Outsourcing

 Washington Editor, jillwechsler7@gmail.com.

Articles

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions. 

Clinical Trial Modernization Raises FDA Compliance Issues

Feliza Mirasol is the science editor for 

One can use modeling methods to generate data and shorten development timelines in preclinical studies.

Adopting a Modeling Approach for Preclinical Studies

Having a clear clinical strategy early on can shave time off overall development projects.

Early Strategizing Tightens Development Timelines

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

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.