Our software developers comply with 21 CFR Part 11 guidelines in developing specialized reports and applications. Our systems are compliant with FISMA and meet NIST moderate level security standards. We conduct our data management operations in accordance with GCP standards, incorporating global guidelines and regulations and FDA expectations and requirements. We can provide MedDRA and WHO drug coding and compatibility with CDISC standards.
Our data management staff are involved in all phases of a clinical trial from protocol concept sheet to final analysis. They contribute to the protocol document, develop procedure manuals, design and implement data collection instruments with extensive built-in QC, initialize registration and randomization and conduct training as needed. Depending on need, they will implement Frontier Science’s laboratory system and Web-based participant surveys. During study conduct they QA data systems, QC data, process data from specialized laboratories and other non-clinical sources, produce reports, perform final cleanup and assist in other preparations for interim and final analyses and close out study databases.
While clinical data are collected through cloud-based systems such as Medidata, individual projects often require a long-term database that may include several related trials or all of the studies conducted by a trials network. Frontier Science staff are very experienced in managing such databases, integrating data from various sources, incorporating them into structures that facilitate cross-study reporting and analyses. These databases are maintained in a facility that meets rigorous security standards and is replicated in real time to a disaster recovery site.