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Statistical Analyses

Proactive involvement of our biostatisticians and clinical data coordinators helps to assure the efficient and accurate collection, analysis, and interpretation of clinical study data. Our biostatisticians are an integral part of the strategic planning process as they are involved in prospectively defining study objectives and selecting the most appropriate study design, research subjects, sample sizes, clinical endpoints, and statistical analyses. Our biostatisticians and clinical data coordinators assure that data are collected accurately and completely through their involvement in the study protocol and case report form design, review, and approval process.

ABR data management personnel utilize Oracle Clinical™ as a state of-the-art, validated data management system and pay close attention to complying with 21 CFR Part 11 Electronic Records regulations. Our personnel also have experience with Clintrial™ and etrials QuickStudy Capture™. Data collection can be accomplished using paper data capture (PDC) via conventional case report forms or electronic data capture (EDC) via remote data entry. Our clinical data coordinators and database programmers work in conjunction with the project team to design a database and user-friendly data entry screens to meet the sponsor's and ABR's rigorous specifications.

In addition to a thorough, in-house case report form review prior to data entry, customized edit checks are built into the database which provide real time checks throughout the data entry process as well as rigorous batch mode or ad hoc edit and validation checks. Independent double-key data entry is performed and a complete audit trail is maintained for all data entries, corrections, and clarifications and all data query reports and resolutions. Key efficacy and safety variables are identified and verified against the case report forms. Our data management team prepares customized data listings, and our SAS programmers and biostatisticians work closely with the project team and sponsor to execute the statistical analysis plan.

Our Data Management team, working in conjunction with our Medical staff, have extensive experience in adverse event, medical history and medication coding, using MedDRA and WHO-DRUG or other client-specific dictionaries.