Medical Department conducts clinical trials on behalf of BJ PHDS Healthcare Research. It takes on the monitoring on the clinical trial for novel drugs, import drugs, and international GCP drugs. PHDS cultivates an experienced and professional clinical trial team with many years performance, which also provides reliable guarantee for successful completing the clinical trial in high efficiency and quality.
More importantly, the core competitive advantage of PHDS is the combination of strong human and social resources, international management model, and the most advantaged equipment.
Through years of operation and management experiences as international CRO, PHDS has integrated and unique view about the development of the enterprise and the marketing operation. PHDS has many experts in medicine, pharmacology, clinic and policies as consultants, has excellent clinical trial team that has been trained by international GCP, has years of clinical trial experience both in China and at abroad, such as cooperating with Chiron. PHDS staffs are proud of the achievements they approached.
Frequent and scheming internal training is the essential element of our success. The three fundamental elements of our success are following:
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Optimizing protocol of clinical trial. The decision makers should fully understand medicine and pharmacology, and then they could make proper decision about the clinical trial. Only the combination of systemically theoretic education and years of practices in medicine industry can shape such experts.
- Proper marketing orientation is the basic condition for the business success of the products. Correct marketing orientation plays important and essential role for the success of clinical trial.
- The successful execution of the clinical trial. To get the verified conclusion of the products.
we must operate the trial strictly according to the requirement of GCP, and all the details in the trial should be scientific, integrated, and reliable.
Clinical Trial Services
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Investigational site selection and management
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Clinical project perspective analysis and project budget management
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Protocol design and blind/double-blind study randomization
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Subject recruitment
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Clinical trial monitoring
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Safety Monitoring
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Data collection, data entry, data management and statistical analysis
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NDA document preparation
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All the work related the clinical trial should be strictly limited to the stipulation of GCP and based on the regulation of the medicine and drug management.
Professional team is responsible for the monitoring and operating the clinical trial. Before the clinical trial, according to the principal of GCP and the drug Standard Operating Procedure (SOP), the team should establish precise Protocol, Investigators Brochure, CRF and other relevant documents, train the investigators for Good Clinical Practice (GCP), and assess them. In the clinical trial process, the team should regularly or irregularly visit the study site, fill out the Monitoring Report Form, and report to the sponsor. The team should also guide the investigators to correctly collect data, to fill out the CRF truly and completely, to review the quality of the trial, and to push forward the clinical trial. Meanwhile, the team should properly settle the unexpected problems in the process and make necessary supplement and revision, to ensure that all the data could be recorded correctly and put into the database timely. After the clinical trial, the team should analyze the statistic data and make the conclusion on the clinical trial, which will provide completed and reliable reference for the clinical trial report.