Industry Research

Attributes Gaining Importance When Selecting Among Preferred Providers For Phase 1 Services

The service provider selection process is a complicated one. Many factors come into play during this process. One critical factor is undoubtedly the presence of preferred provider agreements. Companies can spend a great deal of time negotiating these agreements, and their presence, or lack thereof, can make or break which CROs are shortlisted or awarded a Phase 1 study.

Clinical Manufacturing Market Outlook

In ISR’s Clinical Manufacturing Market Outlook report, we asked sponsors about their top reasons for being satisfied with an outsourced clinical trial manufacturing project.

Decentralized Clinical Trial Predicted Use

Though not all respondents to ISR’s Decentralized Clinical Trials Market Outlook reported a smooth experience, nearly 60% came away with a positive overall impression of DCTs.

COVID Continues To Impact Outsourced Manufacturing And Supply Chain Security

ISR shares results from its annual benchmarking surveys on how the COVID-19 pandemic has impacted outsourced manufacturing over the past three years as well as how drug innovators plan to reduce risk and improve supply chain security going forward.

How Well Are CDMOs Performing On Sponsors’ Most Important CDMO Selection Criteria?

Focusing on the 20 common CDMO attributes that serve as both selection drivers and also performance metrics, ISR compared how well contract manufacturers are performing on the criteria that matter the most among sponsors.

Clinical Manufacturing Volume By Service Provider Category

When it comes to outsourced clinical manufacturing, respondents allocate the largest proportion of project volume to a combination of drug substance and drug product CDMOs.

Phase 1 Study Complexity

ISR recently ran a survey to assess dynamics in the Phase 1 clinical development space. Over 80% of respondents believe Phase 1 studies are getting more complex.

The Top Reasons Bioprocessing CDMOs Lose Bids

Respondents continue to report that service providers primarily lose bids for bioprocessing efforts due to regulatory violations/FDA form 483 warnings, their inability to meet required timelines, and high cost.

Preferred Provider Agreements At Small & Emerging Sponsors

While preferred provider agreements are an important piece of the provider-selection puzzle in many parts of clinical development, this is not necessarily the case among small sponsors.

Outsourced Proportion Of Phase 2/3 Spend

ISR recently ran a survey to assess dynamics in the Phase 2/3 clinical development space. Survey respondents reported that, on average, two-thirds of their company’s spend on Phase 2/3 studies over the past year was outsourced.

Where Bioprocessing Outsourcers Stand On Capacity Concerns

Insights into bioprocessing outsourcers’ level of concern regarding current and upcoming available capacity, whether they are currently facing limits, and what they plan to do about a potential shortage.

Volume Of Trials With Outsourced Clinical Logistics

ISR’s Clinical Logistics Market Dynamics report provides details on drug developers’ use of the various types of service providers available for outsourced clinical logistics.

Outsourcers Who Most Heavily Rely On CDMOs Often Lack CDMO Selection Resources

The 2022 iteration of ISR’s CDMO Outsourcing Models report relays similarities and differences in how outsourcing decisions are made at drug innovator companies of various sizes.

Predicted Changes In Outsourcing Rates For Highly Potent API

ISR’s latest research on highly potent API manufacturing asks participants whether they expect any change to the proportion of highly potent molecules in their portfolios, as well as any change to their outsourcing rate for high-containment manufacturing.

Phase 2/3 Service Provider Attributes Gaining In Selection Importance

In ISR’s recent CRO Benchmarking study, outsourcers of Phase 2/3 clinical development services were asked to identify attributes that have been rising in importance as CRO selection criteria over the past 12 months.

Preferred Provider Agreements For Phase 1 Services

Forty-two percent of respondents indicated their company has formal agreements in place, but there is a notable difference in preferred provider agreement (PPA) use when viewed through the lens of company size.

Outsourcers Send A Consistent Message In Phase 2/3 CRO Selection

Through two online surveys, one focused on the Phase 1 space and another focused on the Phase 2/3 space, recent customers have evaluated the performance of 50 CROs across 20+ attributes.

Outsourcing Differences By Company Size — Biologic Drug Substance Manufacturing

ISR split the data from its most recent Biologic API CDMO Benchmarking report by large and non-large respondents to highlight the differences in outsourcing preferences and practices.

Biologic And Small Molecule Drug Substance CDMO Selection Metrics Align

ISR’s annual CDMO Benchmarking research asks participants to identify the CDMO attributes that factor into their service provider selection decision.

Drug Product CDMO Selection Metrics Point Toward Pandemic-Induced Concern

ISR’s annual CDMO Benchmarking research asks participants to identify the CDMO attributes that factor into their service-provider selection decisions.