Study start-up is a pivotal phase in Clinical Data Management activities. Our team has experience creating hundreds of studies (Phases I, II, III, and IV). Key drivers during this period are Protocol finalization, SAP review, and eCRF design. This phase typically spans 4 months and requires significant efforts.
Our team will help you avoid costly errors and make the right decisions through this process. We communicate tasks and timeline status proactively. We understand that acceleration to go-live is often required and we can work with you on the best way to achieve your goals.
Study Conduct brings challenges that our qualified team can help you solve. We help you make the right decisions by providing you critical study quality metrics.
Other CROs will often lose focus during this period of routine activity and fall weeks behind with data quality and queries. We are metric/quality driven and understand the importance of keeping the clinical study database current.
Study Close Out
Study close out is where you reap the benefits of experience. With BPG managing your start-up and conduct, study close out will be efficient and fast!
Our CDM team will help you focus on the key variables that directly drive safety and efficacy analysis. We have closed hundreds of databases and our experience means you get the quality data outputs you need.
- Protocol and Protocol Amendment Review
- Creation of Core Documents (Data Management Plan, Data Quality Plan, Communication Plan, Study Timelines, eCRF Guidelines, etc.)
- Global Library Development or Integration
- eCRF Development
- Edit Check / Logic Check Creation
- IWRS/IVRS Set-up
- User Acceptance Testing (EDC system)
- External Vendor Set-up (Central / Local Labs, Imaging, ECG, etc.)
- SAE Reconciliation Plan
Study Conduct Services
- Query Management and Data Review
- Medical Data Review
- Data Listing Creation and Review
- Study Metric Reports (Outstanding Queries, Missing Pages, Expected Pages, etc.)
- SAE Reconciliation
- CDM Project Management
- Mid-study Database Changes
- Data Tranfers
- Interim Analysis Cleaning and Data Transfer
Study Close Out Services
- Database Soft-Lock Activities
- Critical Variable Cleaning
- Final Database Lock Activities
- Database Un-lock and Re-lock Activities (should be rare!)
- Database and Study Record Archival