Overview

Our integrated approach is unique as it spans the product life-cycle following a roadmap which corresponds to the changing environment of drug regulation and reimbursement.

Our strength is to plan and provide a seamless blend of pre- and post-approval real-world data in order to optimize product approval and reimbursement. The sooner you plan and generate the evidence, the sooner you will be able to demonstrate product value.

 

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CASE STUDY – PHARMACOVIGILANCE

Following a pharmacovigilance inspection, we were instructed to implement a process for signal detection.  What can be done for small- to medium-size companies or locally in a country?

  • Based on the number and types of products in the company’s safety database, we have developed valid and semi-automated signal detection system.
  • We also have developed pharmacovigilance tools in healthcare databases using, e.g. the OMOP environment.

 

CASE STUDY – THERAPEUTIC RISK MANAGEMENT

Based on the potential and identified risks of a product is risk minimization beyond labeling required?  If so, which tool should be used for the minimization or mitigation of this or these risk(s)? 

  • Review of clinical safety data
  • Assessment of target population and epidemiologic country-specific data
  • Systematic review and meta-analysis
  • Background rates
  • Failure mode and effect analysis

 

CASE STUDY – STUDY CONDUCT

At the time of product launch, products are often not reimbursed, hence are not in administrative claims databases. What should I do to evaluate the effectiveness of my risk minimization intervention?

Evaluation of implementation and/or efficacy of RMI are often done via:

  • Failure mode and effect analysis
  • Knowledge and understanding surveys using appropriate sampling strategies and sampling fractions, repeated over time to allow for the changes of the populations of prescribers and patients over the first two years post-market
    • National surveys of physicians
    • Web-based
  • Drug utilization studies using retrospective cohorts with ad hoc data collection.  Retrospective studies are desirable in order to avoid influencing prescribing and monitoring behaviours.

 

CASE STUDY – STRATEGY CONSULTANCY

What type of study should be conducted to assess value differentiation of our product?

  • Study design and outcomes
  • Benefit-risk assessment
  • Database mapping
  • Liaison between sponsor and database custodians for data access and study conduct