datametrix AG, Faubourg de l’Hôpital, 3, 2000 Neuchâtel, Switzerland
+41 (0)32 511 4575

Why choose datametrix

Proximity to Collaborate

With offices in Switzerland, USA, European Union, and North Africa, datametrix has means to ensure most effective client support.

Reliability & Expertise to Deliver

A unique set of expertise and experience ensures ability to deliver the project on time and on budget.

Flexibility to Adapt

We demonstrated ability to adapt our proposal , team organization and even the team location to customer needs.

Cost-effectiveness to Compete

Our rationalized management and lean organization allow us to develop cost-effective solution and overcome your budget challenges.

1

Biostatistics and programming

Experienced team of biostatisticians and SAS/R programmers provide you with a whole range of statistical support from design of a smart cost-effective trials till real world evidence data analysis.
  • Study Design and Sample Size Estimation
  • Statistical analysis plans
    • Advanced SAS Programming
    • Responsive, Interactive Statistical Consulting on Demand
  • Statistical reports
  • Interim Analysis planning
  • Statistical programming (SAS® and/or R): Table, Listing and Figures development
  • Data visualization (e.g. to support clinical/medical data review)
  • Resources utilization and pricing (HE&OR)
  • Data mining (exploratory analyses, in particular on registries)
  • Preparation of submission documents (ISS/SCS, ISE/SCE, RMP)

2

Data management and CDISC services

Highly qualified Clinical Data Managers have experience working with DATATRAK, Medidata Rave, Oracle InForm, OC RDC to provide the following services:
  • CRF-Design (e-CRF and p-CRF)
  • Design and database implementation
  • ePro/eDiary systems
  • Data Validation and Query Management
  • Clinical Programming
  • Electronic Data Integration and Transfer
  • Data Management Plan and Data Validation Plan preparation
  • Live database migrations
  • Data conversion and mapping
  • Data Management and systems Audit
CDISC Services is integrated part of clinical data management
  • Creation of related documentation
    • SDTM annotated CRF
    • SDTM metadata
    • DEFINE.PDF
    • DEFINE.XML
  • Creation and documentation related to ADaM
    • Analysis level
    • Dataset level
    • Variable level
    • Parameter level documentation
  • Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and regulatory submissions
  • Creation of documentation for integrated databases
  • Statistical programming using ADaM datasets as input for the production of statistical results

3

Flexible/Functional service provision (FSP)

Datametrix redefine a traditional FSP model by developing an innovative and flexible solution in response to our customer’ needs that offer critical resources that exceed their expectations.The success of Datametrix FSP model is based on deep field expertise, possibility to adapt team size and work load while maintaining high quality and cost-effective services.

Datametrix Adaptive FSP model provides you with:

  • Focused resources:
    • Specialized teams in statistical consultancy, clinical data management, SAS programming, CDISC and medical writing services
  • Multiregional presence and customer support:
    • Easy face-to-face contact with project manager
    • Multiple linguistic expertise to close the language gap
  • Enhanced productivity:
    • Specialized teams
      • Fully trained on customer’s process and SOPs
      • Operational from the first day
      • Experts in their fields: with min 2 years of experience for executives positions and at least 3 month for junior positions
  • Accelerating timelines
    • Only 1-3 months to provide fully operational team of 3-5 people
    • Only 3-5 months to provide fully operational team of 5+ people
  • Improved cost-effectiveness due to:
    • Adaptive work load
    • Reduction of Staff recruitment costs
    • Reduction of day-to day management costs
    • Reduction in Training cost

4

Medical writing

The increasing complexity of clinical trials, regulatory and market access procedures requires an accurate medical writing compliant with the highest ethical and scientific standards. Datametrix medical writing team provide you with a professional support to each stage product life cycle, including product research and development, statistical, medical and marketing activities. We have the unique mix of expertise and scientific knowledge in different therapeutic areas to support our customers in writing various types of scientific, regulatory and marketing documents.

CASE STUDY PORTFOLIO

Customized approach to enhance fast and cost-effective deliverables

Cost–effective deliverables
Cost–effective deliverables