Clinical Data Management

Clinical Data Management You Can Count On

At Celerion, we provide full clinical data management services—from the creation of data collection forms and standards through provision of high-quality, submission-ready data that meets industry standards. As a member of CDISC we not only ensure standards are followed, but we apply our experience and expertise to help further develop and refine data standards in the future. Our focus is to deliver high-quality, accurate data, while maintaining rapid timelines.

Our team has managed an extensive number of clinical pharmacology studies focused on many special populations including but not limited to oncology, hepatic-impaired, renal-impaired and cardiac-impaired patients.

We set initial expectations, fully scope the program, and standardize accepted data formats, saving you time on the back-end. By using our submission database content/structure throughout your drug’s development lifecycle, we reduce costs and eliminate rework.

Our team has experience and expertise in early clinical research and development, overseeing all clinical trial data management for your study from beginning to end. We work with internal and external sites and monitors to review, trend, query and clean data on an ongoing basis. Our robust processes, SOPs and technology allow us to deliver ongoing feedback on entry and monitoring. As a result, we provide transparency so you can make data-driven decisions to move your clinical program forward.

Our clinical data sciences team offers flexibility through ClinQuick®, our proprietary electronic data acquisition system. Additionally, we utilize OmniComm TrialMaster® as the preferred electronic data capture system, ensuring accurate, high-quality data and reducing time to database lock for multi-site studies.

Our all-inclusive data reporting saves you time and money on overall drug development timelines. To maintain compliance with the FDA and other regulatory agencies, we expedite the delivery of clinical study data into SDTM and ADaM format. As part of our comprehensive offering to fully support your team we can also provide extensive biostatistics services, such as detailed statistical analysis plans; tables, figures and listings (TFLs); and PK/PD analysis and interpretation. Lastly, we can deliver your ICH E3 Clinical Study Report as a fully electronic PDF, in a format that will assist you in the publishing and submission process.