Full service for biotech
We run complete studies for biotech sponsors: feasibility to clinical study report, contracted directly with you. 13 studies delivered end to end, for eight sponsors, five of them US or EU biotechs.
The delivery chain
- Study design and protocol development
- Feasibility and country selection
- Site selection and qualification
- Regulatory authority and ethics submissions
- Site contracts and budget negotiation
- Study start-up and site initiation
- Monitoring — on-site, remote and central
- Data management
- Medical monitoring, safety submissions and medical review
- Quality audits
- Biostatistics
- Database lock, medical writing and the clinical study report
The function matrix
In-house means our own employees. Oversight means a specialist vendor does the work under our direct management and supervision. Partner means a qualified vendor contracted and managed by us.
Four functions are delivered by qualified partners under our management — the same arrangement every mid-size CRO operates. We state it rather than leave it to be discovered at vendor qualification.
| Function | Delivered by |
|---|---|
| Study design and protocol development | In-house |
| Feasibility, country and site selection | In-house |
| Regulatory authority and ethics submissions | In-house |
| Site contracts and budget negotiation | In-house |
| Study start-up and site initiation | In-house |
| Project management | In-house |
| Monitoring — on-site, remote, central | In-house |
| Medical monitoring | In-house |
| Data management | In-house |
| eCRF and EDC design and validation (also available through a partner) | In-house |
| Safety submissions and medical review (also available through a partner) | In-house |
| Medical writing and clinical study reports | In-house |
| Quality assurance and quality audits | In-house |
| Certified translation and localisation | In-house |
| Import, export and clinical logistics | Oversight |
| Biostatistics | Qualified partner |
| Statistical programming | Qualified partner |
| Central laboratory services | Qualified partner |
| GLP bioanalysis for bioequivalence | Qualified partner |
Systems
We work in Chronicles for CTMS, EDC and eTMF, and contract Medidata Rave or CRF Online where a sponsor requires their own platform.
Large and multi-region studies
For large and multi-region programmes we work through approved vendors for worldwide logistics, central laboratories, couriers and comparator sourcing.
Commercial models
Unit-based as standard, with milestone-based and FTE models available. No non-billable charges.
What we do not do
We do not offer pre-clinical research or contract manufacturing. Everything we do is clinical.