The database development and data management team specialises in designing and developing electronic case report forms (eCRFs) for a range of research projects.
It helps to ensure compliance with the requirements of the study protocol, sponsor quality standards, ethics and regulatory bodies.
We initially carry out a rigid validation process which is compliant with good clinical practice and UK clinical trials regulations.
We then set up and test databases that are tailored to the data capture needs of the project.
The MedSciNet clinical trial framework serves as a powerful tool in enabling us to meet the requirements of multisite research projects.
The framework facilitates the creation of bespoke eCRFs that allow participating centres to enter their data securely online.
It also offers varying access rights, for tasks such as data entry or monitoring, and query facilities for trial managers.
The framework is customisable and enables eCRFs to be developed that meet the exact requirements of the project. It is also easy to use and ensures secure online data entry.
Data output is provided in standard format for processing in Excel or in Access if needed and for statistical analysis in, for example, Stata, SAS and SPSS.
Data management services go beyond the eCRF creation process and also include:
• Data planning – how data will be handled throughout the study duration, data lock processes and storage of data for future use
• Paper case report forms
• Management of complex data management solutions for different types of research projects.
The services provided range from advice on data management strategies to implementing complete data management solutions.
The database development and data management team works in close collaboration with trial statisticians, trial managers and principal investigators.
The team ensures eCRFs, data management plans and other specialist data management strategies provide accurate and complete data that can be analysed confidently.
Our database packages include:
• Bronze: Up to 15 unique CRF pages
• Silver: Up to 30 unique CRF pages
• Gold: Up to 50 unique CRF pages.
Appropriate costs for database development and data management services will need to be included in your grant application.