Author and methodology

Research

Independently authored by a leading Academic Researcher, State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with validation professionals around the world.  

About the Author

2024 Author

Jonathan Kay

Jonathan Kay is a trusted advisor to life sciences and digital health companies. Jonathan has supported the successful development, launch, and commercialization of dozens of biotech and pharmaceutical therapies, medical devices, diagnostics, and vaccines to address unmet needs in cancer, cardiovascular disease, infectious disease, rare disease, and more. He founded the consultancy Health Market Experts, LLC, with a mission to advance new technologies that save and improve lives and expand access, equity, and value. He does that by helping clients understand complex landscapes through market research and market strategy.

In 1999, Jonathan co-founded one of the first online medical market research firms, helping to digitally transform that industry. That firm was acquired by the Interpublic Group. Subsequently, he served in leadership roles in the US and globally in WPP agencies, including Kantar Health (now Oracle Life Sciences).

Jonathan earned a B.A. from Cornell and a Master in Public Policy from the Harvard Kennedy School of Government. He is fascinated by the application of artificial intelligence to healthcare and completed studies of “Artificial Intelligence: Implications for Business Strategy” at MIT. Jonathan advises CEOs of start-ups and senior management in Fortune 100 companies.

Study design

Methodology

State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with validation professionals around the world.  

Objective and Study Type

State of Validation develops a comprehensive industry data set to analyze the forces impacting the validation industry, its professionals, and organizations required to perform validation as a regulated function. This data set allows validation professionals to analyze, self-identify, and benchmark their own practices and experiences against industry standards.

State of Validation is an annual cross-sectional study. Over time, this study will enable longitudinal analysis of broader trends that impact the validation industry. Through consistent yearly analysis, it aims to establish and track these trends, providing valuable insights for the industry.

Participant Demography and Limitations

State of Validation’s target populace is any professional currently employed in any validation, quality, or compliance function, under which compliance to the following principles, guidelines and regulations are required:  

  • ALCOA++
  • International Council for Harmonization (ICH)
  • FDA 21 CFR parts 11, 210, and 211
  • EU GMP Annex 11 and 15
  • GAMP 5

Participants in theState of Validation study include validation professionals with a wide range of years of experience, job function, seniority/rank, geographic location, industry vertical, organization size, and team size. Participants include both professionals engaged directly in validation or those organizations providing equally regulated support services or products to relevant industries. All participants’ responses are vetted for relevancy.

Data
Capture

The capture of data is facilitated through an online survey, globally distributed and tested for question logic. The survey is served to many potential participants via a range of distribution channels, including email, in-person events, and hosted online on a dedicated survey website.

 

As an incentive to complete the survey, a small gift card is provided to eligible participants as compensation. To protect the integrity of the study, compensation is given only to participants with valid corporate email addresses. Quality analysis is performed on submissions. Submissions deemed to be invalid are excluded from the sample size.