Clinical Trial Services

The Direct-to-Patient services include Pharmacy-to-Patient, Depot-to-Patient, and Clinical Site-to-Patient services.

Under the contract, Pharm-Olam will offer routine and response clinical services for the development of medical countermeasures.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.

Previous investments set a foundation for later efficiency improvements.

The future will bring changes for temperature-controlled container rental companies.

The company announced the status of new and ongoing clinical trial activities during the COVID-19 pandemic.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.

Catalent’s planning service is designed to assist in evaluating needs for launching and maintaining clinical trials.

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

The merger creates a combined organization with a leading position in the eClinical market.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

PCI Pharma Services and CSP Technologies will partner on protective packaging solutions for clinical trials and stability testing.

The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Logistics manufacturers are adapting to explosive growth in the use of direct-to-patient clinical trials. Michael Sweeney, director of patient-centric logistics at World Courier Group, discusses the new model’s impact.

The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

Demand is driving expansion and consolidation of formulation and clinical trial materials services.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.