）和（14c）供试用参与者和试用调查员使用; 计算装置（15）; 计算机装置（16a），（16b）和（16c）供试验监视器使用; 计算设备（18a），（18b）和（18c），供实验室使用以经由网络（20）连接。

3. 发明申请

WO0244868A2 METHOD AND APPARATUS OF ASSURING INFORMED CONSENT WHILE CONDUCTING SECURE CLINICAL TRIALS 审中-公开
标题翻译：确保安全临床试验中通报的同意书的方法和装置
公开(公告)号：WO0244868A2
公开(公告)日：2002-06-06
申请号：PCT/US0151091
申请日：2001-11-13
申请人： MEDIDATA SOLUTIONS INC , VRIES GLEN M DE , IKEGUCHI EDWARD F , TE ALEXIS E
发明人： DE VRIES GLEN M , IKEGUCHI EDWARD F , TE ALEXIS E
IPC分类号： G06F7/00 , G06F19/00 , G06F
CPC分类号： G16H80/00 , G06F19/321 , G06F19/325 , G06F19/3418 , G16H10/20 , Y10S707/99931
摘要： The present invention is a method for conducting clinical trials. The clinical trial consists of the inventive system (10); a computing device (12); application database (11a), the personnel database (11b), and the trial data database; computing devices (14a), (14b), and (14c) for use by trial participants and trial investigators; computing device (15); computer devices (16a), (16b), and (16c) for use by trial monitors; computing devices (18a), (18b), and (18c) for use by laboratories to connect via the network (20).
摘要翻译：本发明是进行临床试验的方法。临床试验包括本发明的系统（10）; 计算设备（12）; 应用数据库（11a），人事数据库（11b）和试用数据数据库; 计算设备（14a），（14b）和（14c）供试用参与者和试用调查员使用; 计算装置（15）; 计算机装置（16a），（16b）和（16c）供试验监视器使用; 计算设备（18a），（18b）和（18c），供实验室使用以经由网络（20）连接。

4. 发明申请

WO2005031509A3 SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF AN ONGOING CLINICAL TRIAL 审中-公开
标题翻译：连续临床试验连续数据分析的系统与方法
公开(公告)号：WO2005031509A3
公开(公告)日：2006-05-26
申请号：PCT/US2004030922
申请日：2004-09-22
申请人： MEDIDATA SOLUTIONS INC , IKEGUCHI EDWARD F , DEVRIES GLEN M , SHERIF TAREK A
发明人： IKEGUCHI EDWARD F , DEVRIES GLEN M , SHERIF TAREK A
IPC分类号： G06Q50/00 , A61B5/00 , G01N33/48 , G06Q10/00
CPC分类号： G06Q50/24 , G06Q10/10 , G06Q50/22 , G16H10/20 , G16H50/70
摘要： System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researches because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.
摘要翻译：提供了持续分析正在进行的临床试验的试验数据的系统和方法。对包含受试者数据的试验数据库进行统计分析。如果统计分析的结果不超过预定阈值，则在临床试验正在进行时重复统计分析。在盲症临床试验中，在进行统计分析之前，从试验数据库和盲法数据库生成分组数据库。分组数据库根据研究组对主体试验数据进行分组。在试验进行期间，连续监测和分析试验数据与数据收集相关的统计学意义的能力为研究提供了许多好处，因为试验数据库不再成为获得有用结果的瓶颈，统计分析可以在近乎实时的基础上，而不必等到审判完成。

5. 发明申请

WO2005031509A2 SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF AN ONGOING CLINICAL TRIAL 审中-公开
标题翻译：连续临床试验连续数据分析的系统与方法
公开(公告)号：WO2005031509A2
公开(公告)日：2005-04-07
申请号：PCT/US2004/030922
申请日：2004-09-22
申请人： MEDIDATA SOLUTIONS, INC. , IKEGUCHI, Edward, F. , DEVRIES, Glen, M. , SHERIF, Tarek, A.
发明人： IKEGUCHI, Edward, F. , DEVRIES, Glen, M. , SHERIF, Tarek, A.
IPC分类号： G06F
CPC分类号： G06Q50/24 , G06F19/00 , G06Q10/10 , G06Q50/22 , G16H10/20 , G16H50/70
摘要： System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researches because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.
摘要翻译：提供了持续分析正在进行的临床试验的试验数据的系统和方法。对包含受试者数据的试验数据库进行统计分析。如果统计分析的结果不超过预定阈值，则在临床试验正在进行时重复统计分析。在盲症临床试验中，在进行统计分析之前，从试验数据库和盲法数据库生成分组数据库。分组数据库根据研究组对主体试验数据进行分组。在试验进行期间，连续监测和分析试验数据与数据收集相关的统计学意义的能力为研究提供了许多好处，因为试验数据库不再成为获得有用结果的瓶颈，统计分析可以在近乎实时的基础上，而不必等到审判完成。

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