Clinical research: an opportunity for your hospital to grow
Within 10 working days you will know what the facility lacks for its first study — or for the next level, if studies are already running — and the order in which to close it. From there we bring the site to the state in which sponsors and CROs take it on.
Three different situations, three different tasks
A facility with no experience, one with occasional protocols and one that is growing each run into something different. There is no single answer.
What you will have
After 10 working days
A written conclusion: what in the facility already meets the requirements, what is missing — each point tied to a requirement — and the order in which to close it. The scope and cost of further work are known before any commitment.
Once the plan is implemented
Procedures the whole team works to. An ethics committee with its terms of reference and document control. Trained staff. A site profile — patient flow, indications, equipment, team — ready to send. Timing is set in the action plan.
In day-to-day work
A sponsor questionnaire is answered from the ready profile, not assembled department by department. The CROs that allocate protocols know the site. A new member of staff is working in weeks rather than months.
Four reasons to start
An additional source of funding
For running a study the facility is paid under its contract with the sponsor. The funds can go into equipment and development.
Reputation
An established research site increases confidence among peers, international partners and patients.
Clinical staff development
Working to international protocols develops clinicians, and helps attract good ones and keep them.
Modern treatment for patients
Patients reach innovative therapy before it is widely available. They stay with the facility, and they recommend it.
The research market in Ukraine is active and changing
A first study rarely stays the only one
Of 30 facilities that entered clinical research for the first time since 2023, 18 have already received a second study, mostly within a year of the first. Those that started in 2023–2024 now have four on average.
New sites keep opening, and competition for studies is growing.
We work with facilities of every kind
Private clinics
Unlocking the commercial side and building the processes international trials expect. An investment that can pay back on the first study, if recruitment holds up.
Municipal and departmental hospitals
Patients get expensive drugs and investigations paid for by the study, and the hospital spends less of its own money. Extra funding without adding to the budget.
Research institutes and Ministry of Health facilities
International protocols give an institute access to drugs and methods not yet in clinical practice, publications in international journals and a place in research networks — on the clinical base and staff it already has.
How we help
You know where the facility stands
Readiness assessment across premises, equipment, pharmacy, laboratory, document control, ethics committee, SOPs and personnel. The output is a list of gaps, each tied to a requirement, and the order in which to close them.
The team works to one set of rules
A quality management system: SOPs, work instructions, policies and logs written for your facility. Processes stop depending on one person and are ready for sponsor monitoring and audit.
An ethics committee that does not hold up the start
Terms of reference, SOPs and document control for the ethics committee, so that study materials are reviewed in the facility under a clear procedure.
Everyone knows their role in a study
Staff training in ICH-GCP, study roles and the site’s own SOPs — with the training records a sponsor checks before the start.
Sponsors and CROs know the site
Site promotion: we build the site profile and present the facility, its sites and its investigator teams to sponsors and CROs, in Ukraine and abroad.
Decisions based on data
Market analytics: the state of clinical research nationally and in your region — who is nearby, in which indications, and which protocols you can realistically compete for.
SMO support
The clinical side of the study remains with the facility. We take the operational side: coordination, documentation, interaction with the monitor, equipment readiness and the record of payable activity — the work that otherwise takes investigators’ time.
- Running the study from feasibility and the site initiation visit through to close-out
- A study coordinator on site — ours, or trained from your own staff
- Source documents, CRFs and monitor queries answered within the agreed time
- Recruitment logistics: screening, visit scheduling, handling of product and samples
- Equipment control: verification, servicing, metrological compliance
From assessment to an operating site
Current-state assessment
We look at where the facility starts from: building this up from scratch, or developing what already works — and what either takes. On site or remotely.
Report and action plan
A report on the current state of the facility and an action plan listing measures and deadlines.
Plan and contract
What we do, in what order and by when is fixed in the contract before work starts.
Implementation
We put the procedures in place, train the team and send the site profile to CROs. After that, operational support for studies where needed.
Worth reading before we talk
An assessment with no site visit and no commitment
Most of what has to be assessed can be covered from documents. Findings within 10 working days.
How it worksWhat the report is based on
MoH Order No. 690, ICH E6, the rules on metrology and data protection, and findings from real inspections — so that the areas where sites most often fail are the ones examined.
How the assessment is builtA stronger site means more studies
What established processes give the principal investigator and the team: more protocols and better sponsors, and where wanted, a site of their own.
The section for investigatorsWhat 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.
Worth settling before we speak
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.