Clinical Trial Data Management

Clinical Trial Data Management

Efficient Clinical Study Data Management

GBC works with clients to develop clinical study data management plans and clinical trial databases.  GBC offers efficient and compliant services for database development, database validation, data capture, data cleaning and adjudication, database lock and reporting.  GBC complies with 21 CFR Part 11 compliant processes for electronic clinical data management (eCDM) and the use of electronic Case Report Forms (eCRFs).  GBC data management services cover:

Clinical Trial Data Management Services

  • Development of Trial Data Management Plan
  • Electronic Data Capture (EDC) Platforms (including various cloud-based EDC platforms)
  • Remote Data Entry (RDE) and Remote Data Capture (RDC)
  • Development of Study Data Elements and Data Dictionaries
  • Data Coding Schemas
  • Design of electronic Case Report Forms (ECRFs), Case Report Forms (CRFs), and CRF Books
  • Production, Distribution, and Collection of Case Report Forms (CRFs)
  • Case Report Form (eCRF/CRF) Completion Guidelines (CRFCGs)
  • Data Consistency/Discrepancy Rules and Error Checks
  • Data Query and Discrepancy Resolution Processes
  • Study Reports, Progress Metrics, and Projections
  • Data Blinding and Un-Blinding Requirements

Database Development

GBC offers database development and data management services utilizing a variety of database platforms based on specific study needs, including:

REDCap Cloud is a robust 4th generation EDC solution with transformational built in features including Mobile App Based EDC, Mid-Study Changes, Monitoring, Query Management, Medical Coding, Custom Randomization, and a File Repository. All protected by industry best practice security,21 CFR Part 11 compliant, industry regulations and data privacy technology.  For more information  please visit www.redcapcloud.com.

Castor offers tools for electronic data capture (EDC), electronic consent (eConsent), and patient reported outcomes (ePRO) that are fully 21 CFR Part 11 compliant to meet regulatory, marketing and product development needs. Castor manages single center or multicenter trials (including decentralized trials) with a user-friendly interface and advanced user management and workflow capabilities that streamline your data capture requirements. Castor ranks amongst the top 5% EDCs for shortest build times, with over 90% of studies being deployed within 4 weeks.  For more information  please visit www.castoredc.com.

Medrio supports an integrated eClinical software platform with a fully hosted EDC system. Their cloud-hosted technology features an easy drag-and-drop interface, allowing study managers to build their studies in days instead of months without requiring any programming. Medrio’s new mobile suite of eSource products supports both event-based and subject-based workflows, offline data entry, and Patient Reported Outcomes. Though Medrio has extensive experience in all study phases, their software leads the way in early-phase and Phase I trials, with over 500 Phase I trials to date. For more information  please visit www.medrio.com.

GBC database development services cover:

  • Database Functional Specifications
  • Database Design (Forms and Reports)
  • Database Validation (Validation Plans and Test Data Sets)
  • Database User Acceptance Testing (UAT)
  • Database Operator Training
  • Database User Access Management and Tracking
  • Database Audit Trails and Change Histories
  • Database Support

GBC clinical trial data management services also include:

  • Clinical Data Entry
  • Data Quality Control Review
  • Data Adjudication
  • Database Lock
  • Data Reporting
  • Data Archiving

For additional information on GBC’s clinical trial services please contact trials@globalbioclinical.com or register and send us your inquiry here.