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Brightech-Magnsoft Data Services LTD, founded in January 2000 by Dr. Shaw Zhang, the former Managing
Director of SAS Institute China, and located in Shanghai, China, is one
high-tech company and a Shanghai government certified software company.one of its major shareholder and partner is Brightech International (www.brightech-intl.com) founded by Dr. Xie, a very successful CRO and Biostat service company in USA.
Brightech-Magnsoft¡¯s business consists of two parts:
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| One is to
provide data management and analysis services to Pharmaceutical companies, this
part of business is operated by Brightech-Magnsoft itself; |
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| The other is
to distribute analytical software and provide related technical, training
services and business intelligence consulting (such as data warehousing, data
mining, enterprise reporting system), this part is operated by its controlled
subsidiary MagnsoftBI Consulting (more details at
www.magnsoftbi.com) |
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| Brightech-Magnsoft is
focusing its main resources in providing professional IT services and software
products to Pharmaceutical industry, ranging from new drug research
(pre-clinical and clinical data management and analysis), drug production and
marketing.
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| As one of
pioneer IT company in Pharmaceutical industry in China, we are not only
providing a full range of professional solution in clinical trials for drug
development, but also conducting clinical trial data management and analysis
services of Phase I-IV implementing the GCP and ICH-GCP. We always ensure high
quality and efficient services based on our clinical trial data and project
management platform such as ClinAdmin Systems£¨also called Magnsoft ClinAdmin-CDMS in the Chinese website£© and CTMS. |
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| As the current only
one software-based local medical marketing oriented consulting company with a
strong professional software and industry data analysis background in China, we
can provide the following services: |
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| What can BM do for you? |
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| As the current only local clinical research services oriented consulting company with a strong professional software and industry data analysis background in China, BM provide the following services: |
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All kinds of clinical data entry and management with our own tested reliable Clinical Data Management System, which has been audited to be used in our processing AstraZeneca Phase II & IV clinical data in total of 7200+ CRFs.
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Clinical data management and statistical analysis services for Phase II and Phase III clinical studies
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Data analysis for the Phase IV clinical data, from the market point of view (such as the customer preference analysis, campaign response modeling and market segmentation, etc.)
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Our own software products for Pharmaceutical industry, such as clinical data management systems, clinical trials management system (BM CTMS), PharmaCRM, PKS and BECS, etc.
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Benefits to outsource the above services
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| Make you focus on the core part of your business, that is the core medical research, market research and promotion designing. The work like data management and stat analysis, even data mining is of supporting work, time-consuming and not the core content of your business, but is fundamentally important. Put it to a professional hand and do your core works with it. |
| Reduce your cost by using a professional company, because our people and system are dedicated to do these kinds of work and the cost of these people and system are SHARED by many similar clients instead of using by only yourself. |
| Reduce the management overhead and raise the work quality, because you will only need to deal with BM as a professional legal entity with your needs put in the contract and then you get the results, no need to care about hiring and managing part-timers, training them , not to mention the cost on quality assurance. |
| In the last, you are dealing with a local company with the management style and professionalism of a modern clinical data services company. This will save the cost of both sides in communication and project management. |
| Like what BM has done in its book keeping: we outsource it because it is not our core work and our size so far does not afford to hire a dedicated high caliber accountant, but BM does have a high standard to this work, then the best and natural solution for us is to find a firm to do it for us with only half the cost we used to use our own unhappy accountant. |
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| Our Products: |
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ClinAdmin a PC stand alone application for doing work from eCRF designing, double entry and automatic checking, to the data locking and analysis, with FDA 21 CFR Part 11 applied
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GLPadmin, a PC stand-alone application for pre-clinical research data management and analysis with compliance to the new SFDA GLP regulations
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GMPguide a PC stand-alone application for GMP documents and validation management according the GMP regulations issued by SFDA
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PKS Pharmaceutical kinetic computing software
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BECS bio-equivalence and availability computing software
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PharmaStat customized clinical data analysis platform based on the FDA standard statistical tool SAS JMP
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Magnsoft PharmaCRM a tight and concise CRM application customized for managing sales representatives
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ClinAdmin Systems a comprehensive departmental level clinical data management system with FDA 21 CFR Part 11 applied
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CTMS clinical trials project management system, to timely monitor/manage the progress status of many projects and optimize the resources shared by many projects.
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BM has used the ClinAdmin Systems in our own consulting services to AstraZeneca and Beijing Kendlewits, and has built the industry good SOPs into the above software products, which make our consulting services and customers¡¯ related work done in a more efficient way and with a higher quality.
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| Brightech-Magnsoft has
used the ClinAdmin Systems in our own consulting services to AstraZeneca and
Kendlewits (a local joint venture company of Kendle International ), and has
built the industry good SOPs into the above software products, which make our
consulting services done in a more efficient way and with a higher quality. |
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| Quality Assurance |
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| BM believes one principle, the quality assurance must be implemented in the process of their daily work, these good working processes or the standard operational procedures must be implemented as much as possible into the computer system to minimize the errors made by the creative and dynamic nature of human behavior. The following is the main list of our system and our SOPs in medical marketing consulting services:
1.Electric Case Report Form (eCRF) design / 2.Database design and study setup using Magnsoft CDMS / 3.Data edit programming - SAS, JMP and SQL / 4.Data entry and verification / 5.Data validation / 6.Query resolution, using BM¡¯s proprietary query resolution system / 7.AE/SAE Medical coding with MedDRA and other dictionaries / 8.CRF/query tracking / 9.Clarification policy / 10.consistency checks / 11.Computerized edit checks / 12.Coding dictionary or clients' preferred naming convention & code sets / 13.Annotated CRF development / 14.A manual for data entry and supervising / 15.Double entry and computerized database comparison / 16.Error listing and queries generation / 17.Data security policy / 18.Internal SOP via sign-off lists / 19.With regard to market survey data analysis and marketing research based on the Phase IV clinical data, we use the industry strength data mining work bench Affinium Model of Unica Corporation and S-PLUS of Insightful Corporation, BM's team members have had over 15 years experience in the commercial data analysis and data mining applications.
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| Partial list of our clients: |
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AstraZeneca Pharmaceutical Co., Ltd
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Schering-Plough (China) Ltd.
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Shanghai Roche Pharmaceuticals Ltd.
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Shanghai Johnson & Johnson
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Chongqing Taiji Pharmaceutical LTD
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Venturepharm CRO Corp.
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Chengdu Chinese Medicine National Clinical Research Center
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Jiangsu Hengrui Pharmaceutical LTD
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What is Brightech-Magnsoft Data Services LTD?
