PHDS participates the Chinese Partner of US-China 1000 SME Partnership Program |
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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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| 1. |
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. |
| 2. |
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. |
| 3. |
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.
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. |
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