Outsourcing

Jill Wechsler is Pharmaceutical Technology's 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

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.

Centogene Expands Rare Blood Disease Partnership with Agios

Craig A. Steger is SVP–Life Sciences at Outcome Capital LLC, 99 High St., Suite 2900, Boston MA.

Thomas J. Joyce is Associate at Outcome Capital LLC, 99 High St., Suite 2900, Boston MA.

Oded Ben-Joseph, PhD, is Managing Director, at Outcome Capital LLC, 99 High St., Suite 2900, Boston MA.

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.

Pharma Services Sector Poised for Continued Growth and Consolidation

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.

Contract Research Services