Our scope
Site monitoring
Risk-based monitoring executed against your plan, not a generic template. Initiation, interim, triggered and close-out visits, on site or remote, with findings a medical monitor can act on rather than a list of typos.
Clinical services & medical device distribution
Clinical trial oversight without hiring a CRO to get it.
Feasibility, regulatory submissions, the study plans, the monitoring and the project management — ours. Statistics, safety, data and medical oversight — partner firms we contract and oversee. One agreement, one accountable party, people whose CVs you approved before they started.
I–IVPhases covered
18Countries covered
34Partner firms & vendors
140+Vetted specialists
Working with HealthHub Pharma has been a highly positive experience. From the outset, their team demonstrated a strong understanding of our needs, a commitment to quality, and a professional approach to delivering solutions. HealthHub Pharma has proven to be a trusted and capable partner, and I would confidently recommend their services to organizations looking for a professional, responsive, and results-oriented pharmaceutical partner. We appreciate the relationship we have built with HealthHub Pharma and look forward to continuing our collaboration.
We highly appreciate our collaboration with HealthHub Pharma. Their team is responsive, professional, and highly collaborative, with a strong commitment to building successful partnerships and finding effective solutions. Their thorough, detail-oriented approach and deep expertise make them a trusted and reliable partner. We truly value our cooperation with HealthHub Pharma and look forward to developing further opportunities and successful projects together.
I have had the pleasure of collaborating with Wojciech on several projects, all of which were handled professionally and successfully. HealthHub Pharma is an extremely flexible, responsive, and reliable partner, always focused on finding effective solutions and delivering results.
We highly appreciate HealthHub Pharma’s strong clinical trial expertise, professionalism, and collaborative approach. Their extensive network across Central and Eastern Europe gives access to highly qualified clinical trial professionals with a strong level of experience and specialist knowledge.
What we do
Clinical trial monitoring, project management, study documentation, feasibility and regulatory are ours. Statistics, safety, data and medical oversight come from the partner network — named firms under our framework agreement, so you still sign once.
What we run and answer for
Our scope
Project management
One named person accountable for timeline, budget and vendors, reporting in your format on a cadence you set. They chase the site contract, the courier and the missing lab manual so your team does not have to.
Our scope
Study plans & documentation
We write the plans a study runs on, and we keep them current when the protocol is amended — the revision everyone forgets until an inspector asks for it.
Our scope
Feasibility
Country and site feasibility across the region, built from actual conversations with investigators rather than a database export. You get enrolment estimates you can defend, and the countries we would drop.
Our scope
Regulatory
CTIS applications and substantial modifications, ethics committee submissions and the national specifics, tracked against the regulatory clock through to approval.
Through the partner network
Partner
Biostatistics & data management
Statistical analysis plans, randomisation, database build and validation, cleaning and lock — delivered by a partner firm we contract and oversee.
Partner
Pharmacovigilance & medical monitoring
Safety case processing and reporting, plus a qualified medical monitor on call for eligibility questions and safety decisions when your own team has no capacity.
Partner
Medical writing
Protocols, investigator brochures, clinical study reports and lay summaries, plus certified translation into the local languages your submissions need.
Partner
Labs, systems & logistics
The vendors around the study, contracted through us or brought in from your own preferred list — we oversee them either way.
Why sponsors stay
What sets us apart
Not a process we invented for the website — just how the work runs day to day.
High flexibility
Scope that can change mid-study
Add a country or extend the scope without renegotiating the whole contract.
Trusted partner
One person who answers
A named contact for your study, not a ticket queue.
Proactive problem-solving
We flag things early
If we see a problem at a site, you hear about it straight away.
One team, end to end
The same team throughout
The people who start the study are the people who finish it.
Sponsor visibility
You know where the study stands
Reporting in your format, as often as you want it.
Operational ownership
We follow things through
Contracts, couriers, vendors — we chase them until they are done.
