FAQ

A CRO (contract research organization) plans, runs and reports clinical trials on behalf of pharmaceutical and biotech sponsors. As Omega CRO we manage the entire study under one roof — Phase I–IV clinical operations, regulatory affairs, data management and central laboratory services. See our CRO services page for the full scope.

Since 1997. As Türkiye's first CRO we have completed 1,226 projects for more than 170 sponsors, ranging from global pharmaceutical companies such as Pfizer, AstraZeneca and Sanofi to biotech ventures, academic centers and public institutions. You can browse all of them in our reference list.

We deliver clinical operations, regulatory affairs, data management and biostatistics, medical writing and the HelixLab central laboratory under one roof — sponsors never carry the burden of coordinating separate vendors. Studies run GCP-compliant, and our quality management system is certified to ISO 9001, ISO 27001 and ISO 17025. See our certifications page for the full set.

We work with global pharmaceutical companies, biotech firms, the local pharma industry, university and training-research hospitals, patient associations, and public institutions such as TÜBİTAK and TİTCK. In scale we serve everything from single-center rare-disease studies to multi-center Phase III programs — sample projects are on our case studies page.

We cover all phases from Phase I to Phase IV, from first-in-human studies in healthy volunteers to post-marketing observational programs. We also have experience in bioequivalence studies, vaccine studies and cell-gene therapy programs. See our study types page for the full range.

We provide GCP-compliant monitoring covering site initiation, periodic monitoring and close-out visits, plus remote monitoring where appropriate. Source data verification (SDV) scope and visit frequency are tailored to each protocol's risk profile — details are on our services page.

We run the entire site relationship — site selection and feasibility, revolving-fund agreements, site file management and investigator payments. Our project management approach protects the timeline and budget with a single point of accountability.

We plan enrolment with site-level forecasts, volunteer outreach strategies and reminder mechanisms; the TURP remote-monitoring infrastructure enables between-visit contact and early drop-out signal tracking. Our full approach is on the site and recruitment page.

Our experience spans oncology, hematology and rare diseases in particular, plus cardiovascular, endocrinology, neurology, infectious diseases and vaccine studies — the 1,226 completed projects spread across these areas. See our therapeutic areas page for area-by-area detail.

Türkiye uses a dual-lock system: both the TİTCK suitability letter and ethics committee approval are required, and the reviews run in parallel. We file your dossier through KAM with e-signature, respond to deficiency letters and manage the post-approval start-up. The step-by-step walkthrough is in our regulatory guide.

All patient-facing material — the informed consent form (ICF), patient brochure and digital engagement materials — plus the protocol summary must be in Turkish; scientific documents such as the protocol and investigator's brochure are accepted in English. Our medical translation team handles this localization too — details in the regulatory guide.

We report fatal or life-threatening SUSARs to TİTCK within 7 days of sponsor awareness and other SUSARs within 15 days, in structured format through the National SUSAR Module. Our team also prepares and schedules periodic safety reports. Timeline details are in our regulatory guide.

A substantial modification is a change to an authorised clinical trial that is meaningful for safety or scientific integrity — a new indication, a dose-regimen change or updated safety information. We file the amendment to TİTCK and the ethics committee through KAM and do not implement it before approval, except urgent safety measures. For canonical term definitions see our regulatory glossary.

To run a clinical trial in Türkiye, the sponsor must apply through a representative established in Türkiye; all official correspondence and responsibilities run through that representative. Omega can take this role — from dossier preparation to approval and study conduct. The full process is covered in our regulatory guide.

We provide end-to-end data management — case report form (CRF/e-CRF) design, database setup, data entry and query management, medical coding, through to database lock; processes are aligned with ALCOA+ principles. See our technology page for the infrastructure.

They cover sample-size calculation, statistical analysis plan (SAP) preparation, interim and final analyses, and standard table-listing-figure (TLF) outputs. Randomization schedule design and IWRS integration are also run by our teams. Our full approach is on the data science page.

Study data are managed per ALCOA+ principles — attributable, legible, contemporaneous, original and accurate; our quality management system is ISO 9001 certified and laboratory services ISO 17025 accredited. Our quality assurance team continuously monitors SOPs and inspection readiness. You can review our quality assurance approach.

Our information security management system is ISO 27001 certified; study data live in access-controlled systems, personal data are minimized per KVKK (Turkish data protection law), and retention-destruction policies are defined. Details on personal data processing are in our KVKK privacy notice.

It covers protocol and synopsis preparation, ICF and patient-brochure localization, clinical study report sections and scientific communication materials. We also manage which document must be prepared in which language per regulatory requirements. Full scope is on our medical writing page.

Yes — from literature review to abstract preparation, manuscript writing, journal-compliant formatting and submission handling; Turkish-English medical translation is part of the same team. Samples of our writing appear on our blog page.

Yes; we provide Turkish-English medical translation for patient-facing materials, protocol synopses and regulatory correspondence. Translations stay consistent with our controlled regulatory terminology (clinical trial, substantial modification, SUSAR and so on) and aligned with legislative language. Details are on our medical writing page.

HelixLab is Omega's central laboratory, providing analysis of clinical trial samples, biomarker management and sample storage from a single point — so sample logistics and laboratory data are managed end to end. Its full services are on the HelixLab page.

Clinical chemistry, hematology, coagulation, immunological assays and study-specific biomarker panels are the main groups; method validation and custom panel development are also offered. The laboratory operates under ISO 17025 accreditation. The assay scope is on our central laboratory page.

Our biorepository offers categorized storage at -80°C; shipments move with temperature-logged transport and an unbroken cold chain. Biorepository management aligns with ISBER principles, and export shipment permits are handled by us where needed. Details are on our biorepository page.

Laboratory services are ISO 17025 accredited, information security ISO 27001 certified and the quality management system ISO 9001 certified; biorepository management aligns with ISBER principles. The full set of certificates is listed on our certifications page.

TURP is our remote-monitoring and digital participant-engagement platform for clinical trials; it combines between-visit contact, participation reminders and data flow in one system. That improves enrolment and retention while reducing site burden. Its full capabilities are on the TURP page.

Yes — Omega IWRS delivers randomization and investigational product supply-allocation management; both server-based and study-specific configurations are supported. System details are on our technology page.

Yes; alongside digitized processes from e-CRF design to digital archiving, our AI-supported services accelerate medical writing and data science workflows. See our AI-supported services page for the scope.

We start with a scoping discussion: study design, service scope and timeline are clarified, then we issue an itemized proposal. You can begin through our quote form or the contact page.

On the regulatory side, TİTCK approval for complete dossiers is typically 4–6 weeks in practice; ethics review runs in parallel and site initiation follows the approvals. The overall calendar depends on study design — timeline details are in our regulatory guide.

Personal data are processed in KVKK compliance: data are minimized, access rights are defined, and retention-destruction periods follow policy. Contact-form IP addresses are stored anonymized. Details are in our KVKK privacy notice.

Open positions are listed on our careers page, where you can submit your CV. General applications are considered even without a matching posting.

You can reach us through the form, phone and e-mail on our contact page; a dedicated quote form is available for proposals. Requests are routed to the responsible team.