Advanced SAS Programming *** Efficient Data Management
Advanced SAS Programming *** Efficient Data Management

KCT Data, Inc. Capabilities

 

KCT Data focuses on efficiency and simplicity in order to meet the client’s needs.  KCT Data provides data management, DM Project Management, SAS programming and data integration for all size studies.  KCT Data provides each client with specialized services that ensure client satisfaction.

 

KCT Data, Inc. offers the following Services.

  1. Data Management Department Support:
    1. Clinical Data Management oversight/management for clients using larger CROs
    2. Implementation of CDASH CRF standards
    3. Development of Standard CRFs, with associated CCGs, db structure and validation checks
    4. Clinical data management and development process redesign
    5. Development of SOPs
  2. Data Entry Study Start-up:
    1. CRFs: CRF design; CCG development; printing arrangements
    2. CRF completion training at investigator meetings
    3. Paper and EDC Solutions
    4. Database design and data entry system setup
    5. Annotated CRF preparation
    6. Validation Plans: writing and programming
  3. Data Entry Study Execution:
    1. Data Entry: Double key with reconcile using a SAS based system, which is 21CFR Part11 compliant.
    2. Data Review, including electronic audits and manual review as needed
    3. Queries: writing/preparing, distribution and communication with site for resolution
    4. Reports: Forms received, entered, verified, query tracking reports, client defined and standard
    5. Standardized Coding: MedDRA (MSSO trained), Costart, and WHO-DD.  Also experience with developing classification systems for medications (for example, if WHO-DD is too complicated for your needs)
    6. Integration of External Databases (such as labs or reading center data) with CRF data, including validation against CRF data
    7. Classification and organization of external photographs or digital images or other digital media files
  4. Data Entry Study Close-out:
    1. QA of data entry and any queries applied
    2. All documentation and memos for compliance and quality assurance drafted
    3. CD (or DVD) of final locked dataset for Master File archiving, if desired
  5. SAS Support and Database Programming:
    1. Preparation and quality review of CDISC format datasets (such as SDTM, ADAM, SEND) and associated documentation
    2. Database standardization and integration across studies for data warehousing
    3. Preparation of Integrated database for Summary Reviews
    4. SAS mentoring for junior or novice programmers
  6. Statistical Department Support:
    1. Data listing and data table design
    2. Advanced SAS programming support: Certified SAS Base Programmer, Base, Macro, SQL, ODS, AF/Frame and SCL, FSP
    3. ISS experience: planning, table programming, and writing
    4. Data listings and table programming
    5. Quality control audits of databases, tables and listings

 

KCT Data, Inc. partners with several companies to offer the following addition services.

  1. QA / GCP Support
  2. Clinical Study Start-up, Project Management, and Monitoring
  3. EDC capabilities
  4. Advanced statistical and medical writing support
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