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Industry Trends: Clinical Logistics Outsourcing

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 Reports
March 2, 2023
Articles

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…
ISR Reports
February 28, 2023
Articles

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…
ISR Reports
February 10, 2023
Articles

Decentralized Clincial 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…
ISR Reports
January 27, 2023
Articles

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
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…
ISR Reports
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…
ISR Reports
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…
ISR Reports
April 7, 2022