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WELCOME TO BIO GLOBAL PRIME

 Ensure Excellence For Better Human Health

BGP is an excellent full clinical study services and high-level strategic consulting contract research organization (CRO), providing agile clinical trials services for pharmaceutical, biotech, vaccine, and medical device/diagnostic companies. Originated from 2010 BC-Biostat Ltd. (Beijing), we are dedicated to delivering exceptional results and insights in the field of clinical research. ​

 

BGP also is acting as a bridge to help pharmaceutical and med-tech companies enter and success in China and UK/EU market.​

 

Since its start, BGP has serviced more than a hundred companies from China, EU, USA, Japan and other countries worldwide. Being your partner for clinical study service and strategic consulting, we ensure the successful execution of your clinical development program in China and EU.

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     MISION

 

To assist UK/EU companies entering China, not only to penetrate the Chinese market but also to achieve success within it, and vice versa. 

VISION

 

To pioneer the future of innovative technology and collaboratively create a better tomorrow. 

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Clinical Solutions

We provide the following services for clinical Phase I, II, III, post market, and real-world research

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1

Regulatory Affairs

  • IND & NDA Submission

  • CDE Communication Meeting Application

  • Submission Dossier Preparing

  • Gap Analysis

  • DMF/CEP Registration

  • Consulting Services

  • QC Testing Arrangement

  • Renew & Variation Application

  • Regulatory Strategy Development

2

Medical Writing

                    Regulatory Writing

  • Protocols and protocol amendments

  • Informed Consent Forms/Patient Information Leaflets

  • Clinical study reports

  • Investigator Brochures

  • Integrated summaries of safety/efficacy

  • Literature summaries

  • Clinical trial registry synopses

  • Narratives

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3

Statistical Analysis

  • Protocol design 

  • Sample size calculation

  • Randomization (IVRS/IWRS) 

  • Statistical analysis plan (SAP)

  • Statistical Programming (Double) 

  • Table Listings and Graphs

  • Blinded Topline Tables

  • Interim Analysis with Independent Data Monitoring Committee (IDMC) or DSMB

  • Futility Analysis 

  • Bayesian Analysis

  • Statistical analysis report (SAR)

  • Clinical study report (CSR)

4

Clinical Monitoring

  • Inspection and management

  • Ensure projects comply with ICH-GCP and regulations

  • Ensure the complete execution of the protocol

5

Site Management(SMO)

  • Start-up

  • Site management

  • Quality & progress

  • Site close-out

6

Data Management

  • CRF-Design (e-CRF and paper-CRF) 

  • Electronic Data Capture (EDC) 

  • Data Management Planning 

  • Database Design 

  • Data Entry 

  • Medical Coding 

  • Data Validation and Query Management 

  • Database Lock and Audit 

  • Database Documentation and Release 

  • Database programming 

7

Medical Writing

Scientific Manuscripts

  • Manuscripts

  • Critical Reviews

  • Abstracts

  • Posters

  • Symposia publications

  • Slide presentations

Funds & Grants

For startups and growing companies, money and time often conflict with each other. We are here to help innovative and ambitious business obtain suitable forms of financing at different stages of your growth. Our support is comprehensive, tailored, and ongoing, designed to unlock your growth potential while ensuring secure and effective development. 

 

Two types of financial forms are provided to ensuring you have the financial support and resources needed to succeed.

 

  •  We collaborate with various investors to ensure you have a reliable source of funding. 

  • Our highly experienced, professional and dedicated team can help you identify various local government grants and beneficial policies in China, prepare, and submit grant application on your behalf.

 

Within 5 years, we have secured 30 million US Dollars for projects at the different stage in the sector of Life Science and Health care in China. 

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Any questions? Please contact: 

​

info@bioglobalprime.com

End-To-End Support

Together, we make great things happen!

Starting business activities in a new environment is a highly challenging task. We have experienced it ourselves when we started our own business. Understanding the difficulties involved and closely working with our affiliate/partner companies in China/UK/EU, we offer you end-to-end tailored services to handle routine complexities, allowing you to focus your time and energy on what you do best.  

what can offer you:

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  • Legal matters: company register,cbusiness account, tax, patent register and IP protection.

  • Market research and feasibility report

  • Business trip and site investigation

  • Establishing partnerships and local social network

  • Office space rent physically or virtually

  • Source related science park in related industry cluster (China only)

  • Medical device and medicine manufacture (OEM/ODM) or supply chain

  • Medical device and medicine sales network

  • Cooperation with university, laboratory, science research institutions

  • Land (China only)

  • VC matching

  • Local government subsidies/grants (China only)

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Case Study

​While our core value serve as the foundation of our company, it is our achievements that have allowed us to deliver exceptional and valuable services to our clients, resulting in mutual success. 

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vaccine

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eye care devices

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vaccine

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drug

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medical devices

  • Teamwork: Fostering a united workforce dedicated to shared goals

  • Engagement: Actively and positively involving 

  • Collaboration: Building strong, cooperative partnerships with clients and colleagues

  • Harmony: Ensuring a balanced and respectful work environment for optimal productivity.

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drug

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drug

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drug

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drug

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vaccine

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medical devices

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​medical devices 

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Diagnostic reagents

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medical devices

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drug

Contact Us

The Innovation Centre, Sci-Tech Daresbury,

Keckwick Lane, Daresbury, WA4 4FS, UK
​​
Floor 2, Innovation Centre, 

No. 470, Mingzhou West Road, Ningbo, Zhejiang, China
​
info@bioglobalprime.com

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© 2023 by Bio Global Prime.

        All Rights Reserved.

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