Data Management
 
Qualtran’s approach is to provide our clients with clinical data management solutions that are customizable to client requirements, cost-effective, secure, regulatory–compliant, and expedite the data collection process, regardless of the data collection method our clients choose. Our systems, SOPs, and personnel are equipped to manage all 3 methods of data capture:

  • Paper
  • Fax
  • EDC - Web-based data capture

    Supported by our leading-edge data management systems and integrated SOPs, our CDM staff can fulfill unique project requirements, such as:

  • Quick database set-up
  • Sponsor-defined CRF and DCF management rules
  • Customized query wording for clarity and conciseness
  • Accelerated query management
  • Unscheduled data reviews
  • Study timeline changes
  • Changes to Protocol, CRF Template and project specifications

    Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines.

    The following is a summary of our data management services and procedures:

  • Data Management Plan -
    Project-specific data management standards and SOPs

  • Database Design -
    - Database definition
    - Database security
    - Data entry screens

  • Data Validation Plan
    - Initial programming and query wording
    - Testing and locking data validation plan
    - Periodic re-testing

  • Data Entry (paper)
    - Ongoing data entry from CRFs – single or double entry
    - Data entry cleaning

  • Medical/Science Review
    - Review of marginal notes on CRFs and Data Alerts
    - Evaluating medical and scientific consistency of data

  • SAE Reconciliation
    - Reconciliation based on central SAE database vs. study database

  • Medical Coding
    - Coding of adverse events (MedDRA, WHO-ART, COSTART)
    - Coding of concomitant drugs (WHODRUG)

  • Data Validation and Query Management
    - Periodic validation of CRF data - Flexible query routing
    - Accommodating 3rd party queries - Query and resolution management over the Internet

  • Central Lab Database Imports
    - Incorporating 3rd party databases

  • Database Lock and Audit
    - Interim and final database locks with associated documentation

  • Database Documentation & Release
    - Database transfer in Sponsor defined formats (ASCII, SAS, and XML, as per CDISC specifications) with detailed documentation

    To ensure the integrity and accuracy of the study data our Project and Data Managers follow corporate QC and QA processes. Our QC process involves periodic review of: 1) CRF and DCF tracking and filing; 2) data entry errors and data management procedures; and 3) Data entry vs. original paper CRFs. Further, we QC the scientific integrity of the database by ensuring the consistency between the Protocol, SAS database and CRF Template. Our QA process formally assesses compliance with corporate and study-specific SOPs.

    ELECTRONIC DATA CAPTURE (EDC)

    Our secure and 21 CFR Part 11-compliant edc system with its intuitive user interface is used to host your studies on-line.

    Key benefits include rapid deployment, flexible study configuration for all phases of trials, comprehensive on-line data validation, rapid change management, and experienced user support. Our system and services ensure analysis-ready data at any time.

    Our experienced group of Project Managers, Database Managers, Database Coordinators, Data Reviewers and System Administrators direct and maintain the entire EDC process for our clients. Their responsibilities include:


  • Study set up
    - Specify project parameters and project team
    - Issue user certificates
    - Define access privileges

  • Design user-friendly data entry screens
  • Implement on-line data validation
  • Produce/customize status reports and data listings
  • Trial protocol and on-line help
  • Database exports and locks
  • User support


    All project related personnel (Investigators, Coordinators, Monitors, CRAs, Data Reviewers, and Sponsors etc.) can easily navigate through all study data (CRFs and DCFs) and status reports with a standardized user-friendly interface. A customizable and robust workflow, combined with our data management SOPs seamlessly integrate all of the data management steps.

    Our IT department will maintain and host the system, and manage a fully operational support desk. To ensure the highest level of security and maintain the functionality of EDC, we have designed our multi-layered network with multiple firewalls to mirror those of the banking industry. Our architecture ensures that only fully authenticated users are able to access our internal LAN. Our security protocols begin with controlled access to the premises, workstations and servers; followed by controlled access to the databases and systems over the Internet, intrusion detection, virus scanning at all ports of entry and concludes at document-level access control. Our EDC solution incorporates electronic signatures protected by digital signatures with all electronic documents transferred over the Internet using SSL 128 bit-encryption.

    BIOSTATISTICS

    Qualtran has a dedicated biostatistics department. Our staff has experience in the design and analysis of clinical trials ranging from parallel group, cross-over and Bayesian designs to complex (population) pharmacokinetic- and dynamic evaluations, therapeutic equivalence testing and large variable sample size sequential designs.

    Our biostatistical services can be customized to your individual needs ranging from SAS programming as per your analysis plan, to in-depth biostatistical support of your registration trials. For registration trials, we can develop optimal designs according to therapeutic area–specific regulatory guidelines; provide client representation at IND meetings in support of the designs and analysis plans and develop full SAPs resulting in a complete “submission-ready” clinical research report with supporting documentation.

    Our biostatistics services include the following:

  • Study design
  • Analysis and reporting of pre-clinical and Phase I-IV clinical trialsof various designs to match the objectives of the study
  • Randomization – envelops, fax or web
  • Periodic data monitoring and safety reviews (DSMB)
  • Unscheduled interim analyses
  • Post-hoc and exploratory analyses
  • Formal interim and final analyses
  • Statistical consulting.

    Qualtran Biostatisticians and SAS Programmers follow corporate SOPs to ensure the consistency and integrity of study results. We have a multi-stage procedural and scientific QC process. Our procedural QC process involves periodic review of programming standards (program structure, notation, unit testing and electronic filing of programs). Our scientific QC process involves reviewing the scientific integrity of the analyses by the Project Director (to ensure the consistency of the Protocol vs. SAS databases vs. SAP vs. statistical results). Upon project closure, our QA process assesses compliance with corporate and study specific SOPs.

    Supported by our IT systems and integrated SOPs, our Biostatisticians are able to accommodate:

    Client defined analysis standards

  • 3rd party databases
  • Programming support for varying reporting formats and standards
  • Changes to Protocol, CRF template and project specifications
  • Timely response to ad-hoc requests
  • Collaboration with 3rd parties for report and manuscript writing

    Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines.

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