How can the NWORTH IT & Data Management team support your study?聽
NWORTH鈥檚 IT team work closely with study teams to effectively manage trial data 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 design in a manner to meet the needs of all end users, including study staff, analysts and participants. 聽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.聽
The IT team will support you with:聽
- eCase Report Form (eCRF) / CRF design
- Database design
- Data entry
- Data Management Plan (DMP) development聽
- Validation Master Plan (VMP) development
- Software validation, qualification and testing
- Data confidentiality and security聽
- Validation and testing
- User support and query resolution聽
- Data freezing & lock
Our NWORTH IT team have thorough knowledge of ICF Good Clinical Practice (GCP) and the UK regulatory framework for clinical trials, ensuring data is handled appropriately in line with the Data Protection Act 2018, General Data Protection Regulations (GDPR), GCP and other relevant legislation.