Contract Research Services

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.

New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

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

A strategic separation is designed to enhance the value and growth of Paraxel’s contract research services and Calyx’s imaging businesses.

A new facility near Frankfurt, Germany expands Avantor's geographic reach and supports the growing demand for scientific research and clinical trial sample storage.

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

Previous investments set a foundation for later efficiency improvements.

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.

The acquisition will bring four new GMP-compliant facilities to the PCI network in the United States, Germany, and Canada.

In replacing the retiring Paul Hegwood, Ricci Whitlow will oversee global clinical trial operations.

Drug development contract services company PPD announces initial public offering.

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.

Label management specialist, Prisym ID, announced that its clinical trial solution, PRISYM 360, has been chosen by CME to be part of a just in time clinical trials handling system for the Medicines Manufacturing Innovation Centre project.

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.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

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

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.

Sharp has invested US$650,000 into enhancing its Interactive Response Technology (IRT) solution.