Clinical Research Organization

Clinical Data Management

Database Development

• Create database specifications:

  • Global EDC Settings

  • Live Database User Roles

  • Time and Events Schedule

  • Study Forms

  • Edit Checks

• eCRF development

• Edit check development & programming

• Perform study database testing including creation of a UAT Testing Plan and Final UAT Report

• Database build management and oversight

Data Management

• Create and maintain the Data Management Plan (DMP) including specification of Manual Data Review Listings

• Create eCRF Completion Guidelines (eCCGs)

• Provide training for sites, Sponsor, and the clinical team as it pertains to the database and eCRF Completion

• Perform data review/cleaning and query generation and resolution

• Perform database access administration

• Perform dictionary coding

• Perform SAE reconciliation

• Perform external data reconciliation of PK and PD data including creation of Data Transfer Agreements

• Perform formal data review cycles

• Liaise with Sponsor and any designees

• Maintain Data Management study timelines and study related documentation

• DM Project Management tasks such as meeting facilitation and attendance, metrics reporting, correspondence with Sponsor and Third Parties.

• Perform database closeout and provide final documentation

Data Programming

• Manual Data Review Listing development

• Routine project status updates (frequency to be mutually agreed)

Statistical Analysis Plan

SAP development includes individual studies as well as ISS/ISE.

• Develop SAP

• Prepare TFL Shells

• Update SAP and Shells

• Sign off SAP and Shells

SDTM

SDTM services includes CDISC compliant studies and legacy studies in submission format.

• aCRF SDTM annotation

• SDTM specifications

• SDTM mapping

• Independently validate SDTM domains

• Pinnacle 21 validation

• Create Define.xml

• Create Study Data Reviewers Guide (SDRG)

• Convert SDTM domains to transport file

• SDTM transfer/Dry run and final SDTM transfers

ADaM

ADaM production applies to individual studies as well as ISS/ISE.

• ADAM specifications

• Create ADaM datasets

• Independently validate ADaM datasets

• Pinnacle 21 validation

• Create Define.xml

• Create Analysis Data Reviewers Guide (ADRG)

• Convert ADaM datasets to transport files

• ADaM transfer/Dry run and final ADaM transfers

Tables, Listings, Figures (TFLs)

TFL production applies to individual studies and ISS/ISE.

• Create TFLs for CSR according to SAP and shells

• Independently validate TFLs

• Data quality review, data reconciliation and consistence checking

• Dry runs and final transfer of TFLs