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Lei Xie
Director, Clinical And Regulatory Affairs at Brightech International
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Work Experience
Director, Clinical And Regulatory Affairs
May 2015 - Present · 9 years and 8 months
Group Leader
Oct 2009 - May 2015 · 5 years and 7 months
Company Details
Brightech International, a CRO focused on clinical data solutions, provides high quality Biostatistics, SAS Programming, Data Management, Medical Writing, and Regulatory Strategy services since 2002. We bring expertise, experience and excellent track records to support 25+ long-term clients. We also provide specialty CDISC services and manage a sophisticated proprietary eClinical Suite (CIMS). Clinical Data Solutions Brightech is recognized as an innovator shaped by our industry-leading approach, clinical data methodology and client centric focus. We provide comprehensive end-to-end data services in clinical data management, biostatistics / SAS programming, clinical data standardization, regulatory submissions, and medical writing resulting in successful clinical trial activities. Clinical Data Intelligence Our trial design strategies streamline your clinical trial process to achieve your specific study objectives. Our biostatistical experts are capable of implementing the most complex analytic solutions. Our experienced data managers deploy optimized strategies and procedures to manage your clinical data in any system. In addition, we provide specialty CDISC services and manage a sophisticated proprietary integrated Clinical Information Management Suite (CIMS). Industry Leadership With our thought leadership and industry-leading solutions, we are a global CRO focused on clinical data solutions, providing high quality services since 2002. Our proven expertise, superior experience and excellent track record have supported over 25 long-term clients resulting in multiple successful NDA approvals.
Year Founded
2002
Social Media
Linkedin
Industry
Pharmaceutical Manufacturing
HQ Location
285 Davidson Ave Suite 504 Somerset, NJ 08873, US
Keywords
BiostatisticsClinical Data ManagementSAS ProgrammingRegulatory AffairsMedical Writing
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