Clinical Data Management

A clean database for the statistical analysis and submission to regulatory authorities is one of the crucial aspects of a clinical trial. SPARC Consulting offers different software solutions for data collection, cleaning and reporting by always applying fully validated systems and providing clean scientific data in compliance with regulatory requirements. The choice of the tool is based on the complexity of the study and on the client's requirements. To ensure a high quality level and the integrity of clinical we work closely with the sponsor to define the project's needs and apply established standard operating procedures.

SPARC Consulting has a back-up and a disaster recovery system to ensure that all data remain confidential and safe.

Our data management services include:

  • CRF design, printing and annotation (conventional, CDASH, or SDTM compliance)
  • Database design and study setup
  • Data entry
  • Remote data capture (eCRF)
  • Data validation and query resolution
  • Clinical coding using MedDRA and WHO-DD dictionaries or client specific dictionary
  • Serious adverse events reconciliation
  • Laboratory data handling
  • Database transfers (conventional and STDM formats)
  • CDISC database conversions
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Site last updated: Tuesday 06 May 2014, 13:31
SPARC Consulting Srl - Via Archimede 94 - 20129 Milano
Tel. (+39) 02 43119667 - Fax (+39) 02 87071294 - info@sparcconsulting.com
P.iva/C.F./Numero iscrizione Registro delle Imprese di Milano: 07616020967 - REA: MI-1971208 - Capitale sociale: 27.000 euro I.V.
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