ARTICLES BY KATE HAMMEKE

• Outsourcers Are Feeling Uneasy About Continuity of Supply

  4/14/2022

  Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

• What's Happening In Cell & Gene Therapy Development?

  2/8/2022

  This ISR report provides support and direction for innovative companies looking to outsource aspects of their cell and gene therapy manufacturing and development through shared research highlights.

• A Combination of Functional And Full-Service CROs Supports Strategic Outsourcing

  8/5/2014

  Outsourcing has become part of the strategy of just about every business in the drug development industry. Subcontracting various procedures along the stages of development to outside firms adds value to the process by reducing fixed costs, shortening timelines, and offering access to external expertise.

• The Continued Evolution Of The Sponsor-CRO Relationship

  8/5/2014

  Not long ago, the dynamic between the sponsor and the CRO was purely that of a client/vendor. Contract research organizations were engaged to reduce fixed labor costs on the sponsor side for work that varied in demand.

• Can Integrated Service Providers Help Simplify Complex Clinical Trial Logistics?

  Various factors are causing the distribution of clinical trial materials to become more complex, and sponsors looking to engage a third-party logistics provider have multiple options, each with benefits and drawbacks. Data from Industry Standard Research’s Clinical Logistics Market Dynamics and Service Provider Benchmarking report will educate readers about current usage patterns and preferences for outsourced clinical logistics providers as well as what the future may bring.

• Decision-making Responsibilities When Outsourcing Late-Phase Studies

  A look at which departments at sponsor organizations are involved in the decision-making process and how much decision-making responsibility each department has for outsourcing various late-phase study activities.