Flask Data Management

Data management

Assure high quality data for statistical analysis

Data management plan

The clinical data management plan, starts with developing a robust data model according to the protocol.

The data model is designed to efficiently serve GCP monitoring of the study and fit the needs of the statistical analysis of the results. The data model design is a team activity led by a Flask Data project manager with you and the study statistician. The output of the data model design is a specification which is version controlled and updated based on clarifications and/or requests received from the customer. The data model specification also serves as a basis for quality control of the study build.

The team then decides what real-time data tools they need for clinical data and safety monitoring, patient compliance monitoring and site performance to service level objectives for data collection.

Data management build process

eCRF built using the Flask Forms visual designer. Variable names are assigned using CDASH conventions. Annotated CRFs are available online in the Flask CTMS.
Edit checks per form or between forms
AE/SAE reporting
Study configuration – describe the study meta-data, site information, user information
Edit check specification: A complete list of online edit checks and manual review checks is prepared as applicable. The list will be reviewed and approved by the Sponsor before implementation.
Beta UAT instance: A prototype UAT instance implements the data model with online edit checks and custom programming. Once approved, further changes to the UAT will be restricted and may result in delays and extra costs.
Final UAT (with online edit checks and custom functions): represents the complete study build. All changes requested by the customer have also been implemented.

Data management subscription

During the study, your stakeholders all have access to the real-time data tools on-demand,. Real-time clinical data management reports, compliance alerts and analytics are part of your Flask Data unlimited usage subscription. Flask Data Digital CRO enables you to continuously monitor and assure GCP compliance in your studies:

Real-time, online data tools that operate directly on the raw EDC, ePRO and device data, without requiring data extracts and manual processing. Real-time tools can process multiple sources – such as biomarkers from lab data, ECG, eCRF, and dosing and highlight GCP compliance issues.
Automated, real-time alerts fire independently of EDC edit checks, DM reports and CRA queries
Automated DSMB reporting
Automated processing of site performance

Interim and final statistical analysis

The process of continuous data clean brings the study team to objective of study: testing and validating the scientific hypothesis of the experiment. Flask Data provides validated CDISC-standard data extract formats including ODM XML 1.3, CSV and SDTM/ADaM data set preparation.