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05/03/2008
Acquisition of Fundus camera (retinal camera), Slit lamp camera and Digital electroencephalograph (EEG)
Improvements in variety of subject examinations
New instruments were acquired to further improve upon the current examinations
possible at our clinicfs Ophthalmology (visual acuity test, intraocular
pressure, visual feed testing, and ophthalmoscopic examination) and the
Electroencephalography (EEG) evaluations.
The newly acquired instruments are:
Kowa fundus camera (Model nonmyd7)
Kowa fundus camera (Model nonmyd7) can produce digital photographs of extremely high quality, which resolution is 10,000,000 pixels. By being able to take the photographs in low flash light intensity, we reduced the burden imposed upon the subjects. The camera also allows the continuous shots function, thus reducing photographing time of the subjects.
 
Digital slit lamp camera
By acquiring slit lamp unit, which takes digital photography of the results, it allows the results to be stored as a digital file. This allows the acquired data to be stored and delivery on demand.
Digital Electroencephalography unit (EEG-1200)
The newly acquired Digital Electroencephalography unit (EEG-1200) is able to produce readings of up to 250 channels and is a paperless digital filing unit. The digital EEG can be stored in the hard disk, MO disk and CD-R/RW disks. Also the results from the EEG can be produced in 3D format, therefore is able to pinpoint exactly where the electrical activity reading occurs.
24/11/2007
Presented platelet aggregation test and QuantiFERON (QFT) test at Japanese
Society of Preventive Medicine (JSPM)
At the 5th conference of Japanese Society of Preventive Medicine (JSPM)
hosted on November 24th 2007 at Ibusuki, Kagoshima, CPC clinic presented
two researches that were comprised from the compiled data. The titles of
the researches were as follows; gExamination of circadian variation of
platelet aggregation in healthy, adult maleh and gComparative study between
tuberculin skin testing and QuantiFERON TB-2G testing in healthy, adult
maleh
30/03/2007
The Acquisition of gISO15189h Accreditation from Japan Board For Conformity Assessment (JAB)
Medical Corporation Kouryokai CPC Clinic
Executive Director: Hiroyuki Fukase
This companyfs clinical laboratory worked towards the acquisition of International Standards ISO 15189 accreditation (Specific requirements related to the quality and capability of Clinical Laboratory operations). This certificate, hereby, gives notice that on March 30, 2007 the Japan Board for Conformity Assessment (JAB) formally awarded ISO 15189 accreditation.
This companyfs clinical laboratory sought to achieve third party quality accreditation from the Japan Board for Conformity Assessment (JAB), an organization that, gprovides testing and calibration laboratories with a common standard to apply while permitting third party accreditationh.
In order to guarantee that we are continuing to aim towards ever increasing standards in the quality of our clinical laboratory operations our clinical laboratory developed procedures and working practices in order to achieve this accreditation. This certificate, hereby, gives notice that on March 30, 2007 the Japan Board for Conformity Assessment formally awarded ISO 15189 accreditation.
After obtaining this accreditation, our company intends to maintain our momentum in achieving ever increasing quality standards, in order that we can meet internationally recognized standards in delivering results of the highest possible quality and reliability in the conduct of the clinical pharmacology studies we undertake on behalf of our sponsors.
[ISO 15189:2003]
ISO 15189 is an international Standard, based on ISO/IEC 17025 and ISO 9001, covering requirements for competence and quality that are particular to medical laboratories. The first edition of ISO 15189 was established in 2003.
[ISO/IEC 17025:2005] focuses on the following two elements:
Clause 4 - Management requirements
This clause specifies the requirements for sound management.
Clause 5 - Technical requirements
This clause specifies the technical requirements for the specific type of tests and/or calibrations the laboratory undertakes.
31/08/2006
Grand Opening of Kawasaki Management Office
The main objective of establishing this office was to further improve upon
our specialty of recruiting our Caucasian subjects. We have set up video
conferencing system in the Kawasaki office to better support our extensive
foreign clientele base. Please feel free to contact our new Kawasaki office
via phone, email, or connecting with our new video conferencing system.
