Everything between your science and an approved product.
Engage Axella for a complete program, or for the one function you need right now. You'll work with senior people from the first call to the final report.
Regulatory strategy & submissions
The right regulatory path saves years. We help you find it, and then we do the work to get there.
- Route-to-approval strategy for drugs, biologics, devices and diagnostics
- Situation, feasibility, gap and risk analyses
- Guidance on additional non-clinical studies
- Pre-IND meeting requests, briefing packages and FDA interactions
- IND preparation and submission, annual and safety reports
- Orphan drug designation applications
- US agent and representative services for non-US sponsors
- IRB submissions and ongoing correspondence
Clinical operations & monitoring
Studies run to protocol, on schedule and ready for inspection, managed by people who have worked on both the site and sponsor sides.
- Feasibility assessment and site qualification
- Site selection, contracts and budget negotiation
- Site initiation visits and investigator training
- Routine and risk-based monitoring, source data verification
- Investigational product accountability
- Trial Master File and investigator site file maintenance
- Audit and inspection readiness support
- Study close-out and reconciliation
Site network & SMO services
Community practices are where most patients get their care. Our network of study sites across the United States brings trials to them, which helps enrollment and makes it easier for patients to stay in the study.
- Community-based physician practices, with particular depth in oncology, hematology and urology
- Extended network of affiliated physicians across specialties
- Clinical research coordinators and study nurses
- Patient identification, pre-screening and consent support
- CRF completion and timely data entry
- Visit scheduling and specimen logistics
Protocol & medical writing
Clear, scientifically sound documents written with an eye on how they'll be carried out at sites.
- Clinical protocols and amendments
- Informed consent forms
- Investigator brochures
- SAE narratives and safety documentation
- Study manuals, monitoring plans and CRF completion guidelines
Data & safety management
Clean, traceable data from the first patient, with safety events captured and reconciled as they happen.
- eCRF design and CRF completion guidelines
- Database build, data review and query management
- Medical coding
- AE/SAE reporting, tracking and reconciliation
- Protocol deviation tracking
- Database lock and audit-trailed electronic records
Biostatistics & statistical programming
Statistics shapes a trial long before the first patient enrolls. We support everything from the design of a single study to a full development program, through to regulatory submission.
- Study design, endpoints and sample size estimation
- Adaptive and group-sequential designs
- Randomization schedules
- Statistical analysis plans (SAPs)
- Tables, listings and figures (TLFs)
- CDISC SDTM and ADaM datasets and define.xml
- Interim analyses and Data Monitoring Committee support
- Integrated summaries of safety and efficacy (ISS/ISE)
- Statistical sections of clinical study reports, and publication analyses
Project management
One accountable lead, one plan and one source of truth for your study.
- Integrated project plans and timelines
- Vendor selection, contracting and oversight
- Budget management and site payment tracking
- Issue logs, escalation and risk management
- Real-time status reporting to sponsors
Integrated workflows, lower overhead.
Every Axella study runs on a unified digital operations platform covering budgets, regulatory documents, visit schedules, site payments and study data. Fewer systems and fewer hand-offs mean faster timelines and less administrative cost passed on to you.
Built on Ecosera, an open clinical research platform.
Not sure which services you need?
Tell us where your program stands. We'll recommend a scope, even if it's smaller than you expected.