Clinical Data Management for Biotechnology, Pharmaceutical, and Medical Device Companies
- Our team members are on-hand to advise and support all aspects of data capture and analysis. Thus, we have extensive experience in all phases of trials. In addition, our team members ensure efficient collection and delivery of the highest quality data.
- We have knowledge and expertise across a wide range of software solutions. In addition, AMSTAT Consulting partners with various data management platforms to support your individual needs.
- Our clinical data managers provide you with the optimal solution for your clinical trial quickly and efficiently without compromising data quality. Thus, we are a one-stop shop for all data management activities from database build to database lock and archival.
- Our team members are focused on developing partnerships routed in quality, efficiency, and transparency. Thus, the result: cost-efficient data management; faster time to database go-live; a functioning, intuitive clinical database; expedited database lock; and accurate and clean clinical trial data.
EXPLORE OUR CLINICAL DATA MANAGEMENT SERVICES
- Cross-functional biometrics team plans
- EDC, including accredited Medidata Rave support
- Risk-based monitoring
- CDASH standard datasets
- Consulting (strategic program planning, protocol review, EDC selection, etc.)
- Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
- Database design, development, and maintenance
- Medical coding using WHODrug & MedDRA dictionaries
- Data validation programming and testing, inclusive of edit check and manual review specifications
- Data cleaning and query management
- Serious adverse event (SAE) reconciliation
- Management and integration of local laboratory reference ranges with CRF data
- Integration, verification, and reconciliation of external electronic data
- EDC selection and end-user training
- Database lock and archival
- Extensive edit checking
- Database transfer
- Site metrics for CRF completion and Query Resolution
- Continual Quality Control review including audit trail logging
- MedDRA and WHODrug coding
- AMP, cell therapy studies, Observational, Device, and Marketing studies
- 3rd party vendor oversight and data transfer planning
FLEXIBLE AND CUSTOMIZED DATA MANAGEMENT SOLUTIONS
Our Consultative Approach
Our clinical data managers take a consultative approach to all data management activities. For example, we understand your ultimate goals and provide feedback. In addition, we have flexibility in our processes.
- Our clinical data managers can determine the right EDC solution for you. Additionally, we can balance short-term goals against long-term vision for your programs. In addition, we can plan proactively for each phase.
- Our clinical data managers can drive key interim and final deliverables to completion. In addition, we can help you understand the critical elements of data management and how each item impacts other stakeholders.
- Our biostatisticians realize not everybody is an expert in data management. Therefore, we can guide you along the way.
All Data Managers are EDC-Certified Designers
All our data managers are certified designers in at least one EDC system. Thus, we are knowledgeable about all database build considerations. Therefore, we can support your data management needs.
A Proactive Approach to Data Management
Our processes support a proactive approach to each element of data management. Case Report Forms are built as SDTM compliant as possible from the start. Data cleaning is performed to maximize query success rates. Database lock is performed on a rolling basis.
Our clinical data managers work smart. Databases are designed with the end-users in mind.
- For example, we use dynamic search tools to publish fields that are expected based on previous entries.
- Similarly, we focus on developing data management documents like the CRF Completion Guidelines to provide thoughtful information to sites.
- Our clinical data managers think proactively about our downstream stakeholders. Our biostatisticians play an active role in initial CRF development and any mid-study changes.