Proof of Concept (PoC) and Pivotal Clinical Research

Proof of Concept (PoC) and Pivotal Clinical Research

As a flexible, reliable, committed CRO partner providing clinical trial development, CD BioSciences is dedicated to helping our clients get through the complex challenges and advance the drug development to completion. We provide expert CRO services for every stage of your clinical trial. With extensive experience in various therapeutic areas, we are committed to partnering with our clients to shorten the drug development lifecycle, mitigate the potential risks, and decrease the predictable and realistic costs.

Proof of Concept (PoC) and Pivotal Clinical Research

Proof of Concept (PoC) studies typically involve a small number of subjects, as well as more latitude in statistical requirements. PoC studies are to provide early evidence about if a drug is likely to be successful in later clinical trial phases. Hence, PoC studies can guide drug developers to make smarter "go or no-go" decisions about if proceeding with larger, more expensive studies in the next stage of drug development. The results of PoC studies are critically pivotal for strategic decisions in early drug clinical trial development.

Explore Our PoC Capabilities

With high-level statistician and medical experts, as well as a high efficient and experienced clinical operation team, we are experienced in designing and implementing proof-of-concept and pivotal clinical researches. To choose the best appropriate design for proof-of-concept trials and pivotal trials, we have expert statisticians who are highly experienced in trial design, implementation and reporting. Our extensive statistical expertise will ensure the best trials to fit your drug development needs. In addition, we have independent PV team and experienced medical monitors to handle the adverse events and serious adverse events during the clinical trials. Our team is committed to drug safety and surveillance.

• Our clinical operation team is located across various countries and covers major clinical trial facilities. Our regulatory experts are dedicated to meeting regulatory requirements of various agencies.
• We provide biological sample analysis services, such as population PK determination and analysis.
• We are experienced in setting up and managing independent data monitoring committees.
• In addition, we can provide unblinding services for blind clinical trials.

Our Advantages

• At CD BioSciences, we work together with pharmaceutical and biopharmaceutical clients during the early phases of drug development to demonstrate the proof-of-concept, facilitating the decisions for later phases.
• We provide proof-of-concept and pivotal clinical researches covering almost all therapeutic areas.
• We run the pivotal clinical studies under compliant regulatory guidelines.

CD BioSciences has been dedicated to conduct proof-of-concept (PoC) and pivotal clinical researches for many years. With advanced clinical operation facilities and highly experienced statistician and clinical team, we are confident in completing your PoC studies and delivering accurate and timely results to facilitate the decisions for later phases of drug clinical development. If you want to know more, please don't hesitate to contact us.