Our services
Oversight for your trials. Control for your quality system.
Tools and expertise that keep sponsors in control. OctOver brings study information and oversight together. OctoSOP provides a controlled environment for SOPs and training. Both are backed by our expertise in Data Management, Biostatistics and Statistical Programming.
Trial Oversight with OctOver
OctOver is configured entirely to your needs and gives your team the overviews and reports you need across studies and service providers.
- Configured to your study: overviews, listings and reports built around your questions
- Participant profiles, safety monitoring and data review listings with reviewer sign-off
- Expert oversight in Data Management, Biostatistics and Statistical Programming, including SDTM and ADaM review
- Internal teams and external providers can be integrated into one oversight structure. Partners may change as the study evolves. The structure stays.
OctoSOP: controlled SOP portal
OctoSOP gives your team one controlled environment for all SOPs, designed for GCP and available from December 2026.
- Controlled lifecycle: authoring with a writing assistant, four-eyes review and sign-off, versioning and archive
- Read-and-understood training with quizzes, so every training record stays current
- Complete audit trail for every change, comment and sign-off, easy to present in audits
- Ready-to-use clinical research SOP library, import of your existing SOPs and support in building your own SOP content
Expertise behind the oversight
Data Management
user-friendly & compliant
- We design eCRFs that are intuitive and easy to use
- Central data review listings help detect issues early
- Continuous query management keeps data as clean as possible
- Full traceability and audit logging with transparent documentation through database closure
Programming
submission-ready
- SDTM & ADaM programming built on clear specifications
- TLF specifications and shells aligned with the SAP and analysis requirements
- TLF programming that supports decision-making and study outcomes
- Risk-based QC, double programming, and code review
Biostatistics
clear, rigorous, reliable
- Study design grounded in solid scientific and regulatory insight
- Sample size planning and power considerations, aligned with endpoints and assumptions
- Protocol and estimand development, including endpoints, analysis concepts and handling of intercurrent events in line with ICH E9(R1)
- Consistent quality from statistical planning to the final Clinical Study Report
Quality Management
GCP-compliant & practical
- Ready-to-use SOP library aligned with ICH GCP
- Support in building your own SOP content
- Controlled document lifecycle: review, approval, versioning and archiving
- Read-and-understood training with quizzes and training records
- Complete audit trail for every change and sign-off
- Support for audits and inspections with transparent quality documentation
Free check-up consultation
Tell us where you stand and what you need. We’ll show you how OctOver and OctoSOP fit your setup, and whether expert support makes sense for your study.