Outsourcing

Articles

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth. 

Phase III Study for Novel Ganaplacide/Lumefantrine-SDF Combination in Adults, Children with Malaria Announced

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

CellVax and Theragent Form Manufacturing Pact for Novel Cancer Immunotherapy Drug Candidate

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

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

Feliza Mirasol is the science editor for 

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

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards. 

FDA Nixes Approvals Based Only on Foreign Data

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