Services

Seven to One provides two services - Business Process Support and Business Consulting. We support all business domains in the pharmaceutical industry, especially, have demonstrated experience and strength in biostatistics, data management and IT solutions.

Our experienced team provides our clients with full support on-site, solutions for the reduction of business burdens and the improvement of business efficiency. It will be achieved with our flexible and broad range support.

Business Process Support

Our consultants are experts with extensive experience in the pharma industry. We help our clients to greater standardization and improve efficiency. We don't only offer to extract issues and propose solutions, but we also take the responsibility for supporting for execution and producing results. We help our clients meet the best practices in the industry.

Business Consulting

Biostatistics

  • Authoring protocols, SAP, CSR

  • Development of TFL Shells and other statistical analysis specifications

  • Quality management of CRO deliverables

  • Support randomization and unblinding

  • Other documentation support and meeting organization

  • Design and development of company standards (SOPs, guidances, templates, etc.)

  • Implementation of CDISC (ADaM) standards

  • Support in Global process standardization

  • Implementation of ​statistical analysis softwares and macros

Data Management

  • Development of DMP, CRF, EDC specifications

  • EDC development, Edit checks programming

  • Data cleaning, coding, management

  • Other documentation support and meeting organization

  • Design and development of company standards (SOPs, guidances, templates, etc.)

  • Implementation of CDISC (SDTM) standards

  • Support in Global process standardization

  • Implementation of EDC and CDR systems

IT System

  • Development of System roadmaps and RFPs

  • Project management, vendor control

  • Requirement analysis, system design, development and operation design

  • Computerized System Validation (CSV) documentation

  • Other documentation support and meeting organization

  • Design and development of company standards (SOPs, guidances, templates, etc.)

  • System audit support

  • Project management office (PMO)