Data Management for Clinical Trials

Database Development

Clean and accurate data will allow your questions to be answered but all questions are asked in different research and business environments.

Does the database need to meet FDA or TGA requirements or is it a marketing based study that would benefit from the adoption of the ICH GCP Guidelines but does not need the rigor or expense of a fully compliant FDA database? Is MedDRA, WHODD, WHOART, COSTART or ICD-9 most appropriate.

Statistical Revelations can help you decide on the correct approach and better data management.

Statistical Revelations can then design and build the database that ensures that your data are stored in the most appropriate and cost effective manner.

Data Capture

For correct Data Management - Should you use double data entry, scanning, fax, email or develop an eCRF?

It depends!

What is the profile of the team capturing the data?

Statistical Revelations will help you decide on the right approach and can implement any one or a mix of data capturing solutions for you in a concise and cost effective manner.

Data Cleaning

The data has been captured and the hard job is done.

Wrong!

At times up to 70% of the costs involved in data management are targeted at ensuring that the data that have been captured are recorded so that they accurately depict what happened.

Statistical Revelations use inbuilt range checks to ensure, for example that 2 meter tall 14 year olds are not readily accepted but isolated for investigation. Cross validation of fields means, as an example, that any pregnant males are easily identified and the recording physician contacted.

The tracking and validation of data to ensure they will be clean is what the data management team is all about.

Data Management - Reporting

None of us work in a vacuum and you will always want to know what is happening in your study. Statistical Revelations encompasses not only your traditional review meetings and action plans but provides 24/7 secure access to our systems so that when you need the information you can get it.

Makes it easier to work those late nights!

Some of our clients also use our online analysis system to perform their own simple analysis or run queries against their own data, making information flow between you, the client, and Statistical Revelations secure and easy.