Data management

Addomed provides full data management services for all types of studies – medicinal products and drugs, medical devices, from routine phase I trials through to large and complex phase III trials, as well as non-interventional studies. Our experienced data management team ensures that the clinical data in your project is collected and managed reliably, efficiently and in compliance with industry standards and regulatory requirements. Addomed data management services offer maximum flexibility for conducting clinical trials with EDC, paper CRFs or a combination of both, on our systems or yours. We are flexible to implement our own data management platforms or sponsor selected platforms while supporting the latest CDISC standards. Regardless of what system is used, Addomeds focus is on the quality and integrity of the data collected.

Our services includes:

  • Development of the Data Management Plan (DMP)
  • Database design
  • Preparation of the Data Validation Plan (Edit check specifications)
  • CRF/eCRF design, Database design
  • Data Entry of CRFs (paper system)
  • Data Review, generate/track/reconcile data queries
  • Provide coding dictionaries for AEs (MedDRA) and medications (WHO Drug) and perform data coding of all AEs and medications
  • Data reconciliation
  • Data transfer specifications
  • Interim analysis
  • Lock database
  • Transfer final datasets to biostatistician