How can the NWORTH Information Systems (IS) team support your study?
NWORTH’s IS team work closely with study teams to offer solutions for capturing electronic data in trials and ensure data integrity from the point of entry, to management, through to data lock. We design trial software, databases, and systems (e.g. Electronic Data Capture system, Randomisation system), ensuring these are designed in a manner to meet the needs of all end users, including study staff, analysts and participants. We validate every system to provide study teams with a high degree of assurance that the system will consistently meet its predetermined specifications and quality, and will be fit for purpose in line with Good Clinical Practice (GCP). Our validation process is ongoing, meaning that we continuously review to make sure the system remains in a validated state throughout its lifetime.
The IS team will support you with:
- eCase Report Form (eCRF) / CRF design
- Database design
- Data entry
- Software validation, qualification and testing
- Data confidentiality and security
- User support and query resolution
- Data freezing & lock
Our NWORTH IS team have thorough knowledge of Good Clinical Practice (GCP), the UK policy framework for clinical trials, and Clinical Trial Regulations, ensuring data is handled appropriately in line with the Data Protection Act 2018, General Data Protection Regulations (GDPR), GCP and other relevant legislation.