Self-Service Clinical Data Solutions

Unlock the information and help realize value of
clinical data across clinical development value chain

Data, Analytics, Insight…Faster

Self-Service Clinical Data Solutions

Unlock the information and help realize value of clinical data across clinical development value chain

Data, Analytics, Insight…Faster

GET EASIER, FASTER, AND SECURED ACCESS

Supported by various self-service data solutions, get an easy, instant and reliable access to all Clinical R&D Data.

All integrated data is available to clinical data management and power analyst end users in Clinical R&D processes via a secured cloud-based offering.

EMPOWERING CLINICAL DATA AND STANDARDS MANAGEMENT WITHIN CLINICAL R&D

Leverage Clinical Data Solutions to get easier access to all clinical R&D data via a single source of truth.
Supports small to large data sizes and user base with required performance & scalability. Efficient, faster time-to-value, reliable, and allows end users to focus on the business value of data rather than IT. It is all in cloud, secured and big data enabled!

Clinical Data Repository

Overview
A cloud-based, configurable and homogenous computing platform, Clinical Data Repository (CDR) leverages existing investments by integrating, exchanging and analyzing clinical studies data as per industry business needs. It manages data assets in a centralized & controlled manner, thereby improves ability to access meaningful data timely & efficiently via “single-source-of-truth”.

Key Features
Some key features of CDR include data transformation, standardization, validation and quality management, instream metadata repository, various data types and formats support, audit trail and traceability, role-based access controls, blinding & unblinding, version control, change management, big data support, and completely validated and 21 CFR Part 11 compliant.

Key Differentiators
A single, scalable, and integrated solution that is implantable in one project that is a one stop solution for data, metadata, reporting and analytics.

User Benefits
CDR enables integration of data from different sources with different formats and improves the accessibility of meaningful data in the desired format for the clinical end users.

CLINICAL DATA QUALITY MANAGEMENT & ENRICHMENT SOLUTION

Data Validation & Quality Management
The solution offers a built-in library of standard validation checks and support for building custom validation checks in the non-programmatic fashion which improves efficiency and quality management.

Data validation engine
The data validation engine carries out discrepancy checks for data, enabling the validation of data fields for missing data, duplicate records, data outliers, and inconsistent data. It offers built-in support to CDISC standards for all versions, compliance to regulatory standard checks as well as ability to build custom checks. Get discrepancy management workflow with an ability to create, track, and resolve.

Data Coding and Enrichment
The solution has Automated Medical Coding with built-in coding libraries MedDRA, WHO, and Ontologies. Self-intelligence to capture manually coded terms for future auto-coding; review and approve workflow.

Key Differentiators
This completely validated and 21 CFR Part 11 compliant, completely web-based and collaborative solution offers the unique ability for non-technical or techno-functional users to take advantage of its end-to-end process flows, data flows, and workflows.

METADATA REPOSITORY

Overview
An integral part of the E2E data and workflow streams, Metadata Repository (MDR) handles standardized metadata under clinical and healthcare domains such as SDTM, ADaM, CDASH, ODM, PRM, LAB, SEND, hl7, BRIDGE, i2b2 etc. It is a platform that integrates with multiple third party tools and metadata sources.

Features
Some key features of MDR solution include Metadata persistence model, Metadata Repository Integration API, Metadata life cycle management, built-in regulatory compliance, model independent repository, CDISC SHARE support, concept-based study build, library management, version control, automated change impact analysis, and role-based access controls. Built-in compliance to ISO/IEC 11179 standards.

Key Differentiators
MDR’s ability to efficiently manage INSTREAM Enterprise level E2E processes and audit trails from a metadata perspective and interface with MaxisIT’s integrated platform products as well as third-party products. Out-of-the-box integration with Medidata Rave Study Designer with ALS support.

User Benefits
MDR enables integration across heterogeneous systems maintaining the integrity of metadata. It also increases interoperability between applications, tools and services, reusability of modules, systems and data.

CLINICAL DATA INTEGRATION & STANDARDIZATION SOLUTION

Overview
A completely metadata-driven, drag-n-drop data integration, transformation, and standardization solution, which offers huge reusability and drives automation with required collaboration, control, and scalability. It supports both ETL / ELT models for data transformation and aggregation.

Features
The key features of this solution include built-in metadata repository, Integration-as-a-service framework for third-party data sources integration, standardization tool, drag-n-drop data mapping, simple to complex data transformation management, import/export in multiple data types and format, and configurable data validation engine with library of OpenCDISC compliance checks; one-click Define.xml generator, change impact analyzer, data dependency analyzer, and version control; end-to-end data integration, transformation, and loading workflow automation with the ability to schedule the process and monitor, alerts & notifications, process manager, built-in intelligence for auto-mapping, role-based access controls, and collaborative workflows – all configurable & reusable.

Key Differentiators
A highly scalable, performance oriented, completely validated and 21 CFR Part 11 compliant solution; it provides a unique ability for non-technical or techno-functional users to take advantage of its end-to-end process flows for the most efficient way of standardizing clinical data for regulatory submission and/or transforming & aggregating data for analytics.

User Benefits
End users ability to bring in study data in the most effective and efficient manner with required traceability and manageability. Minimum to No programming needed; completely self-services.

+ Clinical
Data Repository

Clinical Data Repository

Overview
A cloud-based, configurable and homogenous computing platform, Clinical Data Repository (CDR) leverages existing investments by integrating, exchanging and analyzing clinical studies data as per industry business needs. It manages data assets in a centralized & controlled manner, thereby improves ability to access meaningful data timely & efficiently via “single-source-of-truth”.

