Services

Coding Tools

The FDA has adopted the MedDRA dictionary for coding the adverse event data stored in the FDA adverse events reporting system database and Manufactures are encouraged to comply with the FDA requirements. In the next years, all expedited (serious) adverse drug reaction reports will be submitted electronically to major global regulatory agencies (FDA, EMEA, MHW), using MedDRA terminology. MedDRA is the language of communication among pharmaceutical manufactures, regulators and contract research organizations (CROs).

Pharmadhoc provides Coding support services for Pharmaceutical Industry, biotechnology companies, contract research organizations (CROs), and scientific and/or clinical research groups.

The services include:

• Assistance with:

  • MedDRA implementation
  • MedDRA use, coding outsourcing, on-site coding, and legacy data conversion
  • manual reclassifications
  • establishing of a conceptual synonym table
  • dictionaries management


• Auto-coding algorithm implementation

• Development of coding guidelines

• Coding Consulting:

• Coding and dictionary training for coders, data managers, Clinical Investigators, study coordinators, CRAs, information technology specialists, and other members associated with the implementation and maintenance of coding dictionaries.

• Reviewing codes and ensuring coding consistency

• Assistance on improving coding tools

• ATC codes validation

• Creation of an advanced conceptual mapping techniques for NCI CTC terms

• Quality Control

For more information about Pharmadhoc and its services, please feel free to contact M. Azzouzi at +33 (0)8 71 76 88 17,
or send an email to Pharmadhoc