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Five Steps to CDMO Selection

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…
Stephen Baker
August 2, 2022
Articles

Highly Potent API Manufacturing

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…
Stephen Baker
August 1, 2022
Articles

Commercial Bioprocessing Market Outlook

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…
Stephen Baker
June 28, 2022
Articles

Cell & Gene Market Outlook

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…
Stephen Baker
April 7, 2022
Articles

CTMS Benchmarking & Market Dynamics

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…
Stephen Baker
March 18, 2022
Articles

Hybrid Trials Are Here To Stay

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…
Stephen Baker
March 9, 2022
Articles

Warming Up To Hybrid Trials

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…
Stephen Baker
March 3, 2021
Articles

Rare Disease Studies: A Comfortable Patient Is A Retained Patient

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…
Tyler
October 31, 2020
Articles

Small And Emerging Biopharma Companies Outsourcing Practices

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…
Tyler
September 23, 2020
Articles

Provider Selection In Small And Emerging Pharma Companies

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…
Tyler
July 10, 2020
Articles

Can CROs Rise To The Patient Access & Recruitment Challenge?

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…
Tyler
July 6, 2020
Articles

Insights Into The Competitive Clinical Manufacturing Market

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…
Tyler
June 15, 2020
Articles

Fast Track To Flexible Clinical Trials

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…
Tyler
May 7, 2020
Articles

Trends In Clinical Development

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…
Tyler
April 17, 2020
Articles

Outsourcing Success Requires Constant Evolution

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…
Tyler
April 14, 2020
Articles

Sponsor Challenges When Outsourcing Sterile Injectables

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…
Tyler
April 3, 2020
Articles

ISR’s Contract Manufacturing eBook

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…
Tyler
April 1, 2020
Articles

Industry Trends In Clinical Development Technology

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…
Tyler
March 18, 2020
Articles

CRO Market Research

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…
Stephen Baker
March 6, 2020
Articles

6 Reasons You Don’t Use Market Research

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…
Tyler
February 28, 2020
Articles

ISR Projects Growth In eTMF Market

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…
Tyler
January 22, 2020
Articles

Areas Of Growth For Oral-Dose Outsourcing

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…
Tyler
October 1, 2019
Articles

Improving Outsourcing Relationships

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…
Tyler
August 1, 2019
Articles

The Status Of mHealth In Clinical Trials: Trial And Error

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…
Tyler
May 21, 2019
Articles

Influence Of Size In CRO Selection

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…
Tyler
May 1, 2019
Articles

How Will mHealth Benefit Clinical Trials?

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…
Tyler
February 1, 2019
Articles

The Evolving Landscape Of Medical Science Liaisons

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…
Tyler
January 24, 2019
Articles

For CRAs, There’s Less Turnover Than You Might Think

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…
Tyler
January 15, 2019
Articles

New Data And Analysis On Biopharma Capacity

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…
Tyler
January 10, 2019
Articles

Study Startup Technology Investment Pays Off

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…
Tyler
November 27, 2018
Articles

Decision-making Responsibilities When Outsourcing Late-Phase Studies

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…
Tyler
November 7, 2018
Articles

Time To Silence Capacity Alarms For Bioprocessing?

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…
Tyler
September 4, 2018
Articles

Clinical Outsourcing Models: Still A Lot Of Churn And Uncertainty

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…
Tyler
August 20, 2018
Articles

What Makes It So Hard To Select A CMO?

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…
Tyler
August 5, 2018
Articles

CRO Selection Taken Seriously

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…
Tyler
May 2, 2018
Articles

Is CRO Consolidation Good For Pharma?

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…
Stephen Baker
August 15, 2017
Applied Clinical TrialsArticles

Best Practices in Study Feasibility

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…
Stephen Baker
November 8, 2016
Articles

Use Peers’ Experiences To Make Educated CRO Selections

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…
Tyler
May 1, 2016
Articles

When are CMOs used? ISR Reports

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
Stephen Baker
January 27, 2016