Clinical Research Site Support
Clinical Research Site Support from Soft Home Global costs $2,100 per seat per month. That is one full time trained person, forty hours a week, working United States business hours inside your own system. One seat, one month, cancel any time.
A research site runs a second back office nobody is hired for. Source data has to reach the sponsor's system while the visit is fresh, queries answered before they age, the binder kept current, visit windows tracked, and the sponsor invoiced for what was actually done. When nobody owns that work, the coordinator does it at night, queries stack up in the week before a monitoring visit, and completed work goes uninvoiced. The seat does the administrative and data work; the coordinator and investigator keep every clinical judgment.
What the seat actually does
- Visit windows tracked subject by subject against the protocol schedule, with the ones about to close flagged early enough for the coordinator to book.
- Source data transcribed into the sponsor's EDC from your source documents, on the sponsor's timeline, once the investigator has delegated that task in writing.
- Queries worked oldest first and answered against source, with anything that turns on clinical judgment passed to the coordinator or investigator to answer.
- Electronic site file kept current: CVs, licences, training records, protocol and consent versions, IRB correspondence, filed where a monitor will look.
- Delegation and training logs kept up to date, missing signatures chased from the people who must sign them, and gaps flagged before a monitor finds them.
- Completed visits and procedures reconciled against the study budget and your billing grid, invoiced to the sponsor, and unpaid invoices chased in writing.
What it costs
$2,100
Per seat, per month, in US dollars. Full time, forty hours a week, on US hours — not per hour, not per claim, and never a share of your collections.
Compare against the other 21 roles →
How a seat starts
You issue one named login. We sign the Business Associate Agreement before it is used. We agree the numbers you will judge the seat on, which you pick and you measure. Then we train for about a week on your workflow and the seat starts. Every Friday you get a written report of what was done, what the numbers were, and what went wrong.
Questions
How much does clinical research site support cost?
$2,100 per seat per month. That is a full time person, forty hours a week, working United States business hours. Not per hour, not per claim, and not a percentage of what you collect.
Is there a minimum contract?
One seat for one month, cancellable with thirty days notice. There is no annual lock-in.
Do we have to change systems?
No. The work happens inside whatever you already use, through a named login you issue. We do not sell software and we do not route your data through anything of ours.
How quickly can a seat start?
About a week from the agreement, which covers training on your workflow, your payer mix and your system. You are not charged extra for that week.
Can the seat make eligibility, adverse-event or protocol-deviation calls?
No, and no honest supplier should tell you otherwise. Eligibility, adverse-event assessment, causality, protocol-deviation judgments and every signature that has to carry a credential stay with the investigator and the coordinator. The seat prepares the work: pulls the source, drafts the entry, assembles the document, puts the open question in front of the person who has to answer it, then records the answer once it is given. The same line holds in billing. The seat invoices the sponsor from your coverage analysis and billing grid; it never decides what is a routine cost billable to a patient's insurance.
What access does the person need, and where does our data sit?
They work inside your systems on a named account you create, with the scope you set and can revoke the same day. Nothing is copied to a system of ours. Because they will see identifiable patient information in source documents, we sign a business associate agreement first, and the person completes your site's training, GCP and protocol training before touching live data. Two hard limits. Anyone entering data or answering queries must be delegated in writing by the investigator, so the delegation log is not optional. And some sponsors and CROs will not grant EDC access to offshore staff, or bar subcontractors in the trial agreement. Check both before you sign with us.
Can they speak to our monitor, the CRO and the lab during our working day?
Yes. The seat works your US hours, so calls and emails to the sponsor, the CRO, the monitor and the lab happen live rather than overnight. Every call is logged with who was spoken to, the reference given and the outcome, so the next person to touch it does not start again. Before a monitoring visit the seat can pull the documents on the list and track each item in the follow-up letter until it is closed. The visit itself, wet-ink signatures, paper binder filing and anything else needing a person physically at the site stay with your staff.
How would we know the data entry is any good?
By counting the things a monitor counts. Days from visit to entry, days from query issued to query closed, and the share of queries that come back on the same field or the same form. Those go in a weekly report with dates attached. Early on, have your coordinator check every entry against source; move to a sample once the error pattern is clear. If the same query type keeps recurring, that is a training failure on our side, and the fix is ours: retrain the person or replace them.
We run one or two studies. Is a full-time seat sensible?
Probably not on research alone. A site with a single open study, slow enrollment and infrequent visits will not keep one person busy for a full US shift, and you would be paying for idle time. Two ways it works. Give the seat a second queue from the practice side, such as insurance authorizations, patient recall or records requests, so the research work takes the hours it needs and the rest is still useful. Or wait until a second study opens. Terms are per seat per month, paid up front, one month minimum, thirty days' notice, so the decision is reversible.
Next step
Try one clinical research site support seat for a month
$2,100 for the month. If it does not earn its keep, cancel it. Twenty minutes on a call is enough to tell whether it fits.
Or write to ops@softhomeglobal.com