Industry Research

The overwhelming majority of small and emerging biopharma companies do not have preferred provider agreements (PPAs) for Phase 2/3 outsourcing. What does this mean?

We asked sponsors who outsource clinical manufacturing to identify which activities they spend the most on.

To better understand the outsourcing practices used by respondents’ companies, ISR asked research participants to provide an estimate for various manufacturing activities.

Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.

What sponsors need from their clinical research partners can shift year to year, which is why ISR asks our respondents about which attributes they believe to be rising in importance when choosing between preferred providers. Below, we share the top three attributes gaining in importance across all clinical phases.

In addition to the role that preferred provider agreements (PPAs) play in the process, companies also seek assistance from specialized outside consultants to help with their outsourcing decisions.

ISR Research took a look at where large vs. nonlarge sponsors differ in terms of openness to emerging trends in clinical development.

ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. We were surprised to see a nearly four-way tie in the results. In this article, we’ll take a closer look at one of these challenges.

Nearly two-thirds of clinical development studies are currently using a software vendor-designed eTMF application. A slight increase (71%) is expected three years from now.

We asked 100 decision-makers in the pharmacovigilance space where in the adoption curve of new technologies they see their organizations with respect to AI in pharmacovigilance.

In a recent study, 4 percent of respondents reported using a sole sourcing model, whereby sponsors select a single central lab for all their testing needs.

ISR recently asked site startup experts about their company’s stance on virtual trials.

ISR asked respondents at sponsor organizations, CROs, and site management organizations (SMOs) about a variety of start-up strategies and how frequently each is employed at their company.

In a recent survey targeting companies that outsource clinical logistics, ISR asked respondents to indicate the proportion of clinical services they have outsourced in the past year and what they estimate the proportion will look like in three years.

While pharma companies, biotechs, and CROs are expanding their use of mHealth technologies, they are not expanding the use of it evenly across all therapeutic areas.

A critical factor when examining service provider selection is the existence of preferred provider agreements. Keeping this in mind, ISR asks respondents to share their selection criteria in a way that demonstrates these agreements’ impacts on the decision-making process.

For companies considering life cycle extension strategies for their oral-dose products, there are clear preferences as to which strategies they would pursue.

ISR research indicates that proactive communication between sponsors and CMOs in these three areas will help to improve outsourcing relationships. Data comes from ISR’s Development and Commercial Outsourcing Models market research report.

As part of our yearly service provider quality benchmarking, Industry Standard Research asks late-phase decision makers to select their top five most important attributes when outsourcing with no preferred providers.

Outsourcing motivations are important considerations to identifying the best outsourcing approach and should influence the type of relationships your organization develops with CMOs. Data comes from ISR’s CMO Quality Benchmarking suite of market research reports and ISR’s Development and Commercial Outsourcing Models market research report.