Key Features
Some key features of CDR include data transformation, standardization, validation and quality management, instream metadata repository, various data types and formats support, audit trail and traceability, role-based access controls, blinding & unblinding, version control, change management, big data support, and completely validated and 21 CFR Part 11 compliant.

Key Differentiators
A single, scalable, and integrated solution that is implantable in one project that is a one stop solution for data, metadata, reporting and analytics.

User Benefits
CDR enables integration of data from different sources with different formats and improves the accessibility of meaningful data in the desired format for the clinical end users.

+ Clinical Data Quality
Management & Enrichment Solution

CLINICAL DATA QUALITY MANAGEMENT & ENRICHMENT SOLUTION

Data Validation & Quality Management
The solution offers a built-in library of standard validation checks and support for building custom validation checks in the non-programmatic fashion which improves efficiency and quality management.

Data validation engine
The data validation engine carries out discrepancy checks for data, enabling the validation of data fields for missing data, duplicate records, data outliers, and inconsistent data. It offers built-in support to CDISC standards for all versions, compliance to regulatory standard checks as well as ability to build custom checks. Get discrepancy management workflow with an ability to create, track, and resolve.

Data Coding and Enrichment
The solution has Automated Medical Coding with built-in coding libraries MedDRA, WHO, and Ontologies. Self-intelligence to capture manually coded terms for future auto-coding; review and approve workflow.

Key Differentiators
This completely validated and 21 CFR Part 11 compliant, completely web-based and collaborative solution offers the unique ability for non-technical or techno-functional users to take advantage of its end-to-end process flows, data flows, and workflows.

+ Metadata
Repository

METADATA REPOSITORY

Overview
An integral part of the E2E data and workflow streams, Metadata Repository (MDR) handles standardized metadata under clinical and healthcare domains such as SDTM, ADaM, CDASH, ODM, PRM, LAB, SEND, hl7, BRIDGE, i2b2 etc. It is a platform that integrates with multiple third party tools and metadata sources.

Features
Some key features of MDR solution include Metadata persistence model, Metadata Repository Integration API, Metadata life cycle management, built-in regulatory compliance, model independent repository, CDISC SHARE support, concept-based study build, library management, version control, automated change impact analysis, and role-based access controls. Built-in compliance to ISO/IEC 11179 standards.

Key Differentiators
MDR’s ability to efficiently manage INSTREAM Enterprise level E2E processes and audit trails from a metadata perspective and interface with MaxisIT’s integrated platform products as well as third-party products. Out-of-the-box integration with Medidata Rave Study Designer with ALS support.

User Benefits
MDR enables integration across heterogeneous systems maintaining the integrity of metadata. It also increases interoperability between applications, tools and services, reusability of modules, systems and data.

+ Clinical Data Integration
& Standardization Solution

CLINICAL DATA INTEGRATION & STANDARDIZATION SOLUTION

Overview
A completely metadata-driven, drag-n-drop data integration, transformation, and standardization solution, which offers huge reusability and drives automation with required collaboration, control, and scalability. It supports both ETL / ELT models for data transformation and aggregation.

Features
The key features of this solution include built-in metadata repository, Integration-as-a-service framework for third-party data sources integration, standardization tool, drag-n-drop data mapping, simple to complex data transformation management, import/export in multiple data types and format, and configurable data validation engine with library of OpenCDISC compliance checks; one-click Define.xml generator, change impact analyzer, data dependency analyzer, and version control; end-to-end data integration, transformation, and loading workflow automation with the ability to schedule the process and monitor, alerts & notifications, process manager, built-in intelligence for auto-mapping, role-based access controls, and collaborative workflows – all configurable & reusable.

Key Differentiators
A highly scalable, performance oriented, completely validated and 21 CFR Part 11 compliant solution; it provides a unique ability for non-technical or techno-functional users to take advantage of its end-to-end process flows for the most efficient way of standardizing clinical data for regulatory submission and/or transforming & aggregating data for analytics.

User Benefits
End users ability to bring in study data in the most effective and efficient manner with required traceability and manageability. Minimum to No programming needed; completely self-services.

Demonstrated 40% time and 50% cost savings

EXPERIENCE THE MAXISIT® DIFFERENCE

VOICE OF CUSTOMERS

“Having the highest quality clinical data and related information with efficient analytical tools available at all times is critical to managing our clinical programs and accelerating our innovation; and with MaxisIT’s Integrated Clinical Development Cloud, it was easy to achieve that across the portfolio of studies, and we were able to improve the quality of data and speed of decisions without increasing our support staff.”
Head of Clinical Projects
Multi-billion dollar pharma organization focused into rare disease
"Managing trials cost-effectively, and timely have been the biggest priorities in small biotech organizations with potential to grow; MaxisIT’s Integrated Platform just delivered that by allowing us to get faster access to data via clinical data repository, and role-based & self-service A&R platform to keep track of our clinical, operational, and administrative performance across the portfolio of oncology trials.”
Sr. Director, Project and Clinical Data Management
Oncology Biotech Company
“Implementation of MaxisIT’s clinical data repository enabled us easier, and faster access to our outsourced trials’ data in the most user-friendly manner, which improved our ability to respond to data quality issues, and conduct clinical data review in timely manner.”
Executive Director and Senior Physician Project Leader
Neurosciences Focused Business Subsidiary of one of the top 10 Pharmaceutical Companies
“Right combination of technology, process, and qualified people delivered via MaxisIT partnership enabled us to achieve above 50% reduction in protocol cycle time across the portfolio of trials, and also establish clear visibility across the trial performance.”
Head, Clinical Data Management
A Multi-billion Medical device company