Outsourcing

Feliza Mirasol is the science editor for 

Articles

Applying modeling methods in preclinical studies can be a powerful tool for generating data and shortening development timelines.

Using a Modeling Approach to Preclinical Studies

 Washington Editor, jillwechsler7@gmail.com.

New guidance from FDA and legislation from Congress promote clinical trial diversity.

Clinical Trial Diversity Advances in Regulatory Agenda

Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.

NCI Awards ATCC Task Order to Provide Cancer Epidemiology Services to Research Community

Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.

Huma and AstraZeneca Partner to Accelerate Innovation for Digital-First Patient Care

William Bakewell, PhD, is research fellow, GMP Lab, at PPD Clinical Research Services, Thermo Fisher Scientific.

Optimizing the use of partners for clinical trials depends on selecting the right contractor.

Selecting and Optimizing the Right Manufacturing Partner

Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.

Insights into Outsourced vs. In-house Clinical Trial Services

Under the expanded agreement with Agios, Centogene will provide global clinical trial support for thalassemia and sickle cell diseases.

Centogene Expands Rare Blood Disease Partnership with Agios

The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.

Recro to Expand its Clinical Trial Services Offerings

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.

FDA Promotes Master Protocols to Modernize Clinical Trials

Natalie Balanvosky is just-in-time manufacturing solutions manager, Almac Clinical Services.

Bryan Thompson is production manager, Almac Clinical Services.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.