Strong, Comprehensive Medical Affairs and Real-world Outcomes Research Experience

R&D spend for medical affairs research is increasing, indicating the importance of having a better understanding of and evidence for how products will perform in a real-world setting to determine their true market value.

We can collaborate in the design, implementation, analysis and reporting of scientifically robust and innovative research, providing real-world evidence of a product’s safety, effectiveness and economic value.

  • Epidemiology
  • Health economics and outcomes research
  • Observational research
  • Patient, product and disease registries
  • Post-approval safety studies
  • Pragmatic Phase IV trials
  • Patient-reported outcomes
  • Expanded access and compassionate use programs
  • Extended access programs
  • Interventional studies
real world outcomes

Health Economics

Health economic research is conducted to generate evidence of the economic benefit or impact of a health technology in a particular setting to optimise patient access to health technologies. This optimisation is achieved by demonstrating to payers and health technology assessment agencies the economic value of a new product, resulting in optimal formulary placement with a minimum of utilisation restrictions.

The types of economic analyses that might be conducted on a new health technology may be any combination of the following:

  • Budget impact analysis
  • Cost of illness study
  • Cost-efficacy/effectiveness analysis
  • Cost-minimisation analysis
  • Cost-utility analysis

Patient-reported Outcomes

Patient-reported outcomes are a subset of a broader category of assessments — clinical outcomes assessments (COA) — that may be carried out to understand the broad impact of a new health technology.

The four types of COAs are patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures and performance outcome (PerfO) measures.

A PRO is a measurement based on a report that comes from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s report by a clinician or anyone else.

Typical PROs that are generated during a product development program include:

  • Disease-specific, health-related quality of life
  • General health-related quality of life
  • Health utilities measurements
  • Patient preference and/or satisfaction
  • Symptom scores

Epidemiology

GCR takes a collaborative, customised approach to developing epidemiological data, information and knowledge that allow our clients to:

  • Make more informed decisions with greater control of their data
  • Demonstrate their product’s safety, effectiveness and quality with a strong evidence basis
  • Gain the necessary insights to optimise treatment advice and realise their product’s greatest value

The science includes objective clinical outcomes as well as provider- and patient-reported outcomes. While public health experts have traditionally focused on post-approval, population-oriented safety and effectiveness, the biopharmaceutical industry recognises the value of leveraging the science early in the product development process.

GCR’s epidemiology and health outcomes experts are:

  • Engaged in product safety and health outcomes across the product life cycle and risk management continuum
  • Focused on addressing safety and health outcomes holistically and contributing to a product’s comprehensive benefit-risk profile
  • Committed to understanding each client’s unique needs and offering flexible, creative and fully customised study solutions

Unlike interventional studies, which are based on a single design, epidemiologic (observational) studies vary in design and are unique in execution. Because companies are often unsure how to answer critical epidemiologic questions, GCR works closely with clients to first understand their challenges and identify the optimal approach. GCR’s epidemiologists have consulted on the design and successful execution of many types of studies. A partial listing of these studies includes:

  • Case-control studies
  • Chart reviews
  • Comparative effectiveness research (CER)
  • Cross-sectional studies
  • Drug (product) utilisation studies
  • Focus group and key informant interviews (qualitative data)
  • Observational cohort studies
  • Post-authorisation safety studies (PASS)
  • Practice pattern studies
  • Registries (disease, event, product)
  • Risk evaluation and mitigation strategy (REMS) assessments
  • Safety (signal) issue detection and evaluation
  • Secondary database studies
  • Surveillance studies
  • Survey research
  • Systematic reviews and meta-analyses