Introduction My name is Brian and I’m the VP of Clinical Operations at a global CRO. My job is to ensure our clinical operations team is prepared to meet the demands of our clients. I am also part of a…
ISR ReportsMarch 30, 2023
Each of the past three years, Industry Standard Research has included questions in its annual CDMO benchmarking research to better understand whether the pandemic has affected drug innovators’ outsourced manufacturing for small molecule drug substance, small molecule drug product, biologic…
ISR ReportsMarch 22, 2023
2023 is the 12th year of Life Science Leader’s annual CDMO Leadership Awards, where contract manufacturers are recognized for their ability to deliver above and beyond the expectations of their drug innovator clients. The awards are the result of sponsor…
ISR ReportsMarch 21, 2023
Introduction My name is Shannon and I’m a VP of R&D at a large pharmaceutical company. My job involves creating a clinical development strategy for the next few years, including managing R&D budgets. Another part of my job is to…
ISR ReportsMarch 17, 2023
Clinical trials often span numerous sites around the globe and continue to implement more and more decentralized elements, such as in-home visits by healthcare providers. Accordingly, the storage and distribution of clinical trial material has become increasingly complex. For example,…
ISR ReportsMarch 2, 2023
In our recent report on clinical trial management systems, CTMS Benchmarking & Market Dynamics (3rd edition), Industry Standard Research explores the evolution of the eClinical market and usage of CTMS in the outsourcing community. Amidst this rapid growth, it can…
ISR ReportsMarch 1, 2023
Interactive response technology (IRT) systems are used to automate supply management, randomization, and analytics for clinical trials. They ensure participants receive the correct treatment at the correct time, allow for enhanced drug supply logistics tracking, and empower users to obtain…
ISR ReportsFebruary 28, 2023
Biologic drug substance developers face an ever-evolving slate of challenges related to CDMO outsourcing. As part of ISR’s CDMO Benchmarking research, respondents are asked to review a list of 28 selection attributes and to identify the one criterion most important…
ISR ReportsFebruary 28, 2023
The Evolution of Outsourcing Over the past few decades there have been considerable changes in the outsourcing environment; at the outset, pharmaceutical companies were primarily offshoring to lower-cost centers and used different contract manufacturers for different projects in a somewhat…
ISR ReportsFebruary 28, 2023
Biopharmaceutical sponsor considerations when selecting a CDMO may include timelines, cost, regulatory requirements, capacity, quality, risks, and previous experience. To help sponsors better understand and prioritize development and manufacturing elements, ISR conducts four annual, manufacturing-specific benchmark studies that ask professionals…
ISR ReportsFebruary 10, 2023
Decentralized clinical trials (DCTs) are studies in which some or all trial-related activities are conducted at a location separate from the investigators’ primary site. DCTs’ numerous benefits include convenience and flexibility for patients, greater opportunities for patient recruitment, increased patient…
ISR ReportsJanuary 27, 2023
ISR consistently seeks to demystify the mystical, and there’s plenty of mystery regarding clinical trial logistics. How do sponsors select a provider? Which activities do they outsource the most? Where are these questions heading? To none other than ISR’s latest…
ISR ReportsDecember 19, 2022
Sponsors will see success in their CDMO partnerships by dedicating time and effort to establish a plan that identifies outsourcing drivers, to select a model that matches company needs and resources, to establish a decision-making process and group, and to…
ISR ReportsAugust 2, 2022
Highly potent API manufacturing is a rapidly growing segment of drug development. Those familiar with HPAPI understand its specialized nature and the strict regulations surrounding it. A complicated and resource-intensive process, sponsors often find themselves in need of knowledgeable outsourcing…
ISR ReportsAugust 1, 2022
Choosing an outsourcing partner for a commercial bioprocessing endeavor carries a gravitas that those outside that endeavor may not appreciate. Equally significant is the challenge facing CMOs in this space, many of whom are competing against larger, well-known manufacturers with…
ISR ReportsJune 28, 2022
I bet you can’t say “cell & gene therapies” three times fast. And by the time you do, you’ll have missed another article on your newsfeed discussing their intricacies and the headaches they can cause. Here’s one from Industry Standard…
