Clinical Data Management for Biotechnology, Pharmaceutical, and Medical Device Companies

Our Expertise

  • Our clinical data management 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 the 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 Approach

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, if applicable

  • 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 Solutions

Clinical Data Management

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 the 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 only some people are experts in data management. Therefore, we can guide you along the way.

Clinical Data Management

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.

Clinical Data Management

A Proactive Approach to Data Management

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

Clinical Data Management

Our clinical data managers work smart.

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 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.

Contact us 24/7 for a free consultation 

Call us now at (669) 900-1414!