Intelligent Data Management solutions that reduce complexity, improve quality, and reduce time to study Submission …. Provides an end to end solution (CRF design through DB lock).

When using clinCORE technology, database build is streamlined using the drag and drop interface. Users are able to create and utilize standard libraries and templates to further minimize start up timelines. In addition, CDSIC/CDASH standards can be incorporated into the study build, supporting STDM ready exports. This feature can reduce the cost of post database lock statistical SDTM conversion services.

Client preferred or proprietary technology can be utilized as well. The Data Management team has experience with the leading EDC technologies. In addition, the team is well versed in EDC systems in general and has a very quick ramp up time to match needed processes to the technology being used.

  • Improve Data Quality and Query Management
    • Guide site users through simple, accurate data entry
    • Prevent unnecessary data entry by disabling or hiding irrelevant fields
    • Drive cleaner data with real-time data validation
    • Reduce queries by saving forms as ‘incomplete’
    • Enable Clinical Research Associates and Data Managers to spend less time on query management, leaving more time for data analysis
  • Setup Electronic Data Capture Faster:
    • Streamline study build timelines with a simple to use, drag and drop user interface
    • Enforce standards across studies with reusable libraries and templates
    • Flexible support for the design of any phase and type of study
  • Reduce Complexity, Improve Quality and Reduce Time to Study Submission :
    • Establish corporate standards for CDISC, CDASH at study build
    • Standardize datasets across studies and therapeutic areas
    • Facilitate data exchange with multiple partners
    • Realize long term efficiencies
    • Ability to use standard tools and processes
    • Faster time and less costly creation of SDTM datasets, thus reducing the cost of statistical services

Data Management services include but are not limited to the following:

Electronic Case Report Forms (eCRFs)

The process of starting a new study begins with an in-depth review of the protocol to identify the necessary eCRF components (code lists, questions, groups, forms, and visits). The DM team can assist with the creation or augmentation of a standard CRF library if available. Utilizing standards facilitates the database build, maximizing efficiency during start-up. With the form objects now identified, the design process continues to the building phase. Upon completion the eCRFs are validated, with the team performing a walkthrough, where sponsors have an opportunity to review the CRFs in the EDC environment, and provide feedback.

Data Management Plan (DMP)

The DMP is the key Clinical Data Management document created for a study that references other documents used to setup, conduct and close each study. It includes the study workflow (i.e., data flow plan). The DMP is a living document and it will be prepared, maintained, and updated throughout the study.
Data Validation Specifications

The Data Validation Specification (DVS) document will list all the data validation checks (i.e., edit checks) to be performed on the study. The DVS will be prepared, maintained, and updated throughout the life of the study as needed.

Edit Check Programming

Using the final DVS document as an input source, developers implement edit checks into the database definition. Within our technology, edit checks encompass range checks on a single item, comparisons between items on the same form or different forms, as well as complex logic such as randomization algorithms. Edit checks are written in JavaScript, which is the standard programming language for adding interactive behavior to an HTML web page.

Edit Check User Acceptance Testing (UAT)

User Acceptance Testing (UAT) will be performed to test the ability of each edit checks to create true discrepancies and not to create false discrepancies according to the DVS. This will be performed by mock data entry of good data and bad data into test mode and reviewing the resulting discrepancies in the discrepancy database in test mode. UAT documentation for development testing and UAT will be reviewed and approved in order to deploy the database into the live environment.

Annotated CRFs

An annotated CRF is a copy of the CRFs with all the database field names annotated. The aCRF is provided to the sponsor for review and approval prior to the database being deployed into the live environment.

Conduct

Ongoing data review, supervision of data review and data cleaning planning are all services that can be provided.

Discrepancy and Query Management

Discrepancy management will be performed on all discrepancies generated from the edit checks programmed from the edit check specification document. Any self-evident corrections will be applied according to the agreements in the DMP.

Data Review

All eCRFs will be reviewed for any data quality issues which may not be detected from the automated edit checks. This data review will be performed using raw data listings. Anything identified from the data review will be sent to the site as a manual query.

Interim Deliverables

Standard project plan templates can be created to plan for and execute the tasks necessary to meet interim deliverables for DSMB, Safety Meetings, Annual updates etc.

Database Lock / Study Close Out

Standard project plan templates can be created to plan for and execute database lock and study close out. Prior to database lock, a pre-database lock data review meeting will be scheduled. The team will supervise or perform the lock and freeze of the data in the database after all parties agree that the data is ready to be locked. The criteria for locking the data will be specified in the DMP. It has been assumed that data will be cleaned for each cohort on an ongoing basis but may not undergo formal data lock until agreed upon.

Post Database Lock

After database lock, the team will supervise or complete the steps necessary to archive the data. Archive procedures will be limited by the functionality of the EDC system being used. The team will provide guidance or perform the creation of CDs containing each sites data to be retained with study documents at the participating sites.