Biostatistics_Elixir Clinical Research

Professional Teams Led By Experienced Experts In Clinical Development.

The Biostatistics and Computational Science Department of Elixir Clinical Research, centered on patient needs, is committed to high-quality, efficient, innovative and compliant biostatistics and computational services to provide clients with a better clinical trial experience. Through years of technology accumulation, solid biostatistics knowledge and rich experience in the therapeutic area, we are capable of deeply and thoroughly analyzing all levels of clinical research to ensure the on-time and high-quality delivery of projects.

Comprehensive Experience Of Customized Biostatistical Services

Statistical analysis plan, analysis implementation, and results report

· Statistical Analysis Plan (SAP)

· Mock-up Shell

· Statistical programming, validation and presentation of analysis results for ADam and TLFs

· PK/PD statistical analysis

· Data Monitoring Committee (DMC) related statistical analysis support

· Interim analysis

· Exploratory analysis, sensitivity analysis, Health Authority (HA) response assistance

· Integrated summary of safety and integrated summary of effectiveness (ISS/ISE)

· Statistical Analysis Report (SAR) writing, CSR statistical section writing and review

CDISC data standardization and electronic data submission

· Establish conversion and analysis datasets that meet CDISC SDTM/ADaM criteria

· Annotate CRF (aCRF) generation and QC

· SDTM/ADaM define.xml generation and QC

· Preparation of Study Data Reviewer's Guide (SDRG) and Analysis Data Reviewer's Guide (ADRG)

· Data submission services to regulatory authorities (NMPA/FDA/PMDA/EMA)

· Data and statistics-related eCTD technical support

Clinical trial design

· Preparation of relevant sections of clinical trial protocol

· Sample size calculation

· Clinical trial protocol discussion and recommendations

Clinical trial randomization

· Randomization protocol and implementation

· Study drug immediate coding

· IWRS randomization service support

Aim for the benefit of patients and clients

We apply quantitative scientific methods, innovation, consultation, and computing services to clinical research and regulatory submissions and are committed to being a pioneer in the industry

Team

50% of employees hold higher education degrees (masters, doctorates) and have robust knowledge and experience in experimental design, statistical methods, and global regulatory requirements.

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Experience

An average of at least 5 years of clinical trial experience, involving disease areas such as oncology, cardiovascular, diabetes, respiratory, infection, immunity, digestion, vaccines, etc.

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Achievements

Participated in at least 200 clinical trials and successfully submitted new drug applications to regulatory authorities.

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Expertise

Specialty and experience covers the whole life cycle of clinical trials from Phase I to IV.

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