A Typical Frontier Science Project
Each project is different – but here are some of the responsibilities that Frontier Science undertakes in many projects, presented within the context of the lifecycle of a typical clinical trial:
Study Development and Startup
Frontier Science biostatisticians and protocol specialists collaborate on protocol design, prepare study materials and ensure that all components are in place to begin trials. Our technical staff configures EDC and CTDMS systems. They provide Frontier Science’s registration/randomization and laboratory data (LDMS) systems as needed. If requested, they will also provide custom software, reports, and a project website. Education staff then train project members so that researchers can hit the ground running.
While a study is in process we conduct daily QA and QC on study systems and acquired data, process specialized data transmissions and provide support to study sites and laboratories. We provide training in data management and software and conduct ongoing monitoring visits to ensure protocol adherence and site compliance. We also perform database retrievals, report generation, and input of AER reviews and determinations into the database. At specified points in a trial we prepare interim analyses and report to DSMBs and IDMCs.
As a study approaches completion our team conducts final site visits, data acquisition and data cleanup. Biostatisticians consult with the study team in preparing analyses and reports. The study database is archived from the CTDMS system. A copy of the database is handed over to the sponsor, along with a summary report on the study, data accrual, and activities of Frontier Science staff on behalf of the project.
Frontier Science provides expertise in developing and maintaining Standard Operating Procedures (SOPs) that fulfill current US federal and international requirements for maintaining confidentiality and complying with HIPAA and quality assurance regulations for clinical trial conduct.