Phase IIIb-IV Trials

Phase IIIb-IV Trials

To help our clients achieve more regulatory success for approved drugs, CD BioSciences offers comprehensive suite of phase IIIb and IV clinical trial services. Our scientific leadership and strategic approaches will help accelerate the maximize the success of your novel drug development program.

Phase IIIb and IV Clinical Trials

Pharmaceutical companies are always looking for a new marketing edge through phase IIIb-IV clinical trials. Phase IIIb clinical trial is to conduct additional studies to increase patient exposure. The additional data might be submitted to agencies at the time of approval or post-approval. Phase IV clinical trial is to conduct studies to explore more indications, or focus on new endpoints, new methods to evaluate the efficacy etc. These data are submitted to agencies after the market approval. The definitions might be changed according to the specific drug development case.

Fully Realize Your Drug's Potential

To support your phase IIIb clinical trials, we provide seasoned teams with extensive scientific and therapeutic expertise. Also, our experiences and end-to-end solutions can help you launch the drug on time with top-quality. Moreover, our state-of-the-art processes and innovative technologies facilitate our clients make smarter decisions throughout the whole drug development lifecycle. For an approved drug, there still be much potential to be explored. Market approval isn't the end of the road of your novel drug. Our provided phase IV studies are dedicated to fully realizing the potential of your novel approved drug. With CD BioSciences, you can get the insights, experience to advance your drug's post-marketing studies. Our phase IIIb and IV professionals align and customize our solutions to achieve your objectives cost-effectively. We offer:

• Multidisciplinary, data-driven clinical design
• Dedicated, expert late phase trial program managers
• Biostatistics and post-marketing regulatory experts

Our Capabilities

We offer full-service, comprehensive suite of phase IIIb and IV clinical trial development solutions.

• Phase IIIb Clinical Trial Service
• Phase IV Clinical Trial Service
• Clinical Operations
• Market Access Consulting
• Regulatory and Medical Writing Services
• Biostatistics and Statistical Programming
• Project and Clinical Data Management
• Submission Services
• Regulatory Operations
• Post-marketing Safety Surveillance
• Additional Indication or Label Expansion Trials
• Comparative Effectiveness; Outcomes Research
• Epidemiology Research
• Observational; Registries
• Risk Management Programs/REMS

Highlights

• Comprehensive suite of capabilities including early development, preclinical and clinical development, launch and post-approval supports;
• Experienced elite team to minimize timeline and mitigate risk;
• Maximize the commercialization success and enhance the drug value.

To enable explore additional indications, support new market edge, evaluate the drug against a competitor, CD BioSciences offers full-service, fit-for-purpose phase IIIb and IV clinical trial studies. We are committed to fulfilling the unique needs for late phase clinical trials. Leveraging our perspectives and global resources, we are confident to assist you achieve the late phase goals. Please contact us for further communications.