Investigator & therapeutic-area fit
Relevant study experience, referral pathways, protocol procedures and competing-study context are assessed against the programme.
Site Network & Feasibility
Evidence-led site decisions for Türkiye
CliniGA turns a protocol into a documented view of site fit, patient-population assumptions and operational readiness. Candidate sites and partners are assessed per study; availability, capacity and scope are confirmed before they enter a sponsor recommendation.
Illustrative study workflow
Clinical research
Evidence Workflow
From protocol question to sponsor-ready decision
Every stage has a defined output. Patient-pool figures, capacity and timelines remain assumptions until their evidence and study-specific conditions are documented.
- Step 1
Protocol intake
Population, endpoints, visit burden, timelines, specialist procedures and country assumptions are captured in one controlled brief.
Output: protocol assumptions and open-questions log.
- Step 2
Country & site assumptions
The target geography, therapeutic-area requirements and patient-population estimation method are defined before sites are compared.
Output: documented search frame and estimation method.
- Step 3
Readiness assessment
Candidate sites and qualified partners are assessed across people, start-up, pharmacy, laboratory, technology, safety and privacy domains.
Output: evidence-linked readiness matrix.
- Step 4
Risk-ranked recommendation
Strengths, dependencies and gaps are compared transparently; optimistic assumptions are challenged and kept visible.
Output: site scorecard and risk register.
- Step 5
Sponsor-ready package
The recommendation, oversight model, proposed KPIs and next actions are assembled for sponsor review and decision.
Output: feasibility package and workplan.
Readiness Matrix
Ten domains tested against the protocol
A site is not reduced to one recruitment number. The recommendation shows what is evidenced, what depends on follow-up and which gaps need mitigation.
Patient-population estimation
The source, time window, diagnosis pathway, eligibility filters and uncertainty behind every estimate are documented.
Team & FTE capacity
Coordinator, investigator, pharmacy, laboratory and supporting-team availability is assessed with delegation and back-up needs.
Start-up, contracts & governance
Ethics and authority inputs, institutional approvals, CDA/CTA/budget dependencies and escalation ownership are mapped.
Pharmacy & IMP readiness
Receipt, accountability, storage, dispensing, return and excursion responsibilities are checked against protocol needs.
Laboratory, sample & biomarker flow
Pre-analytics, collection, processing, storage, transport, central-lab interfaces and bioinformatics dependencies are evaluated.
Digital systems & data flow
EDC, IWRS, ePRO/eCOA, eTMF, access control, connectivity, source-data and support requirements are confirmed.
Safety & referral pathways
Emergency coverage, SAE escalation, specialist referrals and continuity arrangements are documented before activation.
Privacy, consent & engagement
Consent, GDPR/KVKK, registry, patient-facing material and approved engagement boundaries are assessed for the intended use.
Equipment & cold-chain readiness
Protocol equipment, calibration evidence, controlled storage, environmental monitoring and contingency needs are checked.
Specialist Pathways
Complex requirements stay visible
These pathways are feasibility and coordination services scoped per project. They do not imply owned facilities, automatic partner availability, certification or regulatory approval.
Early phase & advanced therapies
A higher-control feasibility pathway for complex early-phase, cell, gene, exosome or biosimilar programmes.
- Participant-protection and escalation model
- Specialist team and referral coverage
- Product and sample handling dependencies
- Intensive visit and observation capacity
- Programme-specific vendor qualification
Central laboratory, biomarkers & genomics
CliniGA can qualify partner laboratories and coordinate the sample lifecycle; laboratory ownership or test availability is never assumed.
- Pre-analytics and sample acceptance criteria
- DNA/RNA and molecular-testing workflow needs
- Method, version and bioinformatics traceability
- Storage, biobanking and retention requirements
- Temperature, transport and reconciliation controls
Rare disease & ethical patient engagement
Feasibility may include patient-journey, registry and PRO/ePRO readiness with clearly separated awareness and recruitment roles.
- Patient-journey and referral mapping
- Registry and real-world evidence readiness
- PRO/ePRO and patient-facing material review
- Ethics, consent and privacy controls
- Approved-site recruitment boundary
Medical device & preclinical vendor readiness
Qualified partners can be assessed for the defined programme; CliniGA does not present partner facilities or certifications as its own.
- Intended use and evidence-gap framing
- ISO 14155 or GLP-readiness questions as applicable
- Supplier quality and data-integrity evidence
- Equipment, calibration and maintenance controls
- Human-factors, cybersecurity or 3Rs inputs where relevant
Ethical patient engagement
Awareness and recruitment are different responsibilities
Patient organisations may support awareness, patient-journey mapping, registries and PRO/ePRO projects, but they are not recruitment agencies. Recruitment proceeds only through approved sites and applicable ethics, consent, GDPR and KVKK processes.
Participant protection first
Roles, materials, data flows and escalation routes are reviewed before any patient-facing activity is proposed.
Sponsor Deliverables
A package built for a go / revise / stop decision
Findings are traceable to the defined protocol scope and presented without exposing investigator, patient or confidential partner information.
Protocol assumptions and open-questions log
Anonymised capability summary
Evidence-linked site scorecard
Gap, dependency and risk register
Proposed oversight, KPI and escalation plan
Decision-ready next-step workplan
FAQ
What sponsors need to know before feasibility starts
Does CliniGA promise a specific number of sites or participants?
No. Site availability, patient-population estimates and recruitment assumptions are confirmed for each protocol. Estimates retain their source, time window, filters and uncertainty.
Is every centre in the network already contracted and ready?
No. CliniGA uses a scalable coordination model. Each candidate site and partner is contacted, assessed and qualified for the specific study before inclusion in a recommendation.
Does CliniGA operate its own central laboratory?
This service does not assume laboratory ownership. CliniGA defines requirements, qualifies suitable partner laboratories and coordinates interfaces when a central-laboratory or biomarker workflow is in scope.
How are patient organisations involved?
Patient organisations may support awareness, patient-journey mapping, registries and PRO/ePRO projects. They are not recruitment agencies. Recruitment proceeds only through approved sites and applicable ethics, consent, GDPR and KVKK processes.
Can this pathway support early-phase or advanced-therapy studies?
Potentially. Suitability depends on the protocol, participant-protection model, specialist capacity, product and sample handling, emergency coverage and qualified partners. These are assessed before scope is confirmed.
What does the sponsor receive?
A decision-ready package containing stated assumptions, an anonymised capability summary, scorecards, gaps and risks, the proposed oversight and KPI model, and a practical next-step plan.
Turn your protocol into a site decision
Share the synopsis, target population, study phase, key procedures and planned timeline. CliniGA will define the evidence questions and feasibility work package before contacting candidate sites or partners.