Project & Clinical Data Management

Project & Clinical Data Management

Project Management
WCCT’s approach to study management is based on our patient-centric perspective.  Starting with the patient, then the site, then recruitment and ultimately the CRO services needed, WCCT is focused on what the study really needs: patients/subjects.  Each study is managed by a dedicated team to your study, avoiding the conflicted commitment that comes from shared resources.  We are also committed to team consistency – with nearly 100% staff retention.  CRO team experience averages 15+ years of related industry experience, across diverse therapeutic areas of expertise and are further supported by an executive team that is Physician lead. Prioritization and involvement From the top throughout the study duration.

Clinical Data Management  
WCCT offers cutting edge electronic data capture (EDC) solutions giving Sponsors options based on cost, timelines and clinical strategy.  We are flexible to implement our own clinical data management system, TrialMaster™ which offers a web-based interface allowing for quicker decision making, extensive reporting functionality and on-demand data export capabilities supporting the latest CDISC standards or utilize a Sponsor’s proprietary system; or collaborate with a preferred third party vendor.  Regardless of what system is used, WCCT’s focus is on the quality and integrity of the data collected.

In addition, our CPUs use TrialOne™ eSource platform which helps drive efficiency and reduces cost through faster volunteer recruitment, flexible screening questionnaires, direct data capture at our sites, work flow automation and modern data processing. The stream-lining of processes allows us to save time and money while increasing quality through enhanced user prompts leading to fewer mistakes and less data queries.

As a full service Clinical Data Management provider that leverages Best in Class Systems, People and Processes to provide a comprehensive, cost effective End to End solution. System independent, Our service offering includes:

  • Development of the Clinical Data Management Plan (DMP)
  • Database design
  • Preparation of the Data Validation Plan (Edit check specifications)
  • CRF/eCRF design
  • Database design
  • Data Entry of CRFs (paper system)
  • Data Review
  • Generate/track/reconcile data queries,
  • Provide coding dictionaries for AEs (MedDRA) and medications (WHO Drug) and perform data coding of all AEs and medications
  • Data reconciliation
  • Data transfer specifications
  • Interim analysis
  • Lock database
  • Transfer final datasets to biostatistician