ISR ReportsApril 7, 2022
ISR’s CTMS Benchmarking & Market Dynamics (3rd Ed.) aims to tackle clinical trial management systems (CTMS) by helping providers and sponsors alike better understand current trends surrounding this technology and anticipate future ones. This report is the result of primary…
ISR ReportsMarch 18, 2022
Hybrid trials. Decentralized trials. Remote trials. Virtual trials. No matter what you (or anyone else) call them, the rapid uptake of trials in which patients participate from home for some visits/activities rather than exclusively in a clinical setting has been…
ISR ReportsMarch 9, 2022
By Kate Hammeke, VP of Market Research, Industry Standard Research (ISR) @ISRreports For the past six years, Industry Standard Research has asked oral dose outsourcers about the proportions of their projects that are simple, neither simple nor complex, and complex.…
ISR ReportsSeptember 8, 2021
How would you outsource your Phase II/III research needs if you were the only person making the decision? Market Research Director at Industry Standard Research Sherry Hubbard-Bednasz discusses how ISR uses that question to gauge service provider quality and performance.…
TylerJune 16, 2021
Primary market research by ISR Reports is the basis of the awards. Sponsors provide ratings of CROs based on recent outsourced projects. CROs have an opportunity to with these awards in up to three groups of outsourcing respondents – Big…
ISR ReportsJune 7, 2021
Over the past year, the pharma industry has been in overdrive. The best of the best around the world – biochemists, scientists, doctors, researchers, and the like – came together to develop a COVID-19 vaccine in record time. Several vaccines…
ISR ReportsJune 7, 2021
Market Research Director at Industry Standard Research Sherry Hubbard-Bednasz takes a look at the clinical outsourcing models most preferred by outsourcers, and why those models work best for their proponents. “Let’s say you are sponsoring a novel clinical study that…
TylerMay 22, 2021
Vice President of Market Research at Industry Standard Research Rebecca McAvoy analyzes results from a recent study indicating that COVID-19 has made sponsors more willing to run hybrid trials. “In a November 2020 survey, Industry Standard Research (ISR) asked 121…
ISR ReportsMarch 3, 2021
Market Research Director at Industry Standard Research Sherry Hubbard-Bednasz discusses rare disease patient retention. Industry Standard Research recently developed research aimed at understanding the nuances associated with rare disease studies. “Specifically, what does the uphill battle of patient retention look…
TylerOctober 31, 2020
Market Research Manager at Industry Standard Research Patrick Olsen discusses ISR's recent small & emerging biopharma research activities, identifying their specific needs and how they differ from those of larger sponsors. “When looking at the attributes individually, small and emerging…
TylerSeptember 23, 2020
Vice President of Market Research at Industry Standard Research Rebecca McAvoy discusses how the decision-making dynamics at small and emerging biopharma differ from their larger counterparts, and how service providers can leverage those to their advantage. “The lack of PPAs…
TylerJuly 10, 2020
Which clinical research organizations fit your patient recruitment needs? Market Research Director at Industry Standard Research Sherry Hubbard-Bednasz answers how biopharma sponsors pick CRO partners who excel at identifying and recruiting patients for their clinical development programs. “Where do you…
TylerJuly 6, 2020
Vice President of Market Research at Industry Standard Research Kate Hammeke discusses the contributing factors as to why manufacturers of various sizes and capabilities succeed or fail. “A recent ISR study on outsourced clinical manufacturing revealed that respondents use a…
TylerJune 15, 2020
Market Research Director at Industry Standard Research Sherry Hubbard-Bednasz identifies trends taking place in the clinical development industry that indicate a shift to more flexibility during clinical research, especially in light of the COVID-19 crisis. “COVID-19 may have put the…
TylerMay 7, 2020
ISR Reports analyzes company level findings based on 329 sponsor respondents asked to share their thoughts about current trends in the clinical development space. “Agreement with the statement “My organization will run a clinical trial within the next two years…
TylerApril 17, 2020
Vice President of Market Research at Industry Standard Research Kate Hammeke walks through the methodology of the research used to source industry feedback for the 2020 CMO Leadership Awards. She also identifies some of the major differences in industry opinions…
