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病患特征统计分析 What is Patient Profiles? Patient profiles is a Windows based software application designed specifically to allow users to spend time looking at their data rather than programming or formatting tasks. It generates One Page report.
Patient Profiles is a visual tool for displaying clinical trial data and medical registry data. Clinicians and other non-statisticians can view and search clinical trial patient data with no programmers, no statisticians and no waiting.
Produce a Profile Design in under an hour.
Import all data formats (Oracle, SAS, Microsoft Excel, CDISC).
Customize the profiles to suit your needs, see examples.
Generate Adverse Event narratives, patient timeline, graphs and tables.
View and search live data.
Save profiles as Microsoft Word, PDF or HTML files.
Produce a Web-Viewer for sharing the finished profiles.
Open from any internet browser.
Viewers don’t need access to the data or the Patient Profiles software.
Share with team members, clients and principal investigators.
Viewers can sort and search profiles.
Send us the data and we’ll produce the profiles for you.
Audit your CRO by checking enrollment status and data quality.
After a brief consultation with you, we’ll produce your profiles and provide them to you in PDF, MS Word and our searchable, hyperlinked Web-Viewer format.
Test the profiles on your team, and we’ll edit the profile design to the team’s exact specifications.
Update the profiles as often as needed.
Features
Easy Set-Up: The Patient Profiles interface makes setting up the profile design easy. The profiles can be set up in as little as 30 minutes for a Phase 1/2 trial. Typically, it takes about 1-2 hours to set up a detailed profile for a large longitudinal Phase 3 trial with many datasets such as adverse events, concomitant meds, lab values and efficacy data and many features (such as normal limits for labs and color coding for severity of adverse events). No programming knowledge is necessary. No reformatting of data structure prior to import is necessary.
Import SAS Format Catalog: In addition to SAS variable labels, format files can now be imported directly into our program. The labels and formats make the data more "readable" by using descriptive words and phrases to name the variables and the values within the variable.
Automated Adverse Event Narratives: Serious Adverse Event (SAE) narratives are easily generated with just a few extra clicks.
Compare Time Trends Across Subjects: Locate/search for outliers or patterns over time by looking at individual graphs of all patients at once.
Profiles Can Be Annotated: The program allows you to annotate the profiles while still in the program and save the annotations for others to view. Reviewers (who don’t have access to the program) can also annotate the profiles in Word.
Profile Scheduler: After completing a design of a profile template, you can schedule the program to run the design on a regular basis. The program will save the profiles for you to view later.
Copy and paste: The profiles are in a tabular format. When they are saved as a Word file, portions of each profile (graphs and/or tables) can be copied and pasted into other documents or programs (such as Excel and PowerPoint).
Automatically Updated : As new clinical data comes in, the program automatically updates the profiles.
Search/sort capability: The profile creator can define queries (such as a lab value being too high, a serious AE occurring, or a combination of different characteristics and events). When viewing the profiles both within the program and the web-viewer, you can sort and search them based on these pre-specified queries.
Profile Design Can Be Saved and Shared: The program enables you to create, store and modify a profile design and allows others to open up, modify and re-run the profile design to obtain more recent and/or different information. The program records the data and calculations used in generating a profile so that viewers can refer to it if necessary. The design file is a XML file and can be attached to an e-mail.
Accepts All Data Structures: The program recognizes the long/skinny and short/wide types of data structures. The program can graph data from both types of datasets without any reformatting from the user. This is a useful feature for CROs that often have datasets with different structures depending on the client’s needs.
Hide/Unhide Data: The program can easily "hide" data in one version of a profile and display it in another. This is useful to provide output to clients, members of data monitoring committees, and primary investigators in blinded studies.