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Data warehousing

Clinical Data warehouse and Analytics Console - CLIDAC is a secured, regulatory complaint Clinical Research Data Warehouse and Analytics System.

CLIDAC provides solutions with fact-based insights into clinical trial data, in order to assist your organization making informed business decisions, thereby helping your organization in increasing productivity and developing drugs in an effectivemanner, at a faster pace.

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What CLIDAC offers?

CLIDAC helps in

  • Standardization including SDTM transformation
  • Data reconciliation
  • Ongoing medical review
  • Safety monitoring and signal detection
  • Cross-study analysis
  • Single data storage for data mining and visualization
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a. Integrate and Load - Data

CLIDAC has out of the box integration capability to Connect and Load Data from

Clinical Systems
  • Oracle Clinical / RDC
  • RAVE
  • Open Clinica
  • Inform
Safety Systems
  • Argus
  • ArisG
Other Clinical or Safety Systems which runs on
  • Oracle database
  • SQL server database
File based data such as
  • Text / CSV
  • SAS – SAS datasets, XPT and CPT
  • XML – Including ODM XMLs
Documents and Images

CLIDAC has the capability to Load and Store Regulatory documents, Non-regulatory documents, Study documents, Site documents, Patient documents/images, Study deviation documents, Study mapping files in user defined study containers.

b. Transformation / Standardization

Using CLIDAC’s Transformation module, loaded source data can be converted to any target standards including SDTM standard using the UI based mapping features. CLIDAC supports custom transformations using SAS, Oracle and R programming languages.

Following are the components of this Module.

Standards library:-
  • SDTM standards are automatically available in the Standards library when there is a new SDTM version released by CDISC
  • SDTM and Company Standards shall be defined in the Standards metadata module
  • CLIDAC can be integrated with any MDR system to get the desired standards
Mapping Library:-

The list of target domain mapping stated below can be maintained in the Global library or at the Study library. System has the flexibility to be copy from study to study.

  • Source to target standard element mapping
  • The predefined derivations methods & contributing element
  • User defined derivation methods & custom programs

The list of target domain mapping stated below can be maintained in the Global library or at the Study library. The system has the flexibility to be copied from study to study

Transformation models:-

Transformation model is for defining the organization’s transformation levels. Mapping library elements can be defined based on the level of the element to be derived. This is user defined. Few example models are,

  • Review model
  • SDTM model
  • Once the user selects a target standard to which the study has to be transformed, the system does auto mapping of the tables and columns using mapping library
  • Any custom logics can be coded/copied from the mapping library. If the entire program has to be customized, the user can go with the Custom Transformation
Custom Transformation:-

Programmatic transformations can be done using Oracle PL/SQL or SAS or R programming.

c. Coding

Using CLIDAC’s Coding module, loaded source data/transformed data can be Coded, Recoded and Up versioned using MedDRA, WHODD or any other company dictionaries.

Following are the components of this Module.

Coding Library:-
  • MedDRA, WHODD, Company standard dictionaries, Synonym lists can be imported into CLIDAC’s coding library
  • CLIDAC can be integrated to any Coding systems or transactional system (like TMS and Argus) to Load/Get the dictionary data, synonyms into the coding library
  • Business users can configure the studies, the domains, and the dictionary to which the data has to be coded
  • Omissions and Coding change reports can be generated at the end of coding for review and action
  • Reassignments and Synonyms lists can be updated and it is possible to rerun the coding

d. Data Pooling

Using CLIDAC’s Data Pooling module, loaded source data/transformed data/coded data can be pooled/consolidated in a Standard area for reporting and analysis. This data can be used for

  • Cross-study analysis
  • Data mining
  • Single data storage for visualization
  • Reports and Analysis

e. Reconciliation

CLIDAC’s Reconciliation module can be used to reconcile clinical and safety data.

CLIDAC Analytics enables data exploration, analysis and data science driven predictive analytics to help your organization in monitoring and predicting risks at an early stage, in the clinical trial cycle:

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CLIDAC Automation and AI platform is designed specifically for the clinical trial enterprises. It applies advanced automation & AI algorithms to reduce man power, improve performance and save time. Notifications and follow-ups can be generated automatically without any human intervention using configurable workflow engine.

Sample workflow:-

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CLIDAC’s Collaboration module helps clinical trial users to Share any documents and data to Sponsors, Partners, Sites & CROs securely and instantly.

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