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Focused Leadership: Building Enduring Partnerships in CRO Services
From development to post-market phases, we leverage our expertise and resources to drive your program’s success. Contact us today to learn how we can help you achieve your goals with precision and dedication.
Evaluating Bio-similarity: Comprehensive Comparability Studies in Biosimilar Development
At COD, we pride ourselves on our robust and rigorous approach to biosimilar development. Our comprehensive comparability studies with reference medicines provide compelling evidence of our expertise and commitment to quality. These meticulously crafted data packages are designed to ensure no eloquent clinical differences in key areas, including:
- Efficacy
- Safety
- Immunogenicity
Vaccine Research and Development: Advancing Global Health
We are dedicated to advancing global public health through our extensive vaccine studies. Our work plays a crucial role in combating life-threatening and debilitating diseases worldwide. With a commitment to excellence, we offer comprehensive capabilities that cover every aspect of vaccine research and development.
Our Expertise in Vaccine Studies:
- Adaptive Trial Designs for Rapid Response
- Integrated Data Analytics
- Global Network of Clinical Sites
- Advanced Immunogenicity Assessment Techniques
- Proper Bio-sample storage & Handling
Medical Device Studies: Comprehensive Clinical Research Services for Medical Devices
Our dedicated team of experts ensures that your medical device studies meet the highest standards of quality, compliance, and efficiency. With ISO 13485:2016 trained and certified professionals, an experienced Materiovigilance safety team, and dedicated SOPs for functional and operational deliverables, we guarantee service excellence. We comply with EUMDR/MDR and Investigational Device Exemption (IDE-21CFR Part 812) requirements for Premarket Approval (PMA) applications or Premarket Notification 510(k).
We offer a full spectrum of services tailored to meet the unique needs of medical device trials. Our expertise includes:
- Drug-Device Combinations: Drug-Eluting Stents, Inhalers, Transdermal Patches etc
- Invasive Devices: Surgical Instruments, Implants etc
- Non-Invasive Devices: Diagnostic Imaging Equipment, Therapeutic Devices etc
Growing Portfolio
We continually expand our expertise, fostering innovation and achieving significant results across various specialties and product lifecycles. Our ever-growing portfolio encompasses, but is not limited to:
Real-World Evidence (RWE) Studies
As we continue to grow, COD is poised to expand its expertise and experience in Real-World Evidence (RWE) studies. We are committed to developing robust methodologies and leveraging diverse data sources to generate meaningful insights. Our upcoming capabilities in RWE will support regulatory submissions, market access, and clinical decision-making, ultimately driving better patient outcomes and strategic healthcare advancements.
Request for Proposal
From development to post-market phases, we leverage our expertise and resources to drive your program’s success. Contact us today to learn how we can help you achieve your goals with precision and dedication