临床试验
Comprehensive support from protocol design to final study reports — covering Phase I through Phase IV across all therapeutic areas.
端到端临床试验管理
As Turkey's first CRO, established in 1997, Omega CRO brings over 25 years of experience in managing Phase III and IV clinical trials and post-marketing surveys. Our full-service capabilities span the entire clinical development lifecycle — from initial protocol design and regulatory submissions to site management, monitoring, data analysis, and final clinical study reports.
我们通过全面的临床研究服务和协作方式，支持生物技术、制药和医疗器械公司加速其医疗产品的开发。我们经验丰富的团队与申办方密切合作，确保从初始概念到监管提交的每个方面都经过精确规划。
I–IV期临床试验专业能力
Phase I
首次人体安全性、药代动力学、健康志愿者或小规模患者队列中的剂量探索。
Phase II
概念验证、疗效信号、剂量优化和目标患者人群中的安全性。
Phase III
关键性注册试验，纳入大规模患者队列以确认疗效和安全性。
Phase IV
上市后监测、长期安全性、真实世界有效性和新适应症。
全面的试验能力
您的临床试验的各个方面，均由经验丰富的专业人员一站式管理。
方案设计和研究规划
符合监管要求的科学严谨的方案设计、样本量计算、终点选择和统计分析规划。
注册申报
Comprehensive regulatory affairs support including IND/CTA preparation, ethics committee submissions, and agency communications (TİTCK, EMA, FDA).
中心选择和管理
由经验丰富的研究者组成的全球中心网络，快速的中心启动和主动监查，确保GCP合规和数据质量。
数据管理和生物统计
Integrated data management, electronic data capture (EDC), statistical analysis, and medical writing for clinical study reports (CSR).
安全性和药物警戒
整个试验过程中的专门安全性监测、SAE管理、定期安全性报告和基于风险的质量管理。
IMP供应和物流
Turkey's first clinical trial-specific depot (est. 2003) with secure import, storage, distribution, and destruction of investigational products.
为何选择土耳其开展临床试验？
Turkey offers a strategic advantage for conducting clinical trials due to its well-established regulatory framework, experienced investigators, diverse patient population, and cost-effective site operations. Omega CRO's direct presence in Türkiye, TRNC, USA, and Kosovo — with partnerships across the EU and MENA — ensures efficient enrollment and high-quality data across multi-regional studies.
Omega生态系统中的应用场景
How the Omega Research Ecosystem supports clinical trials with integrated laboratory, home-based, and diagnostic solutions.
Omega Care
居家患者访视
Turkey's first dedicated in-home clinical trial visit service (est. 2019). Protocol-compliant home sampling, PRO collection, and follow-up that reduce site burden and improve patient retention.
Omega Genetics
基于生物标志物的患者分层
用于精准医学试验中患者选择和反应监测的药物基因组学分析、伴随诊断检测和分子生物标志物分析。
HelixLab
中心安全性实验室
Protocol-aligned safety panels (hematology, biochemistry, coagulation, urinalysis) with standardized pre-analytical workflows across all study sites. ISO 17025 accredited.
Omega Bio
伴随诊断试剂盒
Kit-based assay standardization for biomarker and immunogenicity testing, ensuring lot-to-lot consistency across multi-country trials.
Omega生物样本库
纵向样本生物样本库
Multi-temperature biobanking of serial serum, plasma, and tissue samples enabling retrospective biomarker analysis and future-proofing trial data.
动物设施
从临床前到临床的过渡
GLP-compliant toxicology, pharmacology, and safety studies to support IND-enabling packages before first-in-human dosing.