Case Studies

Research Compliance

The Problem

Client operates in many markets around the world with a complex set of regulatory requirements that vary by geography. Manually checking each project for compliance slows down research projects and puts new product development on hold at critical junctions.

Client Objectives:

  1. Raise adherence to high standards of compliance by having all market research projects go through a consistent, managed compliance process
  2. Avoid unnecessary legal and financial risks by having a higher level of compliance; the financial risks of non-compliance are potentially hundreds of millions of dollars
  3. Produce an audit record of compliance activities on any project and in total
  4. Back up compliance staff by a decision support system specifically configured to their needs
  5. Operate more market research projects with less compliance professional labor over time
  6. Explicitly support a vetted and robust set of regulatory rules that apply to each country around the world for market research projects and that is updated as rules change
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Without Northern Light’s Compliance Engine there is no way we could track our compliance performance across the thirteen countries, 1500 projects and 10,000 market research documents we generate every year.”

Global Head of Market Research

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What Northern Light does:

Northern Light created a Compliance Engine configured with the compliance rules reflecting the compliance requirements of each of the important countries in the world that the client conducts research in, which enables:

  • Research project leads to answer compliance related questions
  • The question tree to branch based on answers to questions — for example, if the research project lead identifies France as a country, a question about showing competitor marketing materials to respondents is asked (which is illegal in France), but if France is not identified, this question may be skipped
  • Answers to questions to be compared to the rules and immediate feedback presented to the research project lead — for example, the research project lead that answers “yes” the research is in France and “yes” marketing materials of competitors will be shown to respondents is immediately advised that this research project does not meet regulatory standards
  • Generation of a Compliance Plan document in a PDF format that specifies the compliance steps and approvals required for the project — for example, if a research project involves the potential identification of adverse events, then the Compliance Plan may specify that Pharmacovigilance must sign off on the plan and receive a copy of all results

Results:

  • The Compliance Plan document to be uploaded by the research project lead into Primary Research Manager and become a document in the project document kit
  • The Compliance Plan to be added automatically by Northern Light to Client OneSearch if this is desired
  • The Compliance Plan to be a carried out in the project management tool, and made available for the client research management and compliance team to review against the actions of the research project lead
  • Project documents to be imported, and analytics and machine learning applied to them, to identify compliance risks and issues in the research reports themselves
  • A detailed log of all Compliance Plans and Document Analyses to be kept for compliance audit purposes in easy to export formats
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