Trial-ready inmonths weeks.
A reply from a person, usually within one business day.
Where do you stand today?
Tick what you already have. You will see what is missing, and one click takes it to us.
- 50+
- Years in trials
- 150+
- Trials supported
- 29
- SOPs ready to adopt
- ISO 9001
- Certified auditor on the team
Two core services. Three more when you need them.
From first call to trial-ready.
- 1
Tell us where you are
A short call about your trial, your team, what you outsource and what you already have in place.
- 2
We scope only what you need
SOPs, a quality system, GCP training or insurance, sized to your stage, with a clear quote.
- 3
We set it up with you
Proven starting points, tailored to your trial, rolled out and trained in with your team.
Built by people who've run the trials
With collectively over 50 years in clinical trials and 150+ studies supported, our team has built the SOPs, quality systems, and compliance that sponsors live or die by, for everyone from first-time biotechs to large pharma.
To get life-changing research moving by making compliance quicker, easier, and far less painful.
How many SOPs does a sponsor actually need?
Fewer than most teams expect. A sponsor package typically runs to around two dozen procedures spanning quality management, training, risk, vendor oversight, regulatory and ethics submissions, site management, the trial master file, monitoring, safety, data integrity, deviations and audit. The right number depends on how much you do yourself.
Read the full answer →How long does it take to put SOPs in place?
From scratch it can take several months. Starting from proven templates and tailoring them, most sponsors can have a working, GCP-compliant SOP set in days to a few weeks.
Do I need my own SOPs if I use a CRO?
Usually yes. Even when a CRO runs operational activities, the sponsor keeps oversight responsibilities and needs SOPs governing how it selects, manages, and oversees vendors.
When do I need a QMS for clinical trials?
Regulators expect quality management from day one of clinical development. The system can be lightweight early on and scale as you grow, but it should exist before you start trial activities.
Read the full answer →Do I need insurance to run a clinical trial in the UK?
Yes. UK regulations (the Medicines for Human Use (Clinical Trials) Regulations 2004) require appropriate insurance or indemnity to be in place before a clinical trial can begin.
Planning your first trial?
Tell us where you are. We'll get your SOPs and quality system sorted, so you're trial-ready, fast.
A reply from a person, usually within one business day.