The Symbio Biometrics Group works closely with our Clinical Group as part of an integrated project team to provide:
- Study design and protocol development input
- Statistical planning and analysis
- Database design
- Quality data review
- Complete clinical study reports
The Symbio Data Management team works in conjunction with the sponsor’s clinical staff to construct a master database that will contain all study data. The CRFs are reviewed in house and entered as they arrive. We never wait to accumulate large batches of study data, and this process enables us to identify commonly recurring errors up front. This reduces the number of study queries, which in turn reduces and controls project timelines.
Our medical writing team proactively contributes to protocol design, integrated study reports and integrated summaries on safety and efficacy. The medical writing team develops the shell reports containing the format of the report, tables, listings and all graphs. With our statisticians, the writers interpret the results and create integrated clinical/statistical reports that accurately present the study data in accordance with FDA and ICH guidelines.