Frequently Asked Questions (FAQ)
How do I get started on your platform?
How do I get started on your platform?
You can sign up for an account here.
How much does it cost to use your tool?
When you first create an account with us, you have 14 days of unlimited use as a free trial. Contact us here for more details.
What can your tool do?
What can your tool do?
The “birds eye view” is that our tool performs automated data management and biometrics tasks. We can support Database Lock analysis and Risk-Based Quality Management (RBQM), and biometrics tasks such as creating Tables, Listings and Figures for a clinical study report (such as Baseline Characteristics, Adverse Events and ConMeds).
What is the general flow or rhythm of your tool?
You first upload your data file to one of our tools (Describe Baseline Characteristics for study demographic analysis, for example); our system automatically identifies the type of data with or without additional input from you; it then summarizes the results–it computes descriptive statistics, summaries, and even statistical significance tests. If appropriate, it will compare the results across time or across cohorts. Readout automatically describes the findings with a paragraph for each table of results.
What format does my uploaded data need to be in?
ADaM or StDM data or a single sheet spreadsheet (lock file, an export from eDiaries, recruitment portals, etc.) Once you have an active account with us (login), you can also gain access to our synthetic data files as testers for our tool.
Do these single sheet spreadsheets have to be in specific formats?
Yes; .xls, .xlsx, .csv – You can export these from your EDC.
What about data and security?
What happens to the data that I upload?
The data that you uploaded is analyzed and then deleted. Our tool is transactional in that it only scans the data for the task it needs and then it’s discarded – we never store your input data. Your results can be saved in PDF, Word, or Excel, and as a Notebook–you can learn more about Notebooks once you have an active account with us! (login)
How secure is the data that I upload?
We take your privacy and data security seriously – we never store any of your data on our servers. Your information is safe with us – it’s uploaded, it’s analyzed, and it’s gone. In addition we follow regulations such as 21 CFR Part 11 and GDPR.
How secure is my account?
We comply with best practices in cybersecurity to keep your account safe, and we follow regulations such as 21 CFR Part 11 and GDPR.
Can you teach me or can I try to learn myself?
Do you have a video that generally introduces your tool?
This is coming soon! In the near future we will have a video that gives an overview on how our tool flows!
I would like to learn by trying the tool out myself. Do you have example data to work with?
Yes! You can gain access to the downloadable link to the example data batch, which contains synthetic data sets and step-by-step instructions on how to run each tool with the synthetic data sets, once you have an active account with us! (login)
