Industry Articles

Phase I Clinical Development and Service Provider Selection

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…

Brandon Allison

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

Clinical Trials Technology

Why Are Sponsors Using More Than One CTMS Provider?

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…

Tim Eggert

Technology

Considerations When Selecting an Interactive Response Technology Provider

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…

Jocelyn Reynolds

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 Supply Chain & Logistics

The Value of Strategic Outsourcing Relationships

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…

Kate Hammeke

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

Manufacturing

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…

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

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