 
05/07/2004
Press Release
CPC Clinicfs 10 year anniversary
Elderly subjects, female subjects, Caucasian subjects
Phase I Clinical Pharmacology Studies
CPC Clinic (Medical Director, Dr. Hiroyuki Fukase) is a medical institution that conducts Phase-I clinical trials in collaboration with SNBL (CEO, Dr. Ryoichi Nagata), Japanfs largest non-clinical research company. Phase-I operations commenced in November 1993 and while more than ten years have elapsed; CPC Clinic is still planning to expand and increase the quality of services the clinic provides.
Following the opening of the medical facility in October 1993, CPC Clinic conducted specialized Phase I studies in elderly and female subjects for the first time in 1994. In 2000, CPC Clinic conducted the first ever study in Japan that enrolled Caucasian subjects. In October 2002 the name of the company was changed to Medical Institution Kouryokai CPC Clinic, and in December of the same year a clinical laboratory information management system (CPC LIMS), which had been developed, in-house to streamline our operations. In August 2003 the building was extended to provide extra space in order to continue improving the quality of the services supplied.
Dr. Hiroyuki Fukase, the Managing Director and Medical Director, graduated from St. Mariana University with a Doctor of Medicine in 1985. In 1991 Dr. Fukase obtained his PhD and joined SNBL in the pharmacology research department, where he worked until becoming the medical director of CPC Clinic in October 1991.
Operation of the in-house Developed gLIMSh System
Increasing Efficiency and Decreasing Time in Conducting SDV
Following our 10-year anniversary Dr. Fukase expresses the following ambitions:
CPC Clinic has now been conducting clinical pharmacology studies in healthy subjects for more than 10 years in the beautiful city of Kagoshima, which is dominated by the magnificent and active Sakura-jima volcano. To date we have conducted more than 200 studies and currently have more than 60 members on the staff.
In December 2002, we implemented our specialized computer system for the management of clinical laboratory information (LIMS) that we had completely developed in-house. This has proved to be very valuable to our sponsors, as it has enabled them to conduct SDV with greater efficiency.
In August 2003 we extended our facility in order to obtain greater office space and to substantially expand our clinical laboratory. This enabled us to install a large size clean bench in order to conduct ex vivo assays on various active substances in obtaining early stage pharmacodynamic profiles. Additionally, the new building has many rooms for sponsors to use in conducting monitoring and auditing activities. We have received a very positive response from the sponsors about the pleasant working environment we have created.
Recently the demand has been rapidly increasing to conduct studies using our specialist volunteer panels, namely elderly, postmenopausal and Caucasian subjects (one site comparative PK studies) and we have been conducting many such studies. From now, it is our aim to continue conducting high quality clinical pharmacology studies, in accordance with the requirements of the times, and be able to contribute to increasing human welfare standards.
20/08/2003
CPC Building Extension
A ceremony to celebrate the opening of our new building was held on August 20, 2003.
The opening of our new building has enabled us to increase the ward area for the comfort of our volunteers and also includes a new Japanese style dining room. Additional space is now dedicated for PD evaluation studies and extra meeting rooms for sponsors, to conduct monitoring activities and SDV.
New office space is located on the 1st floor, the clinical laboratory is located on the second floor and new conference rooms are located on the 3rd floor.
 
 
 
05/06/2003
Conference presentation
On May 28, CPC clinicfs Medical Director, Dr. Fukase presented a paper
(Fireside Seminar) at the 67th conference of the Japanese Circulation Society
conference at Fukuoka International Congress Center.
For more details (Japanese language only) please refer to Medical Channel (http://www.medch.tv/index.nsf/Top) and select
(To enlarge, please click on the image)
05/06/2003
Introduction of CPCLIMS (Clinical Laboratory Information Management system)
For the management of clinical data generated in the process of clinical trials (phase I) from protocol writing to data output, CPC clinic has developed in-house LAN based Clinical Laboratory Information Management System (CPCLIMS). With the aim of increasing study quality and to streamline for optimal speed, we created a LIMS project team to develop the system. Following numerous system trials, we have validated the system and commenced operations from December of last yearB
The general operations of the system is as follows:
Once the protocol details have been fixed, the protocol information is entered into the system step-wise. A bar code label is then produced for each study points. The instruments in the clinical laboratory is equipped to automatically read each bar code as it measures the examination items of each sample. Following confirmation of the data output by the medical staff and staff from the clinical laboratory, the data is stored in the database.
