Compassionate Use & Expanded Access
Accessing hope, delivering care — providing patients with access to vital investigational treatments outside of clinical trials.
Accessing Hope, Delivering Care
Compassionate Use and Expanded Access programs are pivotal in providing life-saving treatments to patients who have exhausted all other options. At Omega CRO, we are committed to facilitating these programs with precision and care, ensuring that patients gain access to vital investigational treatments outside of clinical trials.
We are dedicated to providing compassionate use, expanded access, and post-trial access programs that bridge the gap between clinical development and patient need. Our experienced team navigates the complex regulatory, logistical, and ethical landscape to deliver investigational treatments to those who need them most.
Comprehensive Program Capabilities
Every aspect of compassionate use and expanded access program management, handled by experienced professionals.
Regulatory Strategy & Compliance
Navigating the complex regulatory landscape to ensure your compassionate use program complies with all necessary guidelines. We manage FDA Expanded Access IND submissions, EMA Compassionate Use programs, and TİTCK Early Access approvals with full documentation and agency communication.
Secure Storage & Logistics
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.
Program Design & Implementation
We collaborate with you to design compassionate use programs that meet both scientific and regulatory standards. From protocol development and eligibility criteria to physician training and patient enrollment, we ensure smooth program implementation.
Patient & Site Coordination
We coordinate with trial sites, treating physicians, and healthcare providers to facilitate access, ensuring treatments reach patients efficiently. Our team manages physician enrollment, patient eligibility verification, and adverse event reporting throughout the program.
Program Types We Manage
Application Scenarios in the Omega Ecosystem
How the Omega Research Ecosystem supports compassionate use programs with secure logistics, home delivery, and safety monitoring.
Omega Care
Home Delivery of Investigational Products
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
Pharmacogenomic Safety Screening
Rapid pharmacogenomic profiling to identify potential drug-gene interactions and predict adverse drug reactions before compassionate use treatment initiation.
HelixLab
Safety Laboratory Monitoring
Centralized safety laboratory panels (CBC, biochemistry, organ function) for ongoing monitoring of compassionate use patients, with rapid turnaround for critical values.
Omega Bio
Companion Dx for Treatment Selection
Kit-based companion diagnostic testing to confirm patient eligibility for targeted therapies in compassionate use programs where biomarker status is required.
Omega Biorepository
Long-Term Safety Sample Archive
Biobanking of serial samples from compassionate use patients for extended follow-up, post-trial safety analysis, and regulatory reporting requirements.
Animal Facility
Preclinical Safety Data Support
GLP-compliant supplementary toxicology data to support expanded access IND applications and strengthen the safety rationale for compassionate use approval.
Deliver Hope to Patients in Need
Partner with Omega CRO for compassionate use and expanded access program management that puts patients first.
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