Development Sprint Period #4 from 29th March to 30th April
The team at ClinTex have been able to accelerate development of the CTi platform, achieving much in this sprint. CTi-OEM is ontrack to be delivered during the last week of June/first week of July. The development team has been focused on the integration of 5 key data domains that are now compliant with SDTM clinical data standards. Progress has been very good on the development of specifications and the deployment of visualisations as per CTi-OEM functional and design requirements.
This sprint concluded with CTi-OEM Package updating to the 19th version of CT1_v0.19 on 29th April 2021 for testing. Much of the progress achieved in this sprint was integrated into version 19. The following functionality was added:
- Development and onboarding of data sources in SDTM format for:
- Patient Demographic Data
- Query Data
- External Data
- Visit Data
- Patient Screening Failures
2. Deployed CTi-OEM Visuals: Visualisation Specifications have been developed and 15 sets of visualisations have been developed for onboarded clinical trial data, including:
- Query Performance — 4 Sets of Visual Analytics
- Data Entry Performance — 2 Sets of Visual Analytics
- External Data — 3 Sets of Visual Analytics
- Patient Enrolment — 3 Sets of Visual Analytics
- Screen Failures. — 3 Sets of Visual Analytics
Development and Onboarding of Data Sources
See below: DM DOMAIN — Demographic Data (One example of the 5 data domains onboarded into CTi during this sprint)
Developing and onboarding data sources in SDTM is very important for clinical trial software. SDTM, or Study Data Tabulation Model, is a standard used for organizing data collected in human clinical trials. The Clinical Data Interchange Standards Consortium (CDISC) developed STDM so that when parties collected disparate data from trials, it could be converted into a specific table format such that anyone could interpret it. Before SDTM, there were a variety of organizing and naming regimes that forced reviewers of data to spend non-trivial amounts of time composing data so that it made sense to them. Such inefficiency ultimately prolonged the clinical trial process, which made it more expensive.
SDTM is the data structure that is required as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). For business clients using the CTi platform, having platform access to STDM formatting is crucial.
Deployed CTi-OEM Visuals
One of many visualisations added during Sprint #4. This is a visualisation to display total cumulative enrolment, enrolment by country and enrolment by site.
Next Sprint # 5 31st April 2021 to 21st May 2021
During the next sprint, onboarding of further CTI-OEM datasets in SDTM format will continue over the coming weeks. The following features began development in sprint #4, will continue to be developed, and in the next sprint the features will be completed:
- CTi-OEM Visuals in Development: Development is ongoing and is on track with a development roadmap for onboarding data sources and visualisation development for the following key analyses:
- Adverse Events
- Protocol Deviations
- Baseline Failures
- Site Monitoring
- Patient Completers
2. CTi-OEM Dashboards in Development: Development is ongoing and is on track for deployment of the all CTi-OEM dashboards by 1st week in July 2021. These dashboards are:
- Clinical Study Performance Dashboard
- Clinical Data Management Dashboard
- Site Monitoring Dashboard
We look forward to bringing you more updates on upcoming CTi-OEM Sprints in the coming weeks as the project progresses.
ClinTex are a solution provider to the pharmaceutical industry, and the team behind CTi — Clinical Trials Intelligence: a new type of software platform aimed at transforming the medicine development industry through the application of predictive analytics, machine learning, and the novel use of blockchain technology and smart contracts in clinical trials.
Our mission is to bring down the cost of medicine and improve the speed to market of new medicines for the people who need them, through vastly reducing development costs for the global pharmaceutical industry.
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