TylerApril 14, 2020
Vice President of Market Research at Industry Standard Research Kate Hammeke reviews the challenges biopharma organizations face when engaging CMOs for sterile injectable drug products. “The explanations provided by respondents who identified a lack of available capacity for small volumes…
TylerApril 3, 2020
It can be difficult to find industry-specific, easy to interpret, trustworthy market data. That’s why ISR Reports created this e-book, chock full of free drug development and manufacturing facts, figures, and expert perspectives. This e-book almost certainly won't answer your…
TylerApril 1, 2020
Market Research Manager at Industry Standard Research Patrick Olsen examines the current trends and challenges regarding clinical development technology in terms of IRB interaction, eCOA/ePRO activities, and eTMF systems. “Per research trends, it’s clear that electronic applications in the clinical…
TylerMarch 18, 2020
In some senses, conducting market research in the CRO industry is no different than research in any other industry. We use most of the same methodologies, including surveys, focus groups, interviews, etc. Many of the analytical approaches apply across industries…
ISR ReportsMarch 6, 2020
How do you ensure the research products and services you buy will make you confident in the decisions you make? Here are six reasons why Industry Standard Research ensures you are getting the value you should expect from quality market…
ISR ReportsMarch 3, 2020
How to be sure market research isn't necessary The CEO of Industry Standard Research Kevin Olson talks through the reasons why you may not be considering market research as a necessary gut check for your next project. “This article explores…
TylerFebruary 28, 2020
How Pharma, CROs, and CDMOs can prepare for 2020 ISR conducted approximately two dozen individual pieces of market research for syndication in 2019. This webinar summarizes many of the important learnings from these projects, providing attendees with real, usable data…
TylerFebruary 11, 2020
President of Industry Standard Research Andrew Schafer discusses eTMF adoption, usage, and other findings from ISR's recent eTMF report. “One of the interesting findings is regarding the awareness of eTMF providers. When ISR first released our eTMF report back in…
TylerJanuary 22, 2020
Vice President of Market Research at Industry Standard Research Rebecca McAvoy shares best practices from site start up experts that mitigate the challenges associated with site contract and budget negotiations. “When ISR recently asked respondents taking a survey on site…
TylerJanuary 13, 2020
President of Industry Standard Research Andrew Schafer explains why the time may be right for PPD to re-enter the public market. “You have some big firms in there," he said, referring to the sector. "Probably one of the reasons for…
TylerDecember 6, 2019
ISR reviewed findings from two recent, high-profile pieces of market research in our October 29th webinar. One details the performance of specific IRBs in the clinical development space across such metrics as timeliness and responsiveness of protocol review and local…
TylerOctober 29, 2019
President of Industry Standard Research Andrew Schafer talks with Life Science Leader about the state of the CRO market, and why it has seen continued growth even as the S&P 500 fell by 6% in 2018. Most of this growth…
TylerOctober 14, 2019
Outsourcing growth is predicted across all sponsor groups Vice President of Market Research at Industry Standard Research Kate Hammeke discusses outsourcing trends from the results of a recent oral dosage survey with Life Science Leader. In fact, across all sponsor…
TylerOctober 1, 2019
Vice President of Market Research at Industry Standard Research Kate Hammeke talks with Life Science Leader about the practices that can improve communication and trust between sponsors and CMOs. Sharing information doesn’t always come naturally in outsourcing relationships. This may…
TylerAugust 1, 2019
Vice President of Market Research at Industry Standard Research Kate Hammeke explains why outsourcers should focus on the reasons their company is outsourcing before considering selection criteria or specific companies. From Life Science Leader: Let’s say your organization has internal…
TylerMay 31, 2019
President of Industry Standard Research Andrew Schafer speaks with Clinical Leader about how larger companies are forging ahead with mHealth implementations, but barriers are still preventing others from investing in mHealth use. "Trial-and-error” is how I would describe the current…
TylerMay 21, 2019
