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Decision-Makers Agree—Phase I Clinical Research is Becoming More Complex

By March 9th, 2022No Comments

Informing pharmaceutical drug developers, manufacturers, and service providers
Raleigh, N.C. — October 16, 2018 — Industry Standard Research (ISR) announces the release of its newest report, “Phase I Study Trends and Market Outlook (2018-2022),” in which 143 Phase I decision-makers provide valuable insight into market size, factors that could affect the number of studies conducted over the next four years, geographical trends, service provider selection, and desired provider characteristics.

“Phase I research is one of the most dynamic phases of clinical development, as evidenced by eighty-five percent of our respondents agreeing that Phase I studies are becoming more complex. The increasing volume of multi-site studies, which create more workstreams to manage, is one factor that may be contributing to this complexity,” explained Kevin Olson, CEO of Industry Standard Research.

Service providers will find this report useful because it affords them the opportunity to complete self-assessments of their own capabilities, determine what sponsors expect from Phase I trial partners, and enhance their business development strategies based on future market trends.

Given special attention in this report is an analysis of decision-making responsibility during the service provider selection process. Respondents allocated this responsibility across a variety of roles along six key decision junctures for a Phase I study: 1) designing the study, 2) deciding whether to outsource the study, 3) holding the study budget, 4) deciding which CROs to invite to bid, 5) making the final CRO selection, and 6) managing CRO delivery.

Other topics covered include outsourcing proportions, Phase I study spend, Phase I unit ownership, and preferred provider prevalence.  Respondents also shared their viewpoints on emerging trends in the Phase I market such as expansion into developing markets, use of Real-World Evidence, patient centricity, and more. With this report, readers can remain current with market happenings and get a jump on what the market is expected to look like in 2022.

For more information on ISR’s Phase I Study Trends and Market Outlook (2018-2022) report, please visit

About Industry Standard Research

Industry Standard Research is the premier, full-service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR’s off-the-shelf intelligence and custom research offerings, please visit the company’s Web site at, email, or follow ISR on Twitter @ISRreports.