Real World Evidence Solutions

Drawing on decades of experience, we offer real-world data solutions for every need: from niche needs identification, justifying access, differentiating value, quantifying an opportunity to demonstrating benefit/risk.

Our work is powered by Real World Data Solutions across the evidence continuum

Outcomes Research & Surveys

Leading studies to identify treatment patterns and patient outcomes, unmet needs as well as burden of illness and resource utilization

Our patient and population-based research has been instrumental in demonstrating the benefit that products and health technologies provide to patients.

Certara studies are trusted by leading innovators to identify treatment patterns and patient outcomes, unmet needs among niche patient groups to target drugs, as well as burden of illness and resource utilization in the real world.

Over the past few years, Patient-Centered Outcomes Research has become increasingly important, allowing patients and their caregivers a voice in assessing the value of healthcare options. Our outcomes research services, including:

  • Burden of Disease Studies
  • Surveys & Health Services Research
  • Patient-Reported Outcomes (PROs) development, adaptation and validation
  • Utility and preferences assessment

Burden of Disease Studies

Certara has in-depth experience in conducting burden of disease studies, both from a patient- and a population- perspective. We combine physician and patient surveys to quantify the burden of illness associated with a specific disease, including estimations of incidence and prevalence, morbidity and mortality outcomes, patient quality of life and also associated economic aspects (e.g. indirect medical costs, non-medical costs…).

Health Services Research

Targeting drugs to patients’ and physicians’ needs, as well as to public health systems, requires understanding treatment pathways, patterns of drug use, and health services utilization. We conduct health services research to inform these decisions, through patient surveys, physician surveys and chart reviews.

Qualitative Research

To appreciate the unmet/uncovered needs of patients, to define the most important needs, the best market access roads and the commonalities and differences between groups, we also use qualitative research methods like focus groups, Delphi panels and semi-structured interviews in addition to surveys. We use CAQDAS programs (“Computer Assisted Qualitative Data Analysis Systems”) to improve the storage, organization, analysis and presentation of qualitative data.

Patient-Reported Outcome & Quality of Life

Formulating a PRO strategy is critical to the development of a product’s value proposition. The added benefit of PROs to the product development strategy is rooted in high quality scales that can address the target audience’s constructs of interest.

  • Development and validation of specific quality of life (QoL) questionnaires
  • Incorporating QoL in pragmatic trials and observational studies
  • Questionnaires based on item response theory
  • Patient satisfaction with medication & patient preferences

We help customers choose the best tools for their needs (HRQoL, satisfaction with treatment, adherence or symptom measures) and troubleshoot any problems or questions related to these instruments. We can perform cultural adaptations of PROs across different countries and design and perform validation studies to assess their psychometric properties (reliability, validity and sensitivity to change). For cases where disease areas lack robust tools, Certara develops new ones that are reliable. We apply Classic Theory, Rasch Model and Item Response Theory in developing and validating PROs. Our team also has experience in developing Computer Adaptive Test based on IRT.

Utility measurement & preferences studies

Interest is growing in developing specific utility measurements that include the range of health states associated with specific diseases. We apply cutting-edge approaches to assess public and patients’ preferences regarding the specific health states of such a measure quantifying the associated utility value. We also perform observational studies to discover patients’ preferences regarding treatment alternatives. This allows patients’ voices to be heard in assessing the value of healthcare options.

Electronic Database Studies

Unmatched quality in data and analysis for various objectives from regulatory to value and access

The Certara team leverages electronic health care databases (EHCD) and electronic Medical Records (EMR) as well as our own data resource PGRx for studies in comparative effectiveness and relative risk, market access studies and bridging-to-real life studies as well as other advanced pharmaco-epidemiological research.

Certara experts pioneered the use of EHCD and EMR for conducting pharmacoepidemiology studies. Our unique services link observational studies to advanced modeling in so-called access data platforms built for bridging-to-real life studies.

Our teams help you assess:

  • Impact of medicines and health technologies on drug and resource utilization
  • Comparative/relative effectiveness of medicines & health technologies
  • Relative risk and continuous benefit-risk of pharmaceuticals

Leveraging Diverse Sources of Data

Our research team delivers the highest scientific rigor in the analysis of real-world data to support research programs such as:

  • Post-authorization efficacy/effectiveness studies (EMA’s PAES & FDA Post marketing commitments)
  • Post-authorization safety studies (EMA’s RMPs & FDA REMS)
  • Continuous benefit-risk assessment
  • HTA dossiers and local submissions
  • Coverage with evidence development
  • Market access evaluations
  • Rapid response to alerts and crisis management

Access to 100 million lives

Reliable, high-quality data that is trusted by regulators and decision-makers

Certara is proud to be the first successful, non-academic applicant to receive access to the new French SNDS  data access of over 50 million lives. We have been partnering with many industry clients to access the new SNDS data. Combined with our own ANSER Real World Data Sets and other databases in Europe, these reliable, high quality datasets offer a combined population of more than 100 million lives in Europe.

Prior to August 2017, only a few data sources were easily accessible in Europe. All were relatively small (approx. 5-7 million) and primary care-based. Since August 2017, France has made the SNDS data (with more than 50 million lives) accessible.