Vice President of Market Research at Industry Standard Research Rebecca McAvoy discusses whether the company size of a CRO has an impact on its therapeutic expertise, and by extension, an impact on outsourcing selection. CRO selection. Whether you’ve been in…
TylerMay 1, 2019
PPAs are used by the majority of outsourcers Vice President of Market Research at Industry Standard Research Kate Hammeke discusses preferred provider agreements with Life Science Leader, detailing why they're so popular with innovators. At the same time, ISR has…
TylerApril 1, 2019
Andrew Schafer (moderator), Kevin Olson, (interviewer) and Kate Hammeke (subject expert) from Industry Standard Research share data and insights from our CDMO Quality Benchmarking reports that will help CDMOs to better understand how to move their position in the competitive…
TylerMarch 14, 2019
Use outsourcer insights to select a CMO Vice President of Market Research at Industry Standard Research Kate Hammeke speaks with Life Science Leader about the CMO selection criteria deemed most important by experienced outsourcers. Similarly, when sponsors are outsourcing small…
TylerMarch 1, 2019
VP of Market Research at Industry Standard Research Kate Hammeke discusses how mHealth technologies are currently used in clinical trials, and why they could possibly make a larger impact in the near future. The mHealth experts with whom ISR spoke…
TylerFebruary 1, 2019
CEO of Industry Standard Research Kevin Olson describes how marketers can take control of the ways in which they are evaluated. Services marketers are often not evaluated on actual marketing performance. The lack of objective and relevant performance measures can…
ISR ReportsJanuary 29, 2019
Editor Anna Rose Welch at Biosimilar Development discusses the role MSLs play in the pharma industry, and how it will evolve. Quite often in this industry, we refer to education as a singular initiative put together by one organization or…
TylerJanuary 24, 2019
Editor Ed Miseta at Clinical Leader discusses CRA compensation and the CRA/RBM relationship. In 2015, risk-based monitoring (RBM) was making waves. That year Industry Standard Research (ISR) published an infographic which stated, “Increasingly sophisticated EDC capabilities, declining R&D productivity, and…
TylerJanuary 15, 2019
Chief Editor Louis Garguilo at Outsourced Pharma speaks with Industry Standard Research VP Kate Hammeke about how the newly released Biologic API Contract Manufacturer Quality Benchmarking (4th Edition) data bear on the concern about bioprocessing capacity shortage. Among the…
TylerJanuary 10, 2019
CEO of Industry Standard Research Kevin Olson explains how marketers can elevate their credibility, the credibility of their strategy, and the overall impact of marketing plans in their organization. Is your services marketing strategy constantly being questioned, critiqued, and…
TylerDecember 12, 2018
Chief Editor Ed Miseta at Clinical Leader speaks with Industry Standard Research President Andrew Schafer about ISR's custom research report eClinical Technology Adoption and Challenges in Study Startup. My advice, based on the data we collected, would be to make sure…
TylerNovember 27, 2018
VP of Market Research at Industry Standard Research Kate Hammeke explains the importance of conducting decision-making process research for sales and marketing outreach. Market research categorized as DMP/DMU (decision-making process/decisionmaking unit) studies may be conducted qualitatively, via in-depth interview, or…
TylerNovember 7, 2018
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…
TylerOctober 16, 2018
Small Molecule Market Trends Extend to Biologics Editor Anna Rose Welch at Biosimilar Development speaks to VP of Industry Standard Research Kate Hammeke about our recent report Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition). Indeed, there are already…
TylerOctober 10, 2018
Chief Editor Louis Garguilo at Outsourced Pharma speaks with VP of Industry Standard Research Kate Hammeke about the non-appearance of a long-anticipated capacity crunch for bioprocessing services. One thing is certain: When considering overall outsourcing capacity, there are mitigating factors…
TylerSeptember 4, 2018
What does the ideal bioprocessing CMO look like? VP of Market Research at Industry Standard Research Kate Hammeke reviews some interesting findings which arose from comparing a theoretical question's responses to other survey results. The five most common answers to this unaided…
TylerSeptember 3, 2018
Many have not found a clinical development outsourcing model that works Chief Editor Ed Miseta at Biosimilar Development discusses ISR's recent report Clinical Development Outsourcing Models (3rd Edition) with President of Industry Standard Research Andrew Schafer. Being the third edition of…
