top of page

DATABASE (eCRF) DESIGN

Good Start.png

  • We design eCRFs in EDC systems, such as Medrio, ClinCapture, Medidata Rave and others

  • We incorporate ‘Quality by Design (QbD)’ principles when building databases i.e. program ‘Skip Logics’, ‘Warning Prompts’, ‘E-mail reminders’, ‘Subject Status’, ‘Custom Functions’, etc., such that it’ll guide site coordinator to enter only relevant data in the system.

  • We adhere to industry standards such as CDASH/CDISC and good documentation practices, version controls, when performing database build.

  • We set-up Lab module for ‘Local Lab’ CRFs, such that it’ll populate ‘Normal Ranges & Units’ for Local Labs.

  • We load requested versions of Coding dictionaries (MedDRA & WHO Drug dictionaries) in applicable CRFs.

  • We set-up ePRO (Patient Reported Outcomes) Questionnaires, add reminders and alerts for the patients, to achieve higher completion/participation from patients.

  • We set-up ‘User Rights & Roles’ and manage ‘User Access’ for the study team and site staff.

  • Troubleshoot any issues from sites, or resolve system deficiencies on Urgent basis.

DATA MANAGEMENT SOPs AND DOCUMENTS

Process_2.jpg

Click to Enlarge

Data Management SOPs

  • We follow simple, well-written processes that are intuitive, compliant and will make sense to you right away.

  • We’ve developed well-written SOPs that document how we will perform the DM tasks. 

    • And then, we adhere to our SOPs while performing those DM tasks, which ensure compliance to our SOPs.

Data Management Documents

  • Our DM documents are well-written, thorough and informative. And therefore, reduces the time needed for the study team to review and approve it. For e.g.

    • Data Management Plan (DMP)

    • CRF Completion Guidelines (CCGs)

    • Edit Check Specifications (ECS)

    • Dictionary Coding Plan

    • Data Transfer Agreements (DTA’s)

    • Data Review Plan (DRP)

    • SAE Reconciliation Plan

    • Study Close-out Checklist, and others

DATA AGGREGATION AND VISUALIZATION

Study Data.png
shutterstock_623665139.jpg

Data Aggregation (Repository)

  • Using Power BI, we can aggregate both the 'EDC data' and 'External data' to create a 'Data Repository' for the study.

    • And refresh these with latest data on periodic basis

  • By aggregating all study data ​in one central platform, we can;

    • Automate the Reports, Dashboards and Workflows for External Data Reconciliation etc. to gain holistic view of the data

    • Identify any data issues (for patient or sites) as soon as they're entered

Data Visualization

  • We use Power BI to create ‘Data Visualization’ that are easy to understand, relevant and therefore will be used by the study team.

  • These visualizations are ‘dynamic’ based on the filters you select, which makes it easier to comprehend your data.

  • We’ve created a ‘standard’ set of visualizations that’ll apply to most studies i.e. visualizations for Lab data, Vital signs, ECG, AE, Conmed’s etc. 

  • We can program ‘Custom/Ad-hoc’ visualizations based on your inputs & study needs.

bottom of page