Sharing CTMS Data Between Sponsors and CROs
| June 21, 2012 |
Virtual/Webinar/Webcast
There is a clear trend in the health sciences industry toward outsourcing clinical trial management to clinical research organizations (CROs). If your organization is considering outsourcing, or already does so, there are different methods that pharma and medical device companies can use to collect clinical trial management system (CTMS) data from their CRO partners. Read more »
Many companies have made great strides in standardizing and conforming subject data collected in clinical trials, in order to have a more efficient and repeatable way of delivering the data to reporting systems for statistical analysis and regulatory submissions.
This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Trying to build a business case for a clinical trial management system (CTMS) at your organization? Let us help you! BioPharm Systems’ Clinical Trial Management Solutions practice has decades of experience with CTMS implementations for organizations of all sizes. Over the years, our clients have told us the ways in which having a CTMS has benefited them, and we would like to pass the top ten on to you.
Oracle Clinical (OC) / Remote Data Capture (RDC) 4.6 provides the ability to conduct global clinical trials more efficiently and effectively. The newest release features significant enhancements that enable and support complex study design scenarios.
Siebel Clinical is well-known as a robust clinical trial management system (CTMS) that streamlines clinical trial management. The system can be operated uniquely by users in various roles at sponsor and clinical research organizations.