Industry Research

Insights On How Outsourcing Decisions Are Made

How does your company’s approach to making outsourcing decisions compare with others in the industry? Data from ISR’s CDMO outsourcing models report highlights common practices that, when adopted, may improve outsourcing outcomes from drug innovators’ perspectives.

Outsourcing Drivers For Small Molecule Manufacturing

ISR’s recent survey of small molecule outsourcers found that the majority of respondents outsource for one of two reasons: for all of their manufacturing needs, or to augment their internal manufacturing capacity.

Sources For Clinical Outcome Reporting And Assessments

In a recent survey of respondents familiar with eCOA and ePRO systems, ISR asked about respondents’ past and projected use patterns regarding both the source of clinical reported outcomes and the source of clinical outcomes assessments (COAs).

CMOs Continue To Exceed Sponsor Expectations

ISR explains how the CMO Leadership Awards and the corresponding market research data can be used to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

Number Of EDC Systems Used — Current And Projected

In our most recent survey of EDC users, respondents indicated they are currently using 2.4 EDC systems on average to conduct their companies’ clinical trials.

Sponsor Interest In Current Phase 1 Trends

We asked respondents their level of agreement regarding several trends in the Phase 1 space to assess the direction in which their organization’s interest is heading.

Phase 2/3 Outsourced Spend By Provider Type

ISR asked respondents responsible for outsourcing Phase 2/3 drug development how they allocate their outsourcing budget toward CROs of various sizes and academic medical centers.

Top 5 Challenges In Finding Rare Disease Patients

ISR asked respondents with involvement in patient recruitment and retention activities for Phase 2/3 rare disease studies about their pain points regarding patient recruitment.

PPA Differences Between Small And Large Sponsors

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?

Manufacturing Expenditure By Activity

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

Trends In Bioprocessing CDMO Selection

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.

Small & Emerging Outsourced Manufacturing Activities

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

Attributes Gaining Importance In Clinical Research

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.

Use Of Outside Consultants In Phase 2/3 Clinical Research

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.

Technology In Clinical Trials: Differences By Company Size

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

Sponsor Challenges When Outsourcing Sterile Injectables

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.

Use Of TMF Solutions In Clinical Development Studies

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.

Pharmacovigilance Technology And The Adoption Of AI

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.

Sole Sourcing Arrangements For Central Labs

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.

Stances On Implementing Virtual Trials

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