IOWISZ SMO

Clinical Trial Site Development & Management.

We turn hospital capabilities into a structured clinical research operation — from patient-potential analysis and site readiness to feasibility, start-up, recruitment and sponsor relationships.

Clinical trials should be a hospital capability — not an extra task for one physician.

A sustainable site needs ownership, coordination, processes, budgets, metrics, patient access and a clear interface with sponsors and CROs. We design that operating model around the hospital's real clinical strengths.

The goal is not to win one study. The goal is to build a site that sponsors want to return to.

01Site Readinessclinical, operational and economic readiness
02Fast Start-upfeasibility, budget, CTA, activation
03Recruitmentthe core performance metric of a site

We start with patients.

Before choosing therapeutic areas, we assess which patient populations genuinely move through the hospital and its outpatient pathways. We then connect this patient access with investigator capability, diagnostics and sponsor demand.

Patient Potential Map

A practical map of populations, diagnoses, procedures, therapeutic areas and referral pathways that can support future feasibility and recruitment.

patient-population analysis
therapeutic-area selection
investigator mapping
diagnostics & infrastructure
Site Profile
feasibility readiness

Fast feasibility and predictable start-up.

Strong sites respond quickly, estimate patient potential credibly and have a defined internal contracting path. We build a repeatable process from sponsor enquiry to site activation.

FEASIBILITY
PATIENT REVIEW
PI DECISION
BUDGET & CTA
START-UP
FIRST PATIENT

Where data and investigator availability allow, a site may adopt an internal feasibility-response target of 48–72 hours. We treat this as an operating objective, not a public guarantee.

Study budgets must be calculated, not accepted blindly.

We map protocol procedures, physician and coordinator time, nursing, pharmacy, laboratory, diagnostics, hospital resources, archiving and overhead. The site should understand its true per-patient delivery cost before negotiating sponsor budgets.

Recruitment is the KPI that matters most.

A site is valuable when it can find and enrol the right patients. We design recruitment around hospital populations, outpatient clinics, referral physicians and — where appropriate — partner sites.

Patient identification

Turn existing care pathways into structured screening and referral opportunities.

Recruitment funnel

Track potential patients → pre-screening → screening → enrolment → retention.

Referral network

Build relationships with clinics and physicians outside the immediate study team.

Performance dashboard

Monitor feasibility, conversion, screening, enrolment, recruitment vs target and CTA timelines.

Business development for the site.

Hospitals should not depend solely on random study invitations reaching individual investigators. We build a professional Site Profile, therapeutic portfolio and a structured sponsor/CRO outreach pipeline.

A single point of operational coordination.

We create an interface between sponsor/CRO requirements and the hospital's investigators, administration, pharmacy, laboratory, diagnostics and finance functions.

What does the hospital gain?

Financial

Clinical trials may create additional revenue from protocol procedures, diagnostics, personnel, pharmacy, laboratory, infrastructure and administrative overhead.

Medical staff

Research experience, professional development, international collaboration and additional remuneration can strengthen physician attraction and retention.

Patients

For eligible patients, trials can provide access to innovative therapies, additional diagnostics and closer monitoring.

Organisational

Research professionalises documentation, quality systems, cross-department coordination and operational discipline.

Strategic

An active research site strengthens the hospital's profile and opens routes to academic, pharma, biotech and MedTech partnerships.

R&D platform

A mature trial operation creates the foundations for investigator-led studies, validation projects and broader innovation activity.

Well-organised clinical research can create value for the hospital, its physicians and its patients at the same time.

Hub & Spoke: patient access beyond one hospital.

A lead site can provide operational coordination, SOPs, quality, sponsor relations and data discipline, while partner hospitals, clinics or referring physicians extend access to patient populations.

HUB SITECOORDINATIONPARTNER SITESREFERRAL NETWORKPATIENT ACCESS

This model can be especially valuable where relevant patient populations are distributed across regional care pathways.

Three stages of development.

01Site Readinesspatients, investigators, infrastructure, processes and economics
02Site BuildSOPs, Site Profile, feasibility, CTA, budgets and coordination
03Site Growthsponsor relations, pipeline, therapeutic areas and network scale

FAQ

Does the hospital need previous clinical trial experience?

No. We can start with a structured site-readiness assessment and build the operating model from the ground up.

Can we start with one department?

Yes. In many cases the best starting point is one to three therapeutic areas with strong patient access and engaged investigators.

Do you support sponsor and CRO outreach?

Yes. Site positioning, business development and sponsor/CRO relations can be part of the IOWISZ SMO model.

Do you take medical responsibility for the study?

No. Medical and investigator responsibilities remain with the investigator and research site in accordance with the protocol and applicable regulations.

Start with patient potential.

If the population and clinical capability are compelling, we can build the site around them.

Assess your site