The use of this system decreases the need for manual input and dramatically increases the speed of processing clinical laboratory data whilst also increasing data quality. The advantages our sponsors have found are that, it enables them to conduct monitoring activities with greater efficiency and reduce the time to conduct SDV. As we do not currently use electronic CRFs, the investigator fixes output data by signing the subjectsf medical records.
Regarding other examinations (vital signs, blood sampling records etc.), we are now currently investigating automated methods and systems with the aim of increasing study efficiency and quality.
17/07/2001
Dining room refurbished
The dining room of CPC has recently been redecorated to create a more favorable atmosphere for our subjects. With counters along the walls and a bright airy space, it provides the subjects with very comfortable atmosphere. We have also installed a large sized television and video for the subjectfs entertainment, during meals.
In a continuing effort, CPC is making long hospitalization periods, more agreeable and comfortable for our subjects.
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16/03/2001
The Edinburgh revision of the declaration of Helsinki
The Declaration of Helsinki is a code of ethics stating that with regards to medical research, physicians should at all times, safeguard the health of the people. The World Medical Association adopted this declaration following the 1964 Helsinki general assembly, after reflecting on the atrocities of human experimentation, during World War II.
The Declaration of Helsinki was introduced initially to provide a code of ethics for the professional body of doctors, but subsequently, GCP guidelines were adopted as basic principles for everyone, involved in the conduct of clinical research.
The Declaration of Helsinki has been amended 5 times, following its adoption in 1964 (In Tokyo 1975, Venice 1983, Hong Kong 1989, South Africa 1996 and Edinburgh 2000). Notably, the advancement in the study of Genomics were reflected in the huge amendments, made by the Edinburgh Assembly in October 2000, which also take into consideration the concerns of developing countries. Below is a brief outline of the amendments of the Edinburgh assembly meeting:
Brief overview of amendments
Structural Changes
Before the revision of the Declaration, there was a distinction between Clinical Research and Non-Clinical Research (Non-therapeutic research), but this distinction was abolished by the revision. As it will be detailed later, because genomic research is progressing so rapidly, the boundaries between Clinical researches and Non-Clinical researches were fast becoming vague that, the distinction was almost meaningless.
The World Medical Association has developed the Declaration of Helsinki, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research, involving human subjects. Medical research involving human subjects includes, research on identifiable human material or identifiable data.
One objective of gsubmitting the protocol, before initiation of a trial to a specially appointed ethical review committee,h was added and is highlighted in the objectives as follows: gThe protocol must be submitted for consideration, comment, guidance, and where appropriate, approval that must be independent of the investigator, the sponsor or any other kind of undue influenceh. The right of the committee to monitor ongoing trials was clearly highlighted.
Reflecting the concerns of developing countries
(Section B, paragraph 19, 22 and Section C, paragraph 30)
Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.
After completion of the research, all patients who participated have the right to be informed of the results of the research. In cases where Informed Consent cannot be obtained in writing by trial volunteers, non-written consent to participate must be witnessed and formally documented. This clause is particularly relevant to developing countries, where illiteracy is commonplace and people may not be able to give written informed consent.
The use of placebo (Section C, paragraph 29)
To date, situations where the use of placebo or non-therapeutic compounds were permitted was quite vague, and in this revision, it was clarified that the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.
No matter how much science advances, humans will never change. As science advances, the need for a code of ethics as a means of regulation intensifies. As people involved in the conduct of Clinical research, we want to observe the spirit of the Declaration of Helsinki and contribute to the welfare of humanity.
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI, Ethical Principles for Medical Research Involving Human Subjects.
http://www.wma.net/
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