Our commitments
What we answer for ✓ The conclusion within 10 working days. ✓ Every finding tied to a specific requirement. ✓ Scope and cost agreed before work starts. ✓ A confidentiality agreement before the first document is shared. ✓ The report belongs to the facility: you decide who sees it. We do not promise a protocol: that is the sponsor’s decision, and it depends first of all on whether the right patients are there.
What does an audit cost? ↻ Show answerThe figure depends on the size of the facility, previous research experience, and the number of sites involved. We state it after a short call, once the areas to be covered are clear. Preparing the corrective action plan and implementing it are separate stages. For how quickly a first-time facility goes on to further protocols, see the market section. ↺ BackHow long does it take? ↻ Show answerThe assessment itself takes 1–2 working days. The report follows within 10 working days. The corrective action plan and its implementation are separate stages, and their duration depends on what has to be closed. ↺ BackIs this manageable for us? ↻ Show answerSeveral hundred facilities in Ukraine have already done it. The assessment sets out what you have, what is missing, and in what order to close it. This is the starting point for becoming a research site, and usually the least costly stage. ↺ BackWhat happens to the information you see during the audit? ↻ Show answerA non-disclosure agreement is signed before work begins. What we see is used to prepare the report for the head of the facility and is not passed to third parties. Details are set out in the Privacy Policy. ↺ BackCan you guarantee the site will be awarded a protocol? ↻ Show answerNo. The decision rests with the sponsor and turns primarily on the availability of suitable patients, which neither documentation nor our work substitutes for. We are accountable for the readiness of the site. ↺ BackCould you prepare documentation for the sponsor while we continue as before? ↻ Show answerNo. If staff do not work to the approved documents, the first monitoring visit will show it, and a site’s standing with a sponsor is difficult to restore. A document the team does not know causes more trouble at an audit than no document at all. ↺ BackMay a facility lawfully receive funds from a study sponsor? ↻ Show answerYes. Clinical trials are governed by the Law on Medicinal Products and MoH Order No. 690, which also sets out the contractual arrangements: the facility contracts with the sponsor or the CRO, and both the facility and the investigator team are paid officially. We prepare the facility for this activity. ↺ BackWho holds the relationship with the sponsor — the facility or you? ↻ Show answerThe facility and the principal investigator. We do not place ourselves between you and the sponsor: the study contract is concluded by the facility. Our role is to prepare the site and, by separate arrangement, to support the processes. The terms of any such support are set out in a contract with you. ↺ BackOn what terms does SMO support operate? ↻ Show answerTerms are determined case by case: they depend on the scope of support, the number of protocols, and which functions are transferred. There is no fixed rate; the arrangement is set out in a separate contract before work begins. ↺ BackHow much of my staff’s time will this require? ↻ Show answerProcess descriptions, SOPs and documentation are prepared by us. From your staff we require access to premises and documents during the audit, short interviews with department heads, and time for team training. The precise requirement is stated after the audit. ↺ BackCan the audit be conducted remotely? ↻ Show answerThis depends on the facility and on the quality of communication. For a smaller medical centre, where staff can provide scans of the full documentation together with photographs and video, remote work is feasible. For a large multi-specialty facility, an on-site visit allows a considerably more accurate assessment. ↺ BackWhat does the report contain, and who may see it? ↻ Show answerAn assessment by area, findings referenced to the specific requirement, a list of the documents reviewed, and a corrective action plan with deadlines. The report belongs to you; whether to show it to your owner, a sponsor or a CRO is your decision. ↺ Back
Not covered here? Write below and we will answer for your facility specifically.
