History

  • 2015

    • Metronomia celebrates its 25th anniversary
    • Metronomia implemented the EMA qualified methodology MCP-Mod in three dose finding studies
    • Metronomia becomes member of the BVMA (German Association of Contract Research Organisations)
    • Qualification for Medidata’s RAVE complements our offer in e-clinical trial systems
    • Collaboration with ZIFO Technologies expanded to EDC services
    • Milestone of 500 projects reached
    • Number of 55 employees reached
  • 2014

    • Number of 50 employees reached
    • Involvement in an FDA inspection at a sponsor’s site in September 2014, Metronomia’s eCRF and data management services were part of the inspection, no findings
    • In December Metronomia celebrated the accelerated approval FDA has granted an antibody for the treatment of acute lymphoblastic leukemia. Metronomia has worked with this antibody for more than 15 years and provided data management and statistical services for all clinical studies reported in the BLA.
  • 2013

    • Submission triggered inspection at Metronomia in June 2013 by EMA, BfArM and local authority, no critical finding
    • Participation in BfArM inspection at a sponsor’s site in July 2013, no critical finding
    • Service for eCRF studies significantly expanded by a global 24/ 7 service desk and a greater variety of online- and self-training options
    • Statistical consulting becomes driving force in generating new business
  • 2012

    • New version of Metronomia’s IWRS System released
    • Collaboration with our Indian Partner ZIFO Technologies expanded from SAS macro validation to statistical programming services
  • 2011

    • eCRF / EDC studies became driving force in business development
    • Accelerated business development: Significant number of new customers and increased repeat business
  • 2010

    • Collaboration with Indian CRO ZIFO Technologies established (QC and SAS macro validation services)
  • 2009

    • Number of 47 employees reached, thereof 40 in data management, e-clinical services and biostatistics
    • CDISC Associate Member since August 2009
  • 2008

    • Number of 40 employees reached, thereof 35 in data management, e-clinical services and biostatistics
    • E-clinical services for phase III clinical trials in Singapore, Malaysia and Bulgaria established
  • 2007

    • Routine use of clincase® EDC system
    • E-clinical services for phase III clinical trial in Brazil established
  • 2006

    • First e-clinical trial with clincase® EDC system
    • Two phase III biosimilar studies completed and reported
  • 2003

    • Starting development of online IWRS system for central randomisation and medication logistics
    • DIN EN ISO certification suspended
    • Two phase III studies with a biosimilar drug assigned to Metronomia
  • 2002

    • E-clinical trial with onTrace EDC system
    • Starting development of scanTrace system (online review and retrieval of scanned paper CRFs) and services
  • 1998

    • Strategic decision to implement Clintrial® 4 clinical data management system
    • E-clinical trials with EDC system TRIALink® in Germany and Hungary
  • 1997

    • Establishing Metronomia Network
    • First e-clinical trial with inhouse developed EDC system
  • 1996

    • First e-clinical trial with EDC system from Padcom (later Datatrak)
    • Providing pharmacoeconomic services and establishing Health Economics Research Group (HERG)
    • First oncology study assigned to Metronomia
  • 1995

    • DIN EN ISO 9002 certified
  • 1994

    • First international clinical project assigned to Metronomia
  • 1993

    • Establishing formal co-operation with SSS International Clincial Research GmbH
  • 1991

    • First industry projects started
  • 1990

    • Metronomia was established