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

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 medical devices, diagnostics, vaccines, and therapeutics to address unmet needs in cancer, cardiovascular disease, infectious disease, rare disease, and more. His mission is to advance new technologies that save and improve lives and expand access, equity, and value. He does that by helping industry to understand complex landscapes through market research. In 1999, Jonathan co-founded one of the first online medical market research firms, helping to digitally transform that industry. He has served in leadership roles in the US and globally in WPP agencies, including PSB Research, where he formed the healthcare practice and led it for a decade, TNS Healthcare, and Kantar Health (now Cerner Enviza / Oracle). 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 is also a board member of the Brem Foundation to Defeat Breast Cancer and a volunteer mentor to CEOs of start-ups at the Maryland Tech Council.

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 aims to develop and build a validation industry data set, to enable an analysis of the forces impacting the validation industry, validation professionals and organizations mandated to perform validation as a regulated function. State of Validation aims to establish a dataset against which validation professionals may analyze, self identify and benchmark their own validation practices and experiences.  

State of Validation is an annual cross-sectional study, that over time, will enable longitudinal analysis of broader trends, where established, that impact the validation 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

Participants in the 2022 State of Validation study included validation professionals with a wide range of years of experience, job function, seniority/rank, geographic location, industry vertical, organization size and team size. Participants included both primary industry and secondary industry, or those organizations providing equally regulated support services or products to primary industry. All participants’ responses were vetted to ensure they possessed relevant demography, to be included in final results for analysis.  

 

Data
Capture

The capture of both quantitative and qualitative data was facilitated through an online survey, on the basis this method met a range of requirements including question logic, and global distribution. The survey was served to a large number of potential participants via a range of distribution channels, including email and social media, and hosted online on a dedicated survey website.

As an incentive to complete the survey, a small compensation was provided to eligible participants. In order to protect the integrity of the study, compensation (via a gift card) was given only to participants with valid corporate emails. Quality analysis was performed on submissions, and submissions deemed to be invalid were excluded from the sample size.

Email invitations to complete the survey were sent on June 9, June 14, and July 7, 2022, by five different partners. Researchers closed access to the survey on August 16, 2022, after collecting responses from verified participants belonging to the target demographic. The survey was also promoted on partner social media accounts.