Data Management

Essential will provide comprehensive data management services for Phase I-IV clinical trials, emphasizing quality control throughout the process. A Data Management Plan specific to your trial will be developed with close sponsor communication. Our qualified team will develop your Case Report Form (CRF) and design the database, including sound data and programming edits to ensure data validity. The Data Management Team will also define data entry and review verification plans, query resolution process, central lab integration, medical coding specification, and data transfer formats. An experienced Lead Data Manager will integrate the Data Management Plan and Standard Operating Procedures to ensure a successful and timely database development, management, lock, and transfer.

Statistical Analysis

Essential will provide expert statistical and analytical support to help ensure comprehensive, reliable documentation of statistical analysis and reporting. Services include consulting during protocol design, definition of endpoints, statistical analysis methodologies, sample size determination, randomization plan, interim analysis reporting and final reporting of study results. All plans are designed to comply with ICH guidelines and incorporate sponsor comments and review. Our team is also available to present with you in meetings with the regulatory authorities.