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Execute Real Time Standards Management With iCLIMB.

ClinCafe proudly introduces -iCLIMB (Integrated Clinical MetaBase), a technology platform dedicated to managing Clinical Data Standards.

Execute Real-Time Standards Metadata Release Utilizing the iCLIMB Platform and Ensure High Standards Conformance in Clinical Trials

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iCLIMB AI Integration for Solving Complex Challenges

In iCLIMB, AI integration is strategically applied across following functionalities to address enduring challenges.

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Standards Governance In-Built Workflow

Built-in metadata workflow aims to reduce metadata release cycle time, enable effective review of in-process metadata, and expedite the availability of requested standards.

Additionally, the AI-driven algorithm empowers the standard library team to make data-driven decisions while reviewing and processing study requests, ultimately ensuring high standards conformance and satisfying organizational objectives.

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Integrated FDA and CDISC Guidance

For regulatory submissions, Sponsors & CROs must adhere to guidelines like FDA's Study Data Technical Conformance Guide & PMDA's Validation Rules. CDISC standards, which including Implementation Guides & TAUGs, CTs, are essential for efficiency.

Staying updated on evolving regulations is challenging. iCLIMB integrates guidelines into metadata processes, allowing users to focus on core tasks for compliant metadata development.

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ClinCafé - Who We Are

ClinCafé Consultancy Private Limited leads the way as a technology-driven company specializing in the implementation of clinical data standards

Our goal is to support clinical trials through our cutting-edge technologies, enabling efficient data processing and expedited submissions. Ultimately, we strive to accelerate the availability of life-saving medicines in the market.

Introducing the iCLIMB (Integrated Clinical MetaBase) Platform , a robust solution designed to facilitate the creation and implementation of Clinical Data Standards. With functionalities enabling the development of standards metadata that is F A I R:

  • Easily Findable
  • Directly Accessible
  • Seamlessly Interoperable
  • Highly Reusable

Thus Promoting Effective and Efficient Research.

iCLIMB (Integrated Clinical MetaBase) Platform

iCLIMB, our Integrated Clinical MetaBase platform, is a cutting-edge standards implementation tool with advanced standardization capabilities. The objectives of iCLIMB is to address the following challenges in Clinical Metadata Management Systems:

  • Fragmented metadata across disparate platforms and channels.
  • The absence of a knowledge-driven intelligent system to facilitate standards implementation.
  • Prolonged release cycles of standard libraries leading to increased creation of study-specific standards.
  • Insufficient validations aligned with CDISC and FDA guidelines.
  • Limited innovation and integration of AI in standards development.

Why iCLIMB?

In the contemporary landscape of metadata management systems, there arises a critical need for a platform that not only handles metadata but also comprehends clinical data standards such as SDTM, CDASH, and ADaM, embodying a built-in standardization ethos. This platform should possess the capability to guide users in crafting efficient standards adhering to the F A I R principles (Findable, Accessible, Interoperable, Reusable). Achieving excellence demands integration with CDISC and FDA guidelines, augmented by AI-driven self-learning mechanisms.

At ClinCafé, we recognize these imperatives and have developed one of the most robust technological platforms for metadata management. Our solution transcends conventional boundaries, striving for excellence in the realm of standardized metadata management.

Ensure timely delivery, every time.

Integrated workflows facilitate the prompt release of library metadata and real-time change request processing.

Exceptional quality

Incorporating FDA and CDISC metadata checks enables the creation of high-quality metadata.

Optimized Onboarding Time

Our simple and intuitive design ensures that teams can get started swiftly and effortlessly.

Innovation Beyond Imagination

Discover innovation that transcends your imagination with our aCRF and standards metadata modules.

What benefits can you expect from the iCLIMB Platform?

Unlock the potential of End-To-End Standardization with iCLIMB.

iCLIMB consists of the following modules for Standards Implementation and Delivery:

SDTM Annotated Case Report Forms (aCRF)
Standards Metadata (IG / Model / CT)
Biomedical Dictionary
External Data Sources

aCRFPRO Module

SDTM Annotated Case Report Forms (aCRF)

  • Revolutionize SDTM Annotation Management
  • Effortlessly Produce High-Quality SDTM Annotations at Unprecedented Speed
  • Cut aCRF Preparation Time by Over 80%
  • Get submission ready aCRF PDF with different levels of bookmarkings with just click of a button
  • Take advantage of diverse functionalities including AI annotation prediction, synchronization of annotations from library/study, annotation validation, and simulate SDTM based on annotations.
  • Export the entire CRF design along with annotations and SDTM metadata in various file formats such as Excel, PDF, and CSV.

