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Introduction of Biostatistics Team

         The Biostatistics team at Panacea is committed to providing a full range of statistical services in support of every step of the way in the clinical trials from design through submission.

         Our Biostatistics team is typically involved early on in the clinical trial planning process. Biostatisticians play a vital role in developing clinical program specifications from study design to sample size calculations and protocol consulting. For clinical trials underway, our biostatistics team plan and execute analyses on time and ensure high quality deliverables. Our biostatisticians are experienced in interacting with regulatory agencies, ethics committees/institutional review boards (EC/IRB) and investigators, and communicate effectively on behalf of our clients.

Biostatistics Services

       Clinical trial design

       Review and provide statistical input on protocols

       Sample size determination and statistical operating characteristics evaluation

       Specify randomization procedure and generate randomization list

       Provide statistical support to IRT setup and system management

       Develop Statistical Analysis Plans (SAP) and perform analyses

       Develop shells for statistical analysis deliverables, and review outputs

       Statistical programming

       Analysis dataset

       Tables, Figures and Listings (TFLs)

       Data and Safety Monitoring Board (DSMB or DMC) support

       Interim and final reporting

       Compose Statistical Analysis Report (SAR)

       Provide statistical review of Clinical Study Report (CSR)

       Statistical consulting

       Provide professional CDISC standardization service (generate SDTM/ADaM, Define.xml, SDRG and ADRG to support the analysis and submission)

       Provide statistical input to support clinical database setup

       Review and provide statistical input on (e)CRFs design, CRF completion Guidelines (CCGs), Data Management Plan (DMP) and Data Validation Plan (DVP)

       Support data review

       Represent Clients at Regulatory Agency Meetings

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Beijing Panacea Technology Co., Ltd. Beijing Panacea Technology Co., Ltd. is a contract research organization (CRO) engaged in medical research & development and clinical research. It devotes to p..MORE
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