Compassionate Use and Expanded Access

Accessing Hope, Delivering Care

Overview

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 investigational medicinal products reach patients in need across Turkey efficiently and safely.

Our state-of-the-art facilities, located in a secured technology park in Ankara, Turkey, are equipped to handle the storage and distribution of investigational products under stringent conditions. We maintain continuous communication with trial sites, ensuring timely and secure delivery of critical medicines. Omega CRO is proud to support compassionate use programs, leveraging our expertise in logistics and regulatory compliance to improve patient outcomes.

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SOLUTIONS

Omega CRO offers a comprehensive suite of solutions tailored to support Compassionate Use and Expanded Access programs. Our services are designed to address the unique challenges involved in distributing investigational products, ensuring that they reach patients swiftly and securely. Our commitment to quality and compliance ensures that your program not only meets regulatory requirements but also delivers reliable access to life-saving treatments. We partner with you to design and execute programs that maximize impact and support your strategic objectives.

Regulatory Strategy and Compliance

Omega CRO navigates the complex regulatory landscape to ensure that your compassionate use program complies with all necessary guidelines, maximizing its potential impact.

Secure Storage and Logistics

Our facilities provide secure and validated storage for investigational products, ensuring they are handled with care and precision throughout the distribution process.

Continuous Communication and Support

We maintain seamless communication with trial sites, ensuring that products are delivered on time and that all logistical aspects are handled efficiently.

Services Overview

At Omega CRO, we provide an extensive range of services that cater to the specific demands of Compassionate Use and Expanded Access programs. Each service is crafted to enhance the integrity and impact of your program, ensuring that patients receive needed treatments as quickly and safely as possible.

Solutıons

Program Design and Implementation

We collaborate with you to design compassionate use programs that meet both scientific and regulatory standards, ensuring clear objectives and outcomes.

Storage and Distribution Services

Our depot offers ambient, refrigerated, and frozen storage options, with continuous monitoring to ensure the integrity of investigational products.

Regulatory Documentation and Submission

Omega CRO assists with the preparation and submission of regulatory dossiers, ensuring your program complies with all necessary requirements for expanded access.

Patient and Site Coordination

We coordinate with trial sites and healthcare providers to facilitate access, ensuring that treatments reach patients efficiently and safely.

Why Choose Omega Overview

Choosing Omega CRO for your Compassionate Use and Expanded Access programs ensures partnership with an organization that combines deep industry knowledge with innovative solutions. Our comprehensive approach guarantees that your program is not only compliant and efficient but also impactful, providing hope and care to patients who need it most.

Our secure and validated facilities, coupled with our expertise in logistics and regulatory compliance, make Omega CRO a trusted partner in delivering investigational products to patients across Turkey. We are committed to facilitating access to life-saving treatments with the highest levels of quality and care.

Solutıons

Expertise in Regulatory Compliance and Logistics

Our extensive experience ensures that your program meets the highest standards, providing reliable access to investigational products.

Advanced Facilities and Distribution Capabilities

With cutting-edge storage and logistics facilities, Omega CRO delivers comprehensive solutions for compassionate use programs, enhancing their reach and impact.

Commitment to Patient Care and Access

Our dedication to facilitating access to life-saving treatments underscores our commitment to improving patient outcomes and delivering hope.