Archive - Industry Standard Research

Technologies & Capabilities in Demand for Oral Dosage Forms Manufacturing

Outsourced Manufacturing for Oral Dosage Forms From the commonly available tablets and capsules to more specialized forms like bi-layer and chewables, oral dosage forms remain the most popular drug products on the market. In this highly competitive and flourishing landscape,…

Brandon Allison

Gene Therapy Timelines & CDMO Selection Attributes

Manufacturing

Gene Therapy CDMO Timelines & Selection Attributes

The Long Road to Approval for Gene Therapies We’ve come a long way from the first gene therapy clinical trial in 1990, but for all the hurdles overcome and advancements made, timelines remain one of the most prominent pain points…

Brandon Allison

Clinical Trials

Five Steps to CRO Selection

Sponsors can facilitate successful CRO partnerships by clearly defining the goals of the clinical trial, choosing an outsourcing model that considers project needs and internal capabilities/resources appropriately, communicating consistently and effectively during the decision-making process, and informing provider selection with…

Brandon Allison

Manufacturing

Exploring the Integral Role of CMC in Small and Emerging Biopharma

The Chemistry, Manufacturing, and Controls Function In the dynamic world of biopharmaceuticals, small and emerging companies play a vital role in driving innovation and advancing groundbreaking therapies. While these companies often possess cutting-edge science and promising drug candidates, they may…

Laura McWhinney

Manufacturing

Biopharma Outsourcing Trends for Sterile Injectable Manufacturing

Evolving Perceptions and Practices in Sterile Injectable Outsourcing Sterile injectable medicines provide significant advantages in terms of rapid and accurate drug delivery. Many newer medications cannot be produced as an oral dosage form for various reasons, making injectable delivery an…

Brandon Allison

Manufacturing

Cell & Gene Therapies Outsourcing Trends

The Growing Cell & Gene Market The outsourced cell and gene manufacturing space has experienced notable expansion and change in recent years. As the advancement of cell and gene therapies continues, drug innovator companies have come to rely heavily on…

Brandon Allison

Clinical Trials

Benefits and Drawbacks of Clinical Development Outsourcing Strategies

Perspectives on Clinical Development Outsourcing Outsourcing plays a vital role in the clinical development programs of biopharmaceutical companies, offering increased flexibility; access to external expertise and technological advancements; and improved efficiency. Our research on clinical development outsourcing models provides valuable…

Jenn Holloway

Articles Clinical Trials Manufacturing

Performance Benchmarking Informs Service Provider Selection

Selecting a CMO or CRO is stressful, expensive, and time-consuming. The complexity of these supplier organizations makes them difficult to evaluate. Far too often, decision makers lack vital information to support selection decisions. But the consequences of selecting the wrong…

Kevin Olson

Articles Custom Research

How Services Marketers Can Own Their Performance Measures

Services marketers are often not evaluated on actual marketing performance. The lack of objective and relevant performance measures can limit respect for the marketing function and influence within the organization, and that’s problematic. Instead, services marketers are often evaluated on…

Kevin Olson

Articles Custom Research

How Services Marketers Can Build a Strong Marketing Strategy

Is your services marketing strategy constantly being questioned, critiqued, and disrupted internally? Too often, marketers lack vital information to create an effective marketing strategy and your organization and department suffer due to constant disruption of marketing plans. You, as a…

Kevin Olson

Articles Custom Research

The Importance of Market Research & Why You Don’t Use It

Let’s set the scene: You’ve got a project. It’s probably not the most important thing you or your company will do this year but it’s meaningful. There’s a real chance to move the needle with this one. Maybe you’re considering…

Kevin Olson

Brand Health

How Custom Brand Studies Can Help Your Company Succeed

In the fiercely competitive world of biopharmaceuticals, standing out from the crowd is essential. That’s where Industry Standard Research’s brand position market research comes into play, offering companies the key to standing out … in the good way. Understanding your…

Laura McWhinney

Clinical Trials

Can’t Stop Us Now: CRO Growth Amid Uncertainty

The world is flush with economic uncertainty, so this may come as a surprise: the CRO market has been experiencing steady growth. Even with a global pandemic, this growth trend is expected to continue. (See our just-published report 2023 CRO…

Laura McWhinney

Clinical Trials Technology

Advancing Clinical Research with Advanced Technology

Technology advances so rapidly, it seems that adapting to innovative technology takes more time than it does to actually develop the technology. It was fewer than thirty years ago that we first heard those grating sounds of dial-up internet, connecting…

Laura McWhinney

Clinical Trials

Win the Small and Emerging Sponsors’ Service Contracts

Requests for proposals have been well-established and can help sponsors evaluate service providers. RFPs aren’t without effort, time, and evaluation to determine which provider is best. RFPs are a useful tool to decide which sponsor to pursue bids from and…

Laura McWhinney

Clinical Trials

How to Make Your CRO Stand Out or Find that Perfect Fit

Without safe and well-designed clinical trials, drug development would lack necessary direction and evaluation. The industry knows how valuable clinical trials are and so do we. Our reports explore the myriad facets of this dynamic and crucial process to provide…

Laura McWhinney

Clinical Trials

Predictive Power of Perceived Leadership

The Industry Standard Research CRO Benchmarking reports contain service provider experiences and perspectives from recent users in the biopharmaceutical sphere. This information can inform sponsor organizations to make more educated CRO selections for their Phase I, II, and III studies.…

Laura McWhinney

Manufacturing

CDMO Performance on Service Provider Selection Criteria

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…

Laura McWhinney

Manufacturing Supply Chain & Logistics

Industry Trends: Clinical Trial Logistics Outsourcing

Clinical Trial Logistics Market Dynamics 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…

Tim Eggert

Manufacturing

Tracking the Evolution of CDMO Selection Criteria for Biologic Drug Substance Manufacturing

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…

Jenn Holloway

Manufacturing

How Industry Benchmarks Can Inform CDMO Selection

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…

Laura McWhinney

Articles

Decentralized Clinical Trials: Evolving Post-Pandemic

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…

Laura McWhinney

Articles

Sponsor Perspectives on Outsourced Clinical Trial Logistics

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…

Brandon Allison

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…

Brandon Allison

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…

Brandon Allison

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…

Brandon Allison

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…

Brandon Allison