PHDS HEALTHCARE RESEARCH Co., Ltd.
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Global standards and quality systems, one-stop drug discovery and preclinical research services and solutions.
Clinical Research
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Post-IPO research
Comprehensive post-marketing research solutions
Phase IV Clinical Research: A Key Link in the Drug Lifecycle at PHDSWe provide comprehensive Phase IV clinical research services for your drug or medical device to conduct further in-depth studies after obtaining regulatory approval for market launch. Our services focus on monitoring the long-term safety and efficacy of products under widespread usage conditions, identifying any adverse reactions or new efficacy that may not have been detected in early clinical trial phases.
1. Definition and Purpose of Phase IV Clinical Research
Phase IV clinical research, also known as post-marketing clinical research, is a critical research phase conducted after a product gains market access. Our goal is to continuously monitor the safety and efficacy of drugs, assess their benefit-risk relationship in general or special populations, and explore new indications and drug interactions.
2. Importance of Phase IV Clinical Research: Discovering Rare Adverse Reactions
We identify rare adverse reactions that may not have been detected during clinical trial phases through Phase IV studies, ensuring public health safety.
- Assessing Long-term Safety and Efficacy:We evaluate safety issues that may arise from long-term use of drugs and the sustained therapeutic effects, providing scientific evidence for clinical practice.
- Expanding Applicable Populations and Indications:We explore the usage and efficacy of drugs in different populations and indications, broadening the application scope of the drugs.
3. Types of Phase IV Clinical Research: Observational Studies
Including cohort studies and case-control studies, we track and observe the efficacy and safety across different populations.
Interventional Studies:We conduct interventional studies to validate hypotheses, alter drug dosage or frequency to determine more optimized treatment plans.
4. Regulatory Requirements and Oversight
We strictly adhere to the requirements of drug regulatory authorities, including regular submission of safety reports and conducting research according to prescribed study protocols. We understand the oversight measures of regulatory agencies and ensure our research complies with all regulatory requirements.
PHDS Professional Team Consulting Services
The professional team at PHDS offers the following consulting services:
1. Strict adherence to GCP and SOP standard operating procedures.
2. Selection of clinical sites and management of multi-center trials.
3. Analysis of clinical project prospects and project management.
4. Writing clinical protocols and drug distribution.
5. Subject recruitment.
6. Monitoring of clinical services.
7. Data collection and statistical analysis.
8. Preparation of clinical submission documents.
Choose PHDS to ensure your Phase IV clinical research is efficient and compliant
We understand the importance and complexity of Phase IV clinical research. PHDS's one-stop service aims to streamline processes, enhance efficiency, and ensure your project can progress quickly and smoothly. Choosing us means choosing a trusted partner; we will work hand in hand with you to drive the success of drug development.
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Contact Information
Customer service hotline:
E-mail:customer@cnphds.com
Address: Building A, Ocean Express,66 Xia Guang Li, Dong San Huan North Road,Chaoyang district, Beijing, China
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