同情用药与扩展获取
获取希望，提供关怀——为患者提供在临床试验之外获得关键研究性治疗的机会。
获取希望，传递关怀
同情用药和扩展访问项目在为已耗尽所有其他选择的患者提供挽救生命的治疗方面发挥着关键作用。在Omega CRO，我们致力于以精确和关怀促进这些项目，确保患者在临床试验之外获得关键的研究性治疗。
我们致力于提供同情用药、扩展访问和试验后访问项目，弥合临床开发与患者需求之间的差距。我们经验丰富的团队在复杂的法规、物流和伦理环境中导航，将研究性治疗送达最需要的人。
全面的项目能力
同情用药和扩展访问项目管理的每个方面都由经验丰富的专业人员处理。
法规策略和合规
在复杂的监管环境中导航，确保您的同情用药计划符合所有必要的指南。我们管理FDA扩展访问IND申请、EMA同情用药项目和TİTCK早期访问批准，提供完整的文档和机构沟通。
安全存储和物流
Turkey's first clinical trial-specific depot (est. 2003) with over 1 million IMP units securely stored and distributed. Our facilities provide secure and validated storage for investigational products with continuous temperature monitoring, chain-of-custody, and emergency distribution capabilities.
项目设计和实施
我们与您合作设计符合科学和监管标准的同情用药项目。从方案开发和入组标准到医生培训和患者招募，我们确保项目顺利实施。
患者和中心协调
我们与试验中心、治疗医生和医疗服务提供者协调以促进访问，确保治疗高效地到达患者。我们的团队在整个项目中管理医生注册、患者资格验证和不良事件报告。
我们管理的项目类型
Omega生态系统中的应用场景
How the Omega Research Ecosystem supports compassionate use programs with secure logistics, home delivery, and safety monitoring.
Omega Care
研究产品送货上门
Protocol-compliant home delivery of investigational treatments to mobility-limited patients; home-based safety monitoring and adverse event assessment for compassionate use recipients.
Omega Genetics
药物基因组学安全性筛查
Rapid pharmacogenomic profiling to identify potential drug-gene interactions and predict adverse drug reactions before compassionate use treatment initiation.
HelixLab
安全性实验室监测
Centralized safety laboratory panels (CBC, biochemistry, organ function) for ongoing monitoring of compassionate use patients, with rapid turnaround for critical values.
Omega Bio
用于治疗选择的CDx
Kit-based companion diagnostic testing to confirm patient eligibility for targeted therapies in compassionate use programs where biomarker status is required.
Omega生物样本库
长期安全性样本存档
Biobanking of serial samples from compassionate use patients for extended follow-up, post-trial safety analysis, and regulatory reporting requirements.
动物设施
临床前安全性数据支持
GLP-compliant supplementary toxicology data to support expanded access IND applications and strengthen the safety rationale for compassionate use approval.