Experience

Ecron Acunova

• Germany
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• • Jun 2005 - Present

  Team is led by highly qualified leaders with deep domain experience.We offer complete CDM services on OC platform with service delivery experience of 64 projects in India and more than 200 projects in Europe since 2005. This includes CDISC service for ongoing CDM projects as well as legacy data conversion.Personalised services and flexibility provided with 350 full time professionals, of whom 72 are MDs and PhDs. We have turned the diversity of cultures into synergistic advantages.CDM team qualified in medicine, pharmacy, biotech or IT. Our direct presence in emerging geographies such as India, South East Asia and Central & Eastern Europe provides access to patients, making our services effective and therefore cost-competitive. We have preferred access to 19 teaching hospitals at Manipal University - Asia's largest academic medical centre with more than 1500 physicians treating 1.5 million patients,access to medical experts, statisticians and CDM talent Show less

• • Jun 2005 - Nov 2011

  SOPs ,well defined process as per GCDMP, qualified, experienced and CCDM certified data managers, OC / RDC CDMS platform - qualified as per CSV and compliant to 21 CFR PART 11, experienced Database programmers, TMS with MedDRA and WHO-DDE with ATC level coding, CRF annotation- CDISC compatible/ sponsor specification, automated status reports, non CRF data integration with validation checks, programmatic listings and reconciliation, full dummy extract and database structure finalization, secure data transfers, onsite/offsite study data file archival, well defined project management, adherence to the KPIs, online and offline EDC tool, EDC helpdesk, site training, EDC user manual, SAS programs for various reports and listings, cost optimization on EDC license, database server on UNIX platform, high availability of servers/services, high IBW, well defined DR Plan and data backup plan, CDISC services for ongoing studies and for legacy data conversion. Show less