Stage 1 · Review
Protocol, criteria and visit burden.
What we do, in detail
Four functions of a clinical research site, all under institutional review board oversight.
Program 01 · Saying no to the wrong protocol
Study feasibility & start-up
Sites that accept protocols they cannot recruit for waste a sponsor's money and participants' time. We assess honestly whether the population, the schedule and our capability fit the protocol, and decline when they do not.
Stage 2 · Feasibility
Honest view of recruitment here.
Stage 3 · Approvals
IRB submission and contracts.
Stage 4 · Activation
Staff trained, site initiated.
Stage 1 · Enquiry
Questions answered, with no pressure.
Stage 2 · Pre-screen
A straightforward conversation.
Stage 3 · Screening
Against the protocol's criteria.
Stage 4 · Honest answer
Including when it is a no.
Program 02 · Criteria exist for a reason
Recruitment & screening
Eligibility criteria protect participants, not just data. We screen carefully and tell people plainly when a study is not right for them, because enrolling someone who does not fit puts them at risk and compromises the study for everyone else.
Program 03 · Take the form home
Informed consent & study visits
Consent is a discussion, not a signature. You can take the form away, discuss it with your own physician and family, and ask anything. You may withdraw at any time, for any reason, and it will not affect the care you receive anywhere else.
Stage 1 · Discussion
Risks, burden and alternatives.
Stage 2 · Your time
Take it home, ask your own doctor.
Stage 3 · Consent
In writing, before any procedure.
Stage 4 · Visits
To the protocol, with safety monitored.
Stage 1 · Source data
Recorded as it happens.
Stage 2 · Entry
Into case report forms promptly.
Stage 3 · Queries
Answered quickly, not at close-out.
Stage 4 · Regulatory file
Audit ready throughout.
Program 04 · Ready for a monitor
Data & regulatory documentation
Research is only worth anything if the data is accurate and traceable. We keep source documentation contemporaneous, respond to monitoring queries promptly, and maintain a regulatory file that stands up to an audit rather than one assembled before a visit.
Considering a study?
Ask anything first. No cost, no pressure, and no obligation to take part.