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A cloud-based, configurable and homogenous computing platform, Clinical Data Repository (CDR) leverages existing investments by integrating, exchanging and analyzing Health Care data as per industry business needs. It improves accessibility of data in the desired format, empowering end users to effectively utilize data assets. Additionally, CDR serves the industry as a One Stop solution for Data Integration, Aggregation, and Standardization.

ADVANTAGES

  • One stop solution for data, metadata, reporting and analytics serving the needs of disparate business and IT users.
  • Improves accessibility of data in the desired format.
  • Empowers end users to effectively utilize data assets with built-in, self-service capabilities for data reviews and for performing various advance prognostic analysis.
  • Improves efficiency and quality management.

KEY FEATURES

MaxisIT’s Cloud-based Clinical Data Repository (CDR) contains the following primary features:

  • Data Transformation & Standardization: Built-in data transformation & standardization processes and completely metadata-driven and automated approach.
  • Data Validation & Quality Management: Built-in library of standard validation checks and support for building custom validation checks in non-programmatic fashion.
  • Data type & Size Support: Supports the storage different types of high volume data across all formats, sizes and types.
  • Instream Metadata Repository: Stores CDISC, HL7 standard models, Clinical metadata, Operational metadata, and Healthcare Metadata, along with the Semantic Search capability.
  • Manageability: Built-in version & change controls, snapshot management, organization structure management, data model management, backup & archive management, role-based access management, and data provisioning management.
  • Audit trail and Traceability: Each asset and activity addresses the paradigm of who is accessing the system, along with knowledge of what got modified.
  • Slicing & Dicing of Data: The ability to create data snapshots & data marts to address specific data access needs across individual departments and stakeholders.
  • Controlled Data View: Viewing the data in blinded or unblinded or de-identified mode as per assigned roles and access privileges.
  • Integration as a Service: A set of Application Programming Interfaces (APIs) to link / access / extract data from multiple external third-party systems.
  • Analytics: A preconfigured set of out-of-the-box reports and visualizations supporting various descriptive and data-driven analytics.
  • Statistical Analysis: Integrated statistical analysis, environment to conduct sophisticated trending and “what-if” analysis.
  • Regulatory Compliance: 21 CFR Part 11 compliant and validated.

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CUSTOMER SPEAK

“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

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