Clinical Data Management 


Our Expertise

  • Our clinical data management team can support all data capture and analysis aspects. In addition, we can ensure the efficient collection and delivery of the highest-quality data.

  • We have expertise in various software solutions. In addition, AMSTAT Consulting partners with multiple data management platforms.

  • Our clinical data managers provide the best possible solution for your clinical trial. Thus, we are a one-stop shop for data management activities.


Explore our clinical data management services

  • Consulting (e.g., strategic program planning, protocol review, EDC selection)

  • Case report form (CRF) design utilizing the most up-to-date SDTM implementation guides

  • Database design, development, and maintenance

  • Data validation programming and testing, inclusive of edit check and manual review specifications

  • Data entry

  • Data cleaning and query management

  • Medical coding using WHODrug & MedDRA dictionaries

  • 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

  • Database transfer


Clinical Data Management

Our Consultative Approach

  • Our clinical data management team can provide a consultative approach to data management activities. For example, we understand your goals and provide feedback. In addition, we have flexibility in our processes.

  • Our clinical data managers can determine the right EDC solution for you. In addition, we can plan for each phase.

  • Our clinical data management team can help you understand the elements of data management and guide you through key interim and deliverables to completion.

Clinical Data Management

Data Managers

Our data managers are certified in at least one EDC system. They know database build considerations and can support your data management needs.

Clinical Data Management

A Proactive Approach to Data Management

Our processes support a proactive approach to each element of data management. We build CRFs as SDTM-compliant. We also perform data cleaning to maximize query success rates. In addition, our experts perform database lock on a rolling basis.

Clinical Data Management

Database Design

We design databases with the end-users in mind. For example, we use dynamic search tools to publish expected fields based on previous entries. Similarly, we develop data management documents like the CRF completion guidelines.

Our clinical data management team can think proactively about our downstream stakeholders. Our biostatisticians play an active role in initial CRF development and mid-study changes.

How can we help you? Please get in touch with us 24/7 for a free consultation.

Please call us at (650) 460-7431 or email us at: