Consulting Services

ThesIS provides a full range of thesaurus-related consulting services to complement our coding, versioning, and training offerings.

MedDRA and WHO Drug Implementations
Optimization of Thesaurus Processes and Systems
Review of In-House or CRO-Coded Data
Creation and Maintenance of Company-Specific Coding Conventions
Informatics Consulting and Support

MedDRA and WHO Drug Implementations

ThesIS provides complete MedDRA and WHO Drug implementations for clinical trials and drug safety.

We consult with you on the entire range of issues and considerations, from business processes to computer systems, needed to successfully implement MedDRA and WHO Drug, including:

  • Investigator training
  • Effective CRF design
  • Training on MedDRA and WHO Drug coding and use
  • Optimization of business processes
  • Creation or revision of SOPs
  • Evaluation, modification, and validation of software systems
  • Conversion of legacy data

Our thesaurus experts can help you achieve a successful implementation of MedDRA and WHO Drug with minimal impact to your existing operations.

Optimization of Thesaurus Processes and Systems

ThesIS can evaluate your current thesaurus processes and systems to determine ways to optimize them for effective coding, analysis and reporting.

We root out inefficiencies in your processes and introduce proven techniques that result in the collection of higher quality data and more accurate coding, which in turn results in higher quality analysis and reporting.

Our optimization efforts can lower your costs while improving the quality of your entire thesaurus operations.

Review of In-House or CRO-Coded Data

If your data is being coded by someone other than ThesIS, we can perform a quality assurance review of that coding for accuracy and consistency.

This QA review can be a one-time check, or can be performed on an ongoing basis. We can perform a review of all your coded data, or just a representative sample.

A QA review by our expert coders will ensure that your MedDRA and WHO Drug data is being properly coded. We can pinpoint deficiencies in your coding, and identify instances where your coding conventions may need to be broadened.

Creation and Maintenance of Company-Specific Coding Conventions

Written coding conventions are essential to achieve accurate and consistent coding. ThesIS can create and maintain a set of coding conventions specific to your company.

Your custom coding conventions will be initially based on our "standard" coding conventions, and in the case of MedDRA, on the MedDRA "Points to Consider" document. We then tailor these base conventions to your company's specific circumstances.

We ensure your company-specific coding conventions covers areas such as:

  • Acceptable abbreviations
  • Combination terms
  • Events reported as "Due to"
  • Laboratory results
  • Events reported with a body/site location
  • Events reported with one or more diagnoses
  • Pre-existing medical conditions

In addition, we can regularly update your coding conventions as new versions of dictionaries are released. This ensures that your coding conventions always reflect changes within the latest dictionary versions.

Informatics Consulting and Support

ThesIS provides a full range of informatics consulting and support for your computer software systems. We can:

  • Evaluate and recommend software systems and vendors
  • Assess your existing systems for compatibility with MedDRA and WHO Drug and provide necessary modifications
  • Provide installation, maintenance and support
  • Perform complete validation of new or existing software systems
  • Create custom software systems

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