Once all the data has been captured, ObvioHealth’s end to end capabilities store everything in a single system rather than the traditional multi-database solutions that require multiple vendors. We perform automatic data cleaning, auto-edit checks and advanced query resolutions as the data is entered, enabling us to more quickly advance to analytical review.
In the past, sponsors were not able to get access to their data until a formal interim analyses had been completed or at the end of the study. ObvioHealth data is readily accessible to sponsors on their own portal so that they have full visibility into the status of their studies throughout. We have built a standard set of analytics for display on the Sponsor dashboard, but we can also customize the data display to include additional items for sponsor viewing. The sponsor can also get direct access to the eTMF during and after the study.
Typical time for an ObvioHealth data lock is about 30 days. In some cases and because of our technology, we have been able to reach database lock in as little as 2 weeks.
ObvioHealth has in-house biostatisticians with specific therapeutic expertise and regulatory knowledge who provide high-quality deliverables for study design, statistical analysis, reporting and regulatory support. Our agile team is able to flex to ensure we match the needs of each study. We also work to deliver accurate findings as efficiently as possible. We are increasingly able to preformat some or all of our SAP output tables into the system and preprogram the biostat analyses. This can reduce the time needed to generate statistical tables by several weeks.
Our staff also includes medical writers with expertise in preparation of clinical study reports (both full version and abbreviated versions) as well as experience in preparing manuscripts and publications as per your needs