TylerAugust 20, 2018
VP of Market Research at Industry Standard Research Kate Hammeke answers why sponsors regularly struggle with CMO selection as one of the most difficult parts of their outsourcing manufacturing activities. In it we asked participants an open-ended question: “In…
TylerAugust 5, 2018
VP of Market Research at Industry Standard Research Rebecca McAvoy explains why sponsors need to give an appropriate amount of attention toward choosing their service providers. The remaining 35 percent at least slightly disagreed with the statement, meaning they anticipate some level…
TylerMay 2, 2018
Measuring where in the purchase process manufacturers win and lose customers VP of Market Research at Industry Standard Research Kate Hammeke explains how important it is to know your business’ competitive landscape and how that impacts your buying audience, and…
TylerMay 2, 2018
VP of Market Research at Industry Standard Research Kate Hammeke discusses how both sponsors and CMOs can improve their understanding of the link between selection priorities and performance strengths, and how aligning these attributes can impact the client-vendor relationship. It’s…
TylerApril 7, 2018
Chief Editor Louis Garguilo at Outsourced Pharma asks "Are there strategic and tactical differences for programs when outsourcing to CMOs?" In the small molecule report (SMR), 70% of biopharma companies that use “preferred provider lists” responded that 1 to…
TylerMarch 2, 2018
CEO of Industry Standard Research Kevin Olson offers three tips to strengthen your selection process with third-party performance benchmarking. Selecting a CMO or CRO is stressful, expensive, and time-consuming. The complexity of these supplier organizations makes them difficult to…
TylerFebruary 2, 2018
Big CROs get bigger—how will that affect sponsors? Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs…
ISR ReportsAugust 15, 2017
Vice President of Market Research at Industry Standard Research Rebecca McAvoy explains how our experiential user data can be used to pick the best service provider for your unique needs. From Life Science Leader: For decision makers whose companies have…
TylerMay 9, 2017
VP of Market Research at Industry Standard Research Kate Hammeke discusses how greater diversity in selection criteria leads to a cloudy decision-making process because no specific criterion dominates the CMO selection decision. To help Life Science Leader’s readers understand…
TylerApril 8, 2017
Outsourcers know what they want, do they know your CDMO provides it? A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report.…
ISR ReportsFebruary 20, 2017
Only one-third of manufacturing is currently conducted in-house, from development stages to after commercial launch, according a recent report. The report, published by Industry Standard Research (ISR), explained that the majority of work is outsourced – and mainly to preferred…
ISR ReportsNovember 18, 2016
Successfully navigating the medical, clinical, logistical and regulatory challenges associated with establishing the feasibility of a clinical trial is not easy. Insights from sponsor organizations, CROs and sites have been compiled in ISR’s Best Practices in Study Feasibility report. A…
ISR ReportsNovember 8, 2016
The adoption of eTMF solutions is accelerating – with more than 50% of investigative sites expected to have access to a sponsor/CRO eTMF application within three years. This figure is according to a recent report published by Industry Standard Research…
ISR ReportsOctober 27, 2016
Director of Market Research at Industry Standard Research Rebecca McAvoy discusses with Life Science Leader about how you can use data from other decision-makers to have confidence in your own outsourcing decisions. Having access to performance data from CROs’ users…
TylerMay 1, 2016
Director of Market Research at Industry Standard Research Kate Hammeke explains why experiential data is more important to CMOs and Sponsors than perception-based data when determining service provider quality. The change from perception-based data to experiential data is important…
TylerApril 2, 2016
2015 proves the CRO market's growth holds strong through a sell-off year You often hear that this is a good time to be in the pharma industry. I think that is especially true of the clinical trial sector. Despite…
ISR ReportsMarch 1, 2016
While CMOs are currently engaged mainly through tactical outsourcing, this paradigm will shift as more companies begin outsourcing to preferred providers, says ISR report. https://www.outsourcing-pharma.com/Contract-Manufacturing/When-are-CMOs-used-ISR-reports
ISR ReportsJanuary 27, 2016
