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Choosing a clinical research organization in Türkiye involves more than comparing prices. The right CRO should be able to bring local protocol feasibility, TİTCK and ethics committee processes, site capacity, data integrity and sponsor oversight into one governance model. This guide offers an evidence-based assessment framework that sponsors can use when evaluating CRO services in 2026.
1. Define the CRO scope before requesting proposals
CRO proposals are comparable only when their outsourced scope is the same. Study start-up, site selection, monitoring, project management, pharmacovigilance, data management, biostatistics, medical writing and investigational product logistics are separate work packages. Each package should explicitly state whether decision authority remains with the sponsor or sits with the CRO.
A well-prepared request for proposal includes the indication, phase, planned numbers of sites and participants, target countries, expected recruitment period, EDC/eTMF/CTMS systems to be used, and expected deliverables. This distinguishes proposals that appear inexpensive because they exclude critical activities from genuinely integrated CRO services.
- List outsourced tasks separately from responsibilities retained by the sponsor.
- Define decision and escalation authority for protocol deviations, safety reporting, site performance and vendor issues.
- Specify the acceptance criteria, timing and owner of every deliverable at the proposal stage.
2. Assess TİTCK and ethics committee experience through concrete evidence
According to information published by TİTCK, clinical trials in Türkiye operate within a framework of assessment by authorized ethics committees and permission from the Ministry of Health. A candidate CRO merely stating “we have regulatory experience” is therefore insufficient. The team should be able to explain the current application module, dossier structure, version control, question-and-answer cycle and notifications required throughout the study.
- Ask who performs pre-submission dossier quality checks and which checklist they use.
- Review how consistency is verified between the protocol, investigator’s brochure, informed consent form and site documents.
- See how questions from the authority or ethics committee are tracked by owner, deadline and document version.
- Add investigational product import, annual notifications, amendments and termination processes to the scope and responsibility matrix.
3. Test clinical trial feasibility and access to sites
Site access is one of the most important considerations when assessing a Türkiye CRO. A strong feasibility approach demonstrates a method for collecting and validating protocol-specific data rather than simply claiming an established network. Patient-pool estimates should be considered alongside diagnosis codes, lines of therapy, inclusion and exclusion criteria, competing studies and the investigator’s actual study capacity.
The number of sites is not a quality indicator by itself. Pharmacy and sample infrastructure, temperature monitoring, device calibration, coordinator capacity, source-documentation practices and investigator availability at selected sites should be verified to the level required by the protocol. Ask specifically which data were used to challenge optimistic recruitment estimates.
- Record the data source and date behind each site’s estimated number of eligible patients.
- Assess the effect of active or planned competing studies on recruitment.
- Clarify whether site coordinator support will come from the existing team or project-specific resources.
- Set decision thresholds for corrective plans, additional sites and site closure in the event of low performance in advance.
4. Review the ICH-GCP E6(R3)-aligned quality and oversight model
ICH E6(R3) treats quality as something built into study design rather than an outcome checked afterwards. Critical-to-quality factors, proportionate oversight, risk-based quality management and governance throughout the data lifecycle should be central to CRO assessment. This does not mean conducting the same number of visits in every study; it means justifying the controls needed for participant safety and the reliability of results.
- Review the SOP index, deviation and CAPA process, training-record model and vendor qualification method.
- Ask how critical-to-quality factors in the risk assessment connect to the monitoring plan and centralized data checks.
- Before contracting, determine which triggers will change the balance of remote, centralized and on-site monitoring.
- See how meetings, KPIs, quality events and decisions demonstrating sponsor oversight will be recorded.
5. Verify data management, technology and safety flows end to end
Clinical trial management is not limited to site operations. EDC setup, the data validation plan, coding, query management, protection of blinding, safety reconciliation, statistical analysis and archiving belong to the same data lifecycle. Assess the fitness for purpose of the CRO’s systems, access controls, audit trail, change management and export plan.
- Request the system inventory, validation status, user-role matrix and periodic access review arrangements.
- Define the frequency and owner of reconciliation between serious adverse events and the clinical database.
- Define quality criteria before database lock and acceptance or escalation rules for unresolved queries.
- Document the format in which data, audit trails and eTMF documents will be handed over to the sponsor at study end.
6. Structure budgets, contracts and KPIs to reduce surprises
A professional CRO contract shows more than the total price. Unit rates, assumptions, change-order triggers, third-party costs and cancellation terms should be visible. Pricing logic should be agreed in advance, particularly for variables such as site or participant numbers, visit frequency, protocol amendments, data-cleaning time and study extensions.
- Connect start-up milestones, monitoring-report turnaround, query closure and TMF completeness to measurable KPIs.
- Include key personnel and the notification, handover and sponsor-approval processes for personnel changes in the contract.
- Explicitly address subcontractor selection, quality oversight, data access and audit rights.
- Define the handover plan for data, documents, system outputs and continuing responsibilities when the contract ends.
7. CRO selection scorecard: 10 questions for the decision meeting
- Does the proposed scope cover all critical protocol activities?
- Can the TİTCK and ethics committee dossier process be explained through an example workflow?
- Are site and patient estimates based on dated, traceable data?
- Are critical-to-quality factors and risk controls linked to the study plan?
- Are the project team’s roles, experience, capacity and backup plan visible?
- Are ownership and validation status clear for EDC, eTMF, CTMS and safety systems?
- Do KPIs measure quality and on-time delivery rather than just activity counts?
- Are budget assumptions and change-order triggers explicit?
- Are subcontractor oversight and audit rights protected in the contract?
- Is study-end data and TMF handover defined in a practicable format?
Do not make the final decision on presentation quality alone. Request the same evidence set from every candidate, assess responses in a weighted scorecard, and convert critical uncertainties into contractual assumptions. This turns CRO selection in Türkiye from a matter of brand perception into an auditable governance decision.
Frequently asked questions
- What is the most important criterion when choosing a CRO in Türkiye?
- Rather than relying on one criterion, assess protocol-appropriate scope, local regulatory experience, realistic site feasibility, an ICH-GCP-based quality system, data governance and transparent budgeting together.
- Can the CRO and SMO be the same organization?
- Yes, but sponsor oversight, independent monitoring and site-level operational support should be clearly separated in the contract and responsibility matrix.
- Which documents can be requested from a CRO at the proposal stage?
- You can request the SOP index, organization and responsibility chart, example project and monitoring plans, quality-event/CAPA flow, training-record model, data protection approach and anonymized dossier-structure examples.
- Why can choosing the lowest-priced CRO be risky?
- When proposals do not cover the same scope, a low total may result from missing work packages, unrealistic assumptions or later change orders. Comparisons should use the same scope and acceptance criteria.