Industry Research

Are Oral Dose Manufacturing Projects Becoming More Complicated?

Has the complexity of oral dose manufacturing projects changed in recent years? Are CDMOs evaluated on the same metrics for simple and complex oral dose manufacturing projects? Data from ISR’s new report provides insight on these questions and more.

Preferred Attributes When Selecting A Phase 2/3 CRO

Many factors come into play during the service provider selection process. One critical factor is undoubtedly the presence of preferred provider agreements.

How Pharma Executives View Future Business Travel

In May Industry Standard Research (ISR) and Life science Leader asked biopharma executives about their travel expectations for the remainder of 2021. Some of that data and personal quotes is presented here.

Preferred Provider Type By Clinical Research Phase

In a recent survey focused on clinical development outsourcing, respondents were asked which provider type they would choose if the choice were completely up to them.

Top Five Clinical Development Outsourcing Costs

In a recent survey focused on clinical development outsourcing, respondents reported that their companies outsourced, on average, 61% of their clinical development activities.

Interest In Hybrid Trials Increases

While outsourcing respondents currently hold mixed opinions on conducting hybrid trials, over two-thirds either currently use or plan to use them in the next two years.

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.

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.

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.