Recruitment focus
Enrolment comes first
Sites chosen for recruitment, and we step in when one stalls.
Less management overhead
One contract, one contact
Our scope and the partner firms sit under one agreement.
Engagement
Three ways sponsors use us, and what happens between your first email and the first visit.
Functional service provision
Within the scope we run — monitoring, project management, study documentation, feasibility and regulatory — we work as a functional service provider: vetted specialists from our network placed inside your study, in your systems and under your SOPs, contracted and overseen by us. Outside that scope we bring in partner firms rather than claim a capability we do not have.
Models
How you contract for it
Most studies start in one model and move to another. Changing the model does not mean changing the people.
Model A
Visit cover
You have a team and need a region covered — a country with no CRA, a maternity leave, a burst of initiations before first patient in. A monitor from our network works to your plan and your SOPs, reports into your lead CRA, and hands the sites back with a written handover.
Fits1–15 sites, single country or region · sponsor keeps the monitoring plan and the CTMS
Model B
Embedded team
One or more specialists work inside your study team, in your systems and your meetings — functional service without a full-service contract. You direct the work; we carry contracting, insurance, GCP training records and the replacement risk if someone leaves.
Fitslean sponsor teams scaling one programme · CRA, lead CRA, PM, CTA, start-up · engagements from three months
Model C
Clinical ops oversight
We own the monitoring plan, the site network, vendor oversight and the reporting line to you, and bring in partner firms for scope we do not run ourselves. You keep the sponsor decisions; we keep the study moving between them.
FitsPhase II–III in CEE · sponsors with no internal clin-ops function · studies transferred mid-flight
From enquiry to start
From first email to first visit
Five steps. Nothing is committed before the contract.
01You
Write
A synopsis, a protocol, a country list — or just a question.
02Together
Scoping call
Thirty minutes on countries, timelines and scope.
03Us
Written view
Feasibility and staffing in writing. No charge, no obligation.
04Us
Proposal
Budget with its assumptions, and the CVs of the people who would do the work.
05Together
Contract
Framework or study-specific. Start-up begins on signature.
Partners & vendors
A network built over years — named firms and independent specialists, brought in for the scope a study actually needs.
Sponsor
- One contract
HealthHub Pharma
- Site monitoring
- Project management
- Study plans & documentation
- Feasibility
- Regulatory
Partner firms
- Biostatistics & data management
- Pharmacovigilance & medical monitoring
- Medical writing & translation
- Labs, EDC / IRT, logistics
There is no shortage of experienced clinical research people in this region. The work is knowing which of them fits a given protocol, phase and country — and confirming that what a CV claims is what actually happened.
How it is contracted is your call. We can hold the agreement and answer for delivery, or sit alongside vendors you have already chosen and keep the oversight. Either way you see who is proposed and why, before anyone is assigned.
Working in clinical research, or running a specialist firm? Send a CV or a capability note through the contact form.
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Verified trial history
References checked with the named sponsor or CRO for the studies claimed, including indication and phase.
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Training records we hold
ICH-GCP certification in date plus role-specific training, retrievable for an inspector on request.
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Insurance and agreements
Professional liability confirmed before assignment, and a CDA signed before any protocol is shared.
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First assignment reviewed
The first deliverable from anyone new is reviewed internally before it reaches you — and we tell you that it was.
Device distribution
A second business line alongside the trial work: we are the exclusive distributor of Lumoral in Poland, supplying dental practices, implantology clinics and pharmacies.
Lumoral is a CE-marked, dual-light antibacterial photodynamic therapy device for home use, prescribed and supervised by a dental practice.
It pairs a light-activated rinse with a mouthpiece that emits dual-spectrum light. The rinse binds a photosensitive compound to the plaque biofilm; the light activates it only where it has bound, and the loosened biofilm is then brushed away. Published data reports the effect on Streptococcus mutans and periodontal pathogens without the resistance associated with repeated antibacterial use, and with oral microbiota diversity maintained.