Tabulation Standards

Manage IGs Models and CTs Standards

  • Effortlessly integrate with CDISC SDTM Models and IGs to ensure efficient data management practices.
  • Streamline the creation and oversight of standards.
  • Optimize insights and decision-making by tailoring standards implementations based on sponsor’s needs.
  • Improve efficiency and collaboration with a built-in workflow.
  • Ensure compliance with the latest industry standards for submission readiness.

Biomedical Dictionaries

Biomedical Concept Dictionaries

  • Integrate with the SDTM metadata library and controlled terminologies to maintain biomedical concept dictionaries for different data streams.
  • Gain deeper insights into biomedical concepts through visual concept diagrams, enhancing comprehension of concept constructs.
  • Utilize the built-in concept validator for high-quality metadata creation.
  • Effortlessly transfer data to and from the controlled terminology module, ensuring smooth data synchronization.
  • Facilitate collaboration and information sharing with stakeholders to drive informed decision-making and efficient project execution.

External Data Sources

Vendor Data Transfer Structure

  • Utilize the SDTM metadata library and controlled terminologies to establish and manage standardized External Data Sources (EDS).
  • Efficiently adapt relevant EDS from the libraries and customize them to meet the study specific requirements.
  • An integrated digital sign-off and approval process accelerates approvals and enhances collaboration between sponsors and vendors.
  • Facilitate collaboration with vendor and faster aggreement finalization.

aCRFPRO Module

SDTM Annotations for Case Report Forms (aCRF)

  • Revolutionize SDTM Annotation Management
  • Effortlessly Produce High-Quality SDTM Annotations at Unprecedented Speed
  • Cut aCRF Preparation Time by Over 80%
  • Get submission ready aCRF PDF with different levels of bookmarkings with just click of a button
  • Take advantage of diverse functionalities including AI annotation prediction, synchronization of annotations from library/study, annotation validation, and simulate SDTM based on annotations.
  • Export the entire CRF design along with annotations and SDTM metadata in various file formats such as Excel, PDF, and CSV.

Tabulation Standards

Manage IGs Models and CTs Standards

  • Effortlessly integrate with CDISC SDTM Models and IGs to ensure efficient data management practices.
  • Streamline the creation and oversight of standards.
  • Optimize insights and decision-making by tailoring standards implementations based on sponsor’s needs.
  • Improve efficiency and collaboration with a built-in workflow.
  • Ensure compliance with the latest industry standards for submission readiness.

Biomedical Dictionaries

Biomedical Concept Dictionaries

  • Integrate with the SDTM metadata library and controlled terminologies to maintain biomedical concept dictionaries for different data streams.
  • Gain deeper insights into biomedical concepts through visual concept diagrams, enhancing comprehension of concept constructs.
  • Utilize the built-in concept validator for high-quality metadata creation.
  • Effortlessly transfer data to and from the controlled terminology module, ensuring smooth data synchronization.
  • Facilitate collaboration and information sharing with stakeholders to drive informed decision-making and efficient project execution.

External Data Sources

Vendor Data Transfer Structure

  • Utilize the SDTM metadata library and controlled terminologies to establish and manage standardized External Data Sources (EDS).
  • Efficiently adapt relevant EDS from the libraries and customize them to meet the study specific requirements.
  • An integrated digital sign-off and approval process accelerates approvals and enhances collaboration between sponsors and vendors.
  • Facilitate collaboration with vendor and faster aggreement finalization.

Product Pipeline - What's Next?

EDC Metadata Management

EDC Metadata Management will be added a module in iCLIMB Platform. This will complete the end to end metadata management process.
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In-development

MVP by end of Q3, 2024

AI Test Data Generation

AI Test Data Generation will be our first open source project . It will immensely expedite the setup of downstream clinical programming and medical review visuals. Know More

Planned

First Prototype by Q2 2025

Smart TDD (Trial Design Datasets)

The Smart TDD will be an innovative addition to the iCLIMB Platform, wherein trial team will be able to create and store Trial Design Domain from the protocol. Know More

In-development

First Release By Q1 2025

Contact Us

Get in touch with our team to learn more about ClinCafé Products

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