Software solutions for automatic bulk import of adverse event data, from existing clinical trial databases to the clinicaltrials.gov XML format, can dramatically streamline the basic results reporting process for clinical studies. The first task of publishing a clinical study to the clinicaltrials.gov web site is the submission of the clinical study protocol registration data, after which the reporting of basic results becomes necessary. Basic results data for the clinical study should be reported on an ongoing basis, per the terms of registering clinical research trials with the FDA and CT.gov web site. Although reporting of basic results (which includes adverse events and SAEs) is a time-consuming data entry process, a streamlined software solution, via a bulk adverse event extraction and upload system, can greatly expedite and autom ....]]> Wed, 25 Apr 2012 13:15:22 GMT http://www.medphasesoftware.com/Convert-Clinical-Trial-Basic-Result-19 Contact us with your questions or software development needs.

Clinical trials basic results information is required by law to be reported to the FDA ClinicalTrials.gov web site, as of September 2008. All clinical trial basic results data for FDA-approved clinical trials should be reported. This covers both FDA regulated clinical studies, drugs, and medical devices. Due to the volume and/or complexity of clinical trial basic results data, software may be used to convert basic results Excel spreadsheets into ClinicalTrials.gov basic results XML for uploading to the PRS Protocol Registration System web site. With MedPhaseSoftware solutions, software can be integrated with external data sources to generate and author the required XML to support basic results submission requirements for ClinicalTrial.gov.Typically, basic results information from a clinical study includes several pi ....]]> Wed, 06 Jul 2011 20:15:35 GMT http://www.medphasesoftware.com/ClinicalTrialsgov-Login-Registratio-18 Contact us with your questions or software development needs.

Download a free trial of Clinical Trial Submit to visually create and edit ClinicalTrials.gov XML files.

ClinicalTrials.gov is the official repository for hosting clinical trial protocol registration, summaries, and study results data. Clinical trials may be searched and located by using the protocol registration system PRS web site interface or by using URL command line XML searches, specified by the clinical trials gov XML schema and DTD. Usage of the ClinicalTrials.gov web site for publishing protocols and study results requires a ClinicalTrials.gov login and identifier. Once a clinical trials gov login is obtained, users may access the PRS web site for entering of protocol registration information and study results data. Data may be entered using the ClinicalTrials.gov web site interface or by uploading clinical trials ....]]> Tue, 10 Aug 2010 16:42:37 GMT http://www.medphasesoftware.com/ClinicalTrialsgov-XML-Schema-17 Contact us with your questions or software development needs.

Download a free trial of Clinical Trial Submit to visually create and edit ClinicalTrials.gov XML files.

Clinical trial studies and protocols may be submitted and published on the ClinicalTrials.gov Protocol Registration System by using the ClinicalTrials.gov PRS web site interface or by using the ClinicalTrials.gov XML Schema. The clinical trials .gov XML schema allows for uploading and downloading (importing and exporting) clinical trial protocol registration data to and from the ClinicalTrials.gov protocol registration system. By using the ClinicalTrials.gov XML schema when exporting, the user can download an XML file, containing all prior entered protocol registration data. By using the ClinicalTrials.gov XML schema when uploading (importing), the user can create all necessary clinical trial registration data in an XML ....]]> Tue, 10 Aug 2010 16:38:27 GMT http://www.medphasesoftware.com/Clinical-Trial-Submit-Documentation-16 Introduction Clinical Trial Submit is a desktop software application that allows you to create and edit ClinicalTrials.gov XML files, for uploading to the ClinicalTrials.gov (PRS) Protocol Registration System web site. Clinical Trial Submit helps to greatly reduce the time it takes to enter clinical trial study protocol information while manging clinical studies listed with the FDA's online Clinical Trials.gov protocol registration system. With the powerful ability to import existing ClinicalTrials.gov XML files or create new ones from scratch, Clinical Trial Submit allows you to easily keep your protocol registration information updated, in a convenient and secure solution. Clinical Trial Submit is a must-have tool for working with the ClinicalTrials.gov protocol registration web site. About the Full Version Clinical Trial Submit is available as a FREE 20-Day trial. The trial version is fully functional and can be us ....]]> Sat, 07 Aug 2010 21:20:40 GMT http://www.medphasesoftware.com/Publishing-Clinical-Trial-Protocols-15 Contact us with your questions or software development needs.

Download a free trial of Clinical Trial Submit to visually create and edit ClinicalTrials.gov XML files. The ClinicalTrials.gov web site is a central web location by the United States FDA for maintaining and publishing clinical trial protocol and study result information in a web-based format. ClinicalTrials.gov provides a web interface for entering clinical trial protocol data information as well as an XML upload/download and import/export capability for managing clinical trial protocol data using outside methods, software applications, and products, such as the visual ClinicalTrials.gov XML editor, Clinical Trial Submit.

The ClinicalTrials.gov ....]]> Sat, 07 Aug 2010 20:17:47 GMT