The device is developed and manufactured by Koite Health Oy, a Finnish medical device company. We work with Koite Health directly as their partner for the Polish market, so clinical training material, regulatory documentation and supply come from the manufacturer rather than through a chain of resellers.
Koite Health · Finland
CE-marked
Home use
Dual-light PDT
Exclusive distributor · PL
Indications and protocol
Implant care, before and after placementdaily · 2 weeks
Periodontal disease, treatment phasedaily · 2 weeks
Gingivitisper clinic protocol
Caries preventionmaintenance
Orthodontic treatment supportmaintenance
Halitosismaintenance
Maintenance, all indications2× per week
Frequency is set by the treating clinic. The device does not replace brushing, scaling or professional periodontal treatment — it is used alongside them.
Coverage
We cover eighteen countries directly, from Central and Eastern Europe through the Balkans to Turkey and the Caucasus. Western Europe is delivered through partner firms rather than claiming a footprint we do not have.
Covered directly
Delivered through partner firms
Countries we cover
PolandCzech RepublicSlovakia
HungarySloveniaCroatia
Bosnia and HerzegovinaSerbiaRomania
BulgariaGreeceLithuania
LatviaEstoniaUkraine
TurkeyGeorgiaArmenia
How the coverage works
Coverage across eighteen countries runs on a vetted network of independent specialists rather than a chain of branch offices. Each one is contracted for your study, works to your plan and your SOPs, and is overseen by us — with one named person accountable to you and CVs you approve before anyone starts.
Western Europe
Managed by partner firms under our framework agreements — local monitors, same contracting and the same reporting line back to you.
Study types
- Phase I
- Phase II
- Phase III
- Phase IV and NIS
- Bioequivalence (Phase I unit)
- Medical devices (MDR)
- Registry and RWE
Therapeutic areas
Allergology
Anaesthesiology & intensive care
Bioequivalence
Cardiology
Dermatology
Gastroenterology
Haematology
Haemato-oncology
Hepatology
Neonatology
Nephrology
Neurology
Oncology
Ophthalmology
Otorhinolaryngology
Paediatrics
Pulmonology
Rheumatology
Work with us
Two ways in: a framework agreement as a partner firm, or a place in the vetted network as an individual. We do not keep people waiting on a bench — we call from the network when a study needs someone, with a named assignment, a contract and a rate agreed before it starts.
Partner firm
Framework agreement
Statistics, safety, labs, EDC, writing, specialist CROs. One agreement signed once, then work when the scope of a study fits what you do.
Individual specialist
Vetted network
CRAs, project managers, start-up, regulatory, writing and medical roles. Freelance or through your own company — the route below is the same.
Roles we place
CRA and lead CRA
Study start-up specialist
Project manager
Clinical trial assistant
Regulatory specialist
Medical monitor
Medical writer
Biostatistician
Data manager
Pharmacovigilance specialist
What we ask for
- ICH-GCP certification
- Verifiable trial history
- Professional liability insurance
- Working English
- Travel for on-site visits
How joining works
- Send a CV
- Call, 30 min
- References and documents
- Framework contract
Send your CV through the contact form. We reply to everyone.
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Named assignments
You are proposed to the sponsor by name and with your CV, not placed anonymously into a headcount.
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Rates agreed up front
Rate and payment terms are in the contract before the first visit, and we do not renegotiate them mid-study.
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No exclusivity
You keep your other clients. We ask only that you tell us about capacity conflicts early.
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Firms welcome too
Specialist labs, EDC, statistics, PV and writing firms join the same way, under a framework agreement.
Contact
Send a protocol synopsis, a country list or an open question. If it fits our scope, you get a written view on feasibility and staffing, including countries we would avoid. If not, we say so and point you elsewhere.
We reply within one working day. Confidential material is shared under CDA.
Prefer plain email? biuro@hhpharma.pl