Flexibility for Global Clinical Programs

Flexibility for Global Clinical Programs

by Melissa

Hello and Welcome!

AccuClin Global provides flexible, quality biostatistical and data management services to support organizations in the conduct of global clinical research programs.   We work closely with our clients to rapidly deploy a full-range of design, set up, programming, validation and reporting services. We highly value accuracy, flexibility and quality in the delivery of our services at every stage of our clients’ projects.

Haibin Shu, Founding Principal

Our Mission

Our passion is to expedite drug approvals by leveraging our successful track record in regulatory submissions.

Accurate Services

We support our clients’ projects with a full-range of biometric services including sophisticated programming capabilities and expert statistical services in all phases of clinical research (Phase I-IV). We also provide relevant business solutions to help our clients optimize the data collection process, analysis and tools.  Altogether, we customize our services to meet our Sponsors’ needs with expert guidance, practical solutions and hands-on execution.   Our major service categories include the following:

  • Data Management process optimization
  • CRF Development
  • Database set up, validation and deployment
  • SAS programming
  • Data management
  • Data review
  • Tables, Listings and Figures (TLF’s)
  • Statistical analysis
  • Analytical tool selection
  • Statistical Analysis Plan (SAP) development
  • Sample size calculations
  • Protocol development
  • Clinical Study Report (CSR) development
  • Regulatory activities
  • Publications

Our Experience

Biostatistics: Ph.D., 15 years of experience working with translational medicine in early phase clinical trials and extensive experience in clinical trials with pharmacokinetic (PK)/pharmacodynamic (PD) outcomes.

Data Management Profile: BN, 4+ years hands-on experience as a Data Manager with a CRO background across multiple therapeutic areas; advanced capabilities in cleaning database including automatic and manual queries; an excellent coder in MedDRA and WHODRUG.

Database Programming: An experienced Clinical Database Programmer since 2002, skilled on EDC platforms including Rave and Oracle RDC; fast turn-around; can work according to Client’s SOPs requirements.

Statistical Programming: Our team has 5-year-experience on average; perform productions of Tables, Listings and Figures for Phases 1 through 4 studies.