Our approach
Three working rules, and the paperwork behind them.
Most problems in an international study are not scientific. They are people not telling each other things in time. These rules exist to stop that, wherever the work runs.
01
A person, not a pool
You get named people with agreed availability. If someone has to change, we tell you before it happens, not after.
02
Decisions in writing
Anything that affects timeline, cost or scope goes into a written note the same week. Nothing important lives only in a call.
03
Bad news early
If a date is going to slip or an assumption was wrong, you hear it while there is still time to act on it.
Governance
A documented framework of Standard Operating Procedures.
Documented procedures make quality predictable. Every engagement runs on the same controlled foundation, from SOP control and training to audits, CAPA and risk management.
- Reporting rhythm
- A written status note each week and a documented review with you each month, covering progress, risks and open decisions.
- Escalation
- One named contact, a named deputy, and an agreed path to the CEO for anything that affects timeline, cost or scope.
- Handover
- At close, you receive the trial master file, the document index and the open items, so nothing depends on our memory.
General
- SOP development & control
- Document management & archiving
- Training & competency
- Quality assurance, audits & inspections
- CAPA
- Risk management
Project management
- Vendor selection & oversight
- Regulatory interaction
- Contract & budget management
- Study start-up & timeline planning
- Monitoring & site oversight
- Trial master file & reporting
