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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
Five Steps to CDMO SelectionManufacturing

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…
ISR Reports
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
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