Kinship Technologies

Products

EXACT Product Overview

EXACT – is a comprehensive and flexible product that enables the user to extract, view, transform, analyze and report data in a standardized format across clinical applications, projects or trials. EXACT seamlessly integrates both clinical and non-clinical data from multiple sources and across different stages of clinical development, in a regulatory compliant manner for rapid analysis and reporting.

This is achieved in EXACT by extracting data from various sources for a study and creating a fully controlled, traceable, regulatory compliant data model for use in various modules within the product.

The team at Kinship has designed a metadata repository based on CDISC models using the vast amount of data that is accumulated during the clinical research lifecycle. Using this metadata repository, many of the steps between the capture of clinical data and the generation of an eCTD submission can be automated, with great savings of time and resources.

EXACT has pre-configured auto-mapping features, which provide for multiple statistical options that can be matched to the statistical analysis plan for the execution of the required analyses on the trial data.

Input Sources EDC: DataLabs Medidata Oracle Clinical Other EDC systems File Types: ASCII Text ODM XML CSV XLS SAS: XPT SAS Dataset Dictionaries: MedDRA WHODrug Output Formats Clinical Data Standards: CDISC SDTM 3.1.1/3.1.2 ADaM 2.0 SEND 2.3 User Defined Reports Regulatory Agency Submissions: Define.XML CSR Generation WebSDM (JANUS) Validation eCTD M5 Validation Reports Biostatistics and Analytics Reports: Mockup Generation Tables, Figures and Listings Randomization Subject Profiles Code Generation User Defined Reports Regulatory Standards Compliance: GCP ICH E3, E6, E9 Standards GAMP Category 4 GPP 21 CFR Part 11 Compliance

EXACT Modules

EXACT is organized into four major modules:

• Data Extraction, Integrity Checking & Loading
• Clinical Data Standards Implementation & Mapping
• Biostatistical Analysis
• eCTD Module 5 Generation

These modules are designed to function in both an integrated manner as well as independently, based on the organizational needs and licensing requirements.

The product integrates audit trails, user stamps and versioning into the data, in order to ensure compliance with regulatory requirements, including 21 CFR Part 11 and Good Clinical Practices (GCP). A human readable audit trail report is available for each study, detailing where the data came from, the transformations performed and the structure of the resulting analysis data sets. This approach allows a high level of transparency and clarity regarding data content and integrity.

EXACT provides a single repository for all clinical and non-clinical data contained in a submission. Data can be accessed in accordance with any hierarchy, such as analysis, study, project, therapeutic area and company. Each level in study hierarchy has a set of configurable features which is editable at the lower level allowing users to maintain individual configuration sets at analysis level as well as at company level.

EXACT Key Features

The EXACT system is an integrated development environment that can create reusable programs for data extraction, data transformation, statistical reporting, and electronic publishing. The system provides a framework that simplifies and automates the following activities:

• Extraction of data from clinical data systems, including popular EDC systems and CDISC ODM-compliant sources;
• Transformation of "raw" clinical datasets into standard CDISC-compliant datasets, such as the Standard Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM); validation of these datasets using regulatory standards;
• Integration of clinical data with coded data from medical dictionaries/thesauruses;
• Generation of specification documentation required by regulatory authorities (eg, DEFINE.XML);
• Creation of standards for tables, figures, and listings (TFL) shells used for statistical analysis and reporting;
• Development of programs that generate TFLs based on defined TFL shells; and,
• Preparation of electronic Common Technical Documents (eCTD) for the purposes of electronic submissions to regulatory authorities.

The value of EXACT rests with its potential to significantly automate key processes that involve high-cost database and analysis programming resources. Through a "menu-driven" graphical user interface, the EXACT system allows users to quickly "construct" SAS programs by re-using pre-fabricated, but configurable, standards.

EXACT Key Benefits over Manual Programming

• Global Library
  
  The Global Library function manages the following items for re-use:
  • Set of mockups/shells for tables, listings, and figures
  • Library of statistical configurations
  • Global formats library which can be used for CDISC standards and biometrics implementation
  • Static and reserved domains and elements available as per CDISC standards
  • Library of derivation templates in different categories
• Adherence to CDISC Standards
  EXACT's clinical metadata model for its biostatistical analysis & reporting facilitates rapid CDISC conversion. The metadata model uses CDISC standards as its base, and permits users to manage the metadata to accommodate legacy and other proprietary standards. The tool also performs checks to ensure CDISC compliance
• Job Scheduling
  EXACT features a Job Scheduler which allows for re-execution of programs and extractions at a user defined frequency
  
• Auto-mapping
  EXACT automatically maps ODM compliant clinical trial source data to CDSIC SDTM, as well as from SDTM to ADaM.
  
• Quality & Consistency
  Validated, 21 CFR Part 11 compliant environment provided by EXACT eliminates the need for manual user validation. Automated CDISC conversion with auto map feature results in zero validation effort while ensuring quality and consistency.
• Consolidated View of Clinical Data
  EXACT provides a single repository for all clinical and non-clinical data generated by a study using the Clinical Integrated Data Repository. This allows the clinical team to quickly assess items such as study progress and safety, as well as create and manage analyses datasets after repeated amendments to protocols and the SAP. It also facilitates a much quicker creation of the appendices binder for clinical study report (CSR) preparation following the recommendations of ICH E3.
• Complete Traceability
  EXACT offers a complete traceability from extraction to submission using version control, an audit trail, and security profiles, as well as system-generated compliance reports.
• Reduce Risk & Cost of Ownership
  EXACT facilitates a consolidation of trial data for a single study as well as across multiple studies in a single, controlled environment. EXACT can also reduce the overall cost of IT systems ownership by creating a single analytical, integration and reporting system for activities such as metadata management, blinding and un-blinding, data visualization, as well as report execution, storage and retrieval, all within the application’s workflows and across the entire clinical development organization.
• Automated Complex Process & Approval Chains
  Automated workflows can be configured to automatically route information to anyone who needs to review or approve it.