In the pharmaceutical and biotechnology industry more small and even virtual companies are established thereby changing the traditional way of working in early drug development. In the last decade there evolved a trend to obtain Proof of Concept (PoC) as fast as possible directly in patients instead of healthy subjects or as part of an …
Solutions for Recruitment for Pediatric Clinical Trials
Did you know that only about 20 percent of drugs used today are labeled for pediatric patients? By necessity, products licensed for adults are often given to children without adequate safety and dosing information or pharmacokinetic data. In fact, according to the FDA, most drugs prescribed for children have not been tested in children. Fortunately …
Spreading Early Clinical Knowledge
Shoulder to shoulder with our clients, we at QPS like to share the results of our early clinical research efforts, published in the scientific literature. Learn more by reading: A Phase 1, Single-center, Double-blind, Placebo-controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Clinical Effects, and Pharmacokinetics-Pharmacodynamics of Intravenous Cyclopropyl-methoxycarbonylmetomidate (ABP-700) after a Single …
QPS Tapped for Two New FIH Studies
Two companies have just selected QPS Netherlands to conduct their First-in-Human studies. Acticor Biotech, a Paris-based biotechnology company focused on the treatment of acute ischemic stroke, selected the QPS facility in Groningen, The Netherlands, to manage a Phase I clinical study. The goal of the study is to assess safety and tolerance as well as …
QPS Study Shows Estetrol Promising for Prostate Cancer Treatment
An investigation into the efficacy and safety of Estetrol (E4) for potential use in the treatment of advanced prostate cancer demonstrated decreased testosterone levels along with acceptable safety parameters. These results suggest that E4 may be suitable for standalone or combination treatment with androgen deprivation therapy (ADT). QPS Netherlands performed the Phase II randomized, double-blind, …
QPS’ Patient Recruitment Management at the 2016 Annual Meeting of the Clinical Trials Community in Israel
Patient recruitment is one of the most critical foundations of any clinical trial. Effective patient recruitment sets the trial down a path toward success if done well, or can create a road full of potholes if managed incorrectly. On April 11th, Barbara Derler, PhD, heading the EU patient recruitment team from the QPS site in …
QPS Global Clinical Operations Team Aces Enrollment for a Global Study of a Prostate Cancer Drug
QPS has been assisting an international Sponsor to perform a global, late-phase study to investigate the safety, efficacy, and pharmacokinetic behavior of an investigational drug in subjects with advanced prostate carcinoma. The original enrollment goal was 133 patients to be enrolled in approximately 18 months. The QPS Global Clinical Operations team enrolled 137 patients at …
QPS Global Clinical Operations Team Aces Enrollment for Global Study of Prostate Cancer Drug and Completes the First Patient in Europe!
QPS has been assisting an international Sponsor to perform a global, late-phase study to investigate the safety, efficacy, and pharmacokinetic behavior of a newly formulated investigational drug in subjects with advanced prostate carcinoma. The original enrollment goal was 133 patients to be enrolled in approximately 18 months. The QPS Global Clinical Operations team enrolled 137 …
Consultation open on revised EMA Guideline on Medicines to treat Alzheimer’s Disease
The European Medicines Agency (EMA) has released a draft guideline revision on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias for a six-month public consultation. The EMA considers dementia a key public health priority and sees early stage intervention and prevention of symptomatic disease as particularly worthy goals. This …
Read the QPS Whitepaper on Phase I Site Selection to support EU Registration
Making the right decision about where to conduct Phase I of a clinical trial is crucial. As long as basic EU regulatory requirements are fulfilled, the investigational site may be located anywhere in the world. This paper will walk you through the three key essential considerations for clinical trials intended to support registration in the …
