PHDS HEALTHCARE RESEARCH Co., Ltd.
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Clinical Research
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Phase I clinical trial
Excellent Phase I Clinical Research Services
Phase I Clinical Research: The Starting Point for New Drug Human TrialsAt PHDS, we recognize that Phase I clinical research is a critical first step in the drug development process. Our professional team is dedicated to the preliminary assessment of drug safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers or patients with specific diseases, providing a solid foundation for your new drug development.
1. Definition and Purpose
PHDS's Phase I clinical research services focus on the preliminary assessment of new drug responses in humans, determining safe dosage ranges, and providing foundational data for subsequent clinical trial phases. Our goal is to ensure that your drug has undergone rigorous safety and tolerability assessments before entering broader clinical trials through precise scientific methods.
2. Study Subjects
Our study subjects are carefully selected, including healthy volunteers and patients with specific diseases, to ensure the accuracy and relevance of research results. We implement strict screening processes, including comprehensive physical examinations and laboratory tests, to ensure the safety of participants and the quality of research data.
3. Research Content: Safety and Tolerability Assessment
Our safety and tolerability assessment services involve gradually increasing drug doses while closely monitoring participants' physical responses to determine the maximum tolerated dose (MTD). This process is crucial for identifying drug safety.
4.Pharmacokinetics Research
We use advanced analytical techniques such as liquid chromatography-tandem mass spectrometry (LC-MS/MS) to measure the concentrations of drugs and their metabolites, calculating key pharmacokinetic parameters to provide scientific basis for developing rational dosing regimens.
5. Pharmacodynamics Research
Although Phase I studies primarily focus on safety and pharmacokinetics, we also conduct preliminary observations of drug efficacy to gain initial insights into the pharmacodynamic characteristics of the drug.
6. Research Design and Methods: Dose Escalation Design
We employ dose escalation design schemes, such as the traditional 3+3 design, to ensure participant safety and adjust the dose escalation plan based on participants' responses.
7. Randomization and Blinding
To reduce bias, our Phase I clinical research employs randomization and blinding methods, including single-blind and double-blind designs, to ensure the objectivity and accuracy of research results.
PHDS Professional Team Consulting Services
PHDS's professional team provides 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. Clinical project feasibility analysis and project management.
4. Clinical protocol writing and drug distribution.
5. Subject recruitment.
6. Clinical service monitoring.
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, improve efficiency, and ensure your project can progress quickly and smoothly. Choosing us means choosing a trusted partner; we will work together 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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