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Our Team

Trust and Professionalism are well recognized traits

Expertise and capabilities in various therapeutic areas

Deeply rooted in a multicultural working environment

Global capabilities and rigorously trained

Strong connections and collaboration

  • Biostatistics

    From executive management team of global leading pharmaceutical companies or multinational Clinical Research Organizations; Average 20 years professional experience in Biostatistics; Have expertise and take leading role in CDISC(Clinical Data Interchange Standards Consortium) and DIA.

  • Programming

    Professional experience in clinical programming with multiple international biopharmaceutical companies; Expertise in in all phases of clinical trials; Familiar with different kinds of programming languages and system tools; Hold several key roles in professional associations, for example DIA and CDISC, etc.

  • Data Management

    Expertise in clinical data management with multinational pharmaceutical companies key management and technical positions; Extensive experience in different therapeutic areas; Familiar with clinical trial regulations in the US, EU, Japan and China; Rich and practical experience in global standardization and quality standards of clinical data management, overall procedures and different systems, process optimization and training system; Contributed to professional associations as well, like SCDM Annual Conference (Society of Clinical Data Management), DIA, etc.

  • Consulting

    Consortium of over 20 years global experience with broad background, such as development strategies, clinical science, portfolio management, biometrics specialization, clinical operations, quality and compliance. Experience including regional and local clinical development site establishment, FDA new drug R&D administration, regulatory strategy, IPO roadshow, due diligence, leadership in industry associations, academic contribution and joint program set up with world-class universities, plus a variety of clinical development leadership programs and roles.

  • Clinical Sciences & Medical Affairs

    A team of qualified MD, PhD and MBA professionals with abundant experience in medical and clinical sciences in multinational biopharmaceutical companies and CROs. Specialized in medical and clinical strategy development, implementation plan, trial protocol development and medical writing. Wide connections within Chinese medical community and global experts & scientific advisory boards.

  • Clinical Operation

    A highly experienced team with clinical, pharmaceutical education background. Core members have over 16 years global top pharmaceutical company experience, extensive knowledge and experience in global, regional and China local studies. Clinical trial experience cross all phases and many therapeutic areas. Clinical research and quality compliance leadership experience, such as study and site management, oversight, self-assessment and inspection readiness. Strong capabilities in working with global and local study teams. Excellent working relationship with sites and investigators. ICH GCP and local regulatory expertise related to clinical trial execution.

  • Drug Safety & Pharmacovigilance

    We have best-in-class drug safety surveillance and pharmacovigilance talents with experiences in global leading pharmaceutical companies and multinational Clinical Research Organizations. Core team, on average, has over 10 years of global drug safety and pharmacovigilance experience. The team is highly experienced in both clinical research and post-marketing drug safety. The team has profound knowledge in every aspect of global, regional, and local regulations and reporting requirements. The team develops expertise in a spectrum of safety solutions and strategies throughout the development and commercial lifecycle of products. The team has accumulated rich experience in quality management, process enhancement, leading system utilization and implementation, drug safety training as well as consultation.

  • Quality Assurance

    A group of highly experienced experts with average 14 years of GCP and GLP quality assurance and management experience. All worked in global leading pharmaceutical and CRO companies. Profound knowledge and experience in internal and external auditing, FDA and CFDA regulatory inspection, establishment of GCP & GLP compliant quality standard and framework including ISO standard system, risk assessment, vendor management, as well as extensive GXP expertise training.

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