Remote preliminary readiness assessment
An assessment from documents — no site visit, no demand on departments.
From documents: SOPs and quality management, the ethics committee, team composition and qualifications, training, informed consent, safety reporting, contracting capability, recruitment figures. At a smaller site, premises, equipment, metrology and product storage can also be covered remotely, from scans, photographs and video. For a large multi-specialty facility, a visit gives a more accurate result.
What it resolves
A sponsor questionnaire due in three days
Most questions concern documents, team composition, SOPs and recruitment figures. After the assessment the answers are already formulated and supported by specific documents, rather than assembled across departments at short notice.
A full list of requirements with no priorities
Instead of the complete set of requirements — those that apply to your profile, in the order in which it makes sense to close them. Mandatory items are listed separately.
Ordering an on-site audit blind
You know how much work the visit involves before you order it: how many days, which departments, whose time.
Documents scattered across departments
One list of what the facility has, what is missing and what exists only in an outdated version. From there you can work through it yourself.
Four steps, no site visit
Scope agreed
The profile of the facility, previous experience, and your own concerns. This determines which areas are covered.
NDA signed
Before the first file is sent. It binds both parties.
Documents provided
Policies, SOPs, personnel and training records, contract templates — against the list agreed at the first step.
Findings issued
A written report on the areas covered, followed by a call to discuss it.
Written findings and a call to discuss them
An assessment of what can be verified from documents
SOPs and quality management, the ethics committee, the investigator and the team, training, informed consent, safety reporting, contracting capability, recruitment.
Each gap referenced to the requirement behind it
Which document is missing, which requirement calls for it, and what it will look like if an auditor asks.
The order in which to close them
What comes first, what can be deferred, and what does not apply to your profile. Mandatory items are marked separately.
The scope of the full audit
How much work is left on site — before you decide whether to order a visit.
Depends on scope and is agreed before work begins
A facility at the planning stage and a site with three active protocols are different amounts of work. We state the figure after a short call, once the areas to be covered are clear.
The findings are for the facility’s own use. A full audit follows the same questionnaire, and what was covered remotely is not reviewed again. How the assessment is built →
Tell us about the facility and we will say where to start
A short call commits you to nothing. After it you will know the scope of the work and its cost, even if you decide to do everything in-house. We reply within one working day.