Trial Oversight with OctOver
OctOver for Phase I–III studies
What is happening in your study, at a glance
OctOver is our oversight tool on the Octovis platform. It turns your study data into interactive views and reports for sponsors: study status, site performance, queries, participant profiles and safety monitoring, all with filters. We configure it fully to your study and your questions. At the end of the project, you receive the complete app with your data and all reports, yours to keep. On request, our experts run the oversight for you in Data Management, Programming, Biostatistics and SOP management.
When studies are outsourced, the challenge is keeping control. With OctOver you look at the data yourself: how sites are performing, which queries are open, missing or closed, and where attention is needed. Filter by arm, sex, age or country, without waiting for the next report.
Start early at protocol and setup to avoid rework, or step in midstream to stabilize a running study.
How it works
OctOver adapts to your study status, and so does our expert support. Start where you are and move forward with control.
Entry Point A (Early):
Start at protocol and EDC setup: align early, avoid rework.
Entry Point B (Rapid):
Step in fast: stabilize execution, control risks, get back on track.
We can join early to shape protocol/setup, or enter rapidly midstream to stabilize delivery. In both cases, we align stakeholders, validate readiness, and drive actions through clear oversight reporting.
The Octovis platform
Oversight works best when the information behind it is structured and connected. Octovis is our platform for exactly that: modular tools that bring study information together, connected through one central hub.
OctOver: the oversight view
Study status and site performance, queries by status, and participant profiles with medical history, exposure, adverse events, concomitant medication, vital signs, ECG and labs. Safety monitoring with AE incidence by SOC and PT and AEs by treatment arm. All views and reports are interactive and can be filtered, and profile reports are generated on demand.
OctoHub: one entry point
Central access and administration for all Octovis modules. Each organization has a key user who manages access, while study work and content stay in the modules themselves.
Expert review: SDTM & ADaM
On request, we review your SDTM and ADaM datasets against specifications and CDISC standards: structure, derivations and traceability. Issues are found and resolved before they reach your submission.
Result
You keep control of your study, see risks early and decide on facts. At the end of the project, the complete OctOver app with your data and all reports is yours.
Let’s tailor your study together
See OctOver with your own study in mind
Book a personal demo. We will look at your study together and show you how OctOver can be configured for it. If you need more, we bring in our experts and trusted service providers, up to full study conduct.