Data Management & Biostatistics

Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies

Risk-Based Monitoring (RBM) makes an impact. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...

Data Management & Biostatistics

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results.  As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive...

Clinical Research: Phase 1 - Phase 4

Outsourcing-Pharma – Trials suggest long-acting antipsychotics use should be expanded

Outsourcing-Pharma – Trials suggest long-acting antipsychotics use should be expandedQ&A with Andreas Schreiner, M.D., Executive Director, Medical Affairs Neuroscience & Analgesia

Consulting

Parkinson’s: Why Has Disease Modification Failed — and What Now?

Researchers have made many attempts at disease modification as they pursue breakthroughs in treating Parkinson’s disease, but so far without success. Why have these efforts failed, and what’s next in treating this degenerative disorder that affects an estimated 10 million people worldwide? We tackled these questions in a Premier Research webcast, The Potential for Disease...

Clinical Research: Phase 1 - Phase 4

Outsourcing-Pharma – Clinical trial logistics for the schizophrenic patient

Outsourcing-Pharma – Clinical trial logistics for the schizophrenic patientQ&A with Andreas Schreiner, M.D., Executive Director, Medical Affairs Neuroscience & Analgesia

Clinical Research: Phase 1 - Phase 4

Finding the Path to Disease Modification in Parkinson’s Disease

Among common degenerative disorders, Parkinson’s disease strikes more frequently than all but one: Alzheimer’s. Parkinson’s affects about 1 percent of the population over age 60 and claims 60,000 new diagnoses in the United States each year.[1] The cause of Parkinson’s remains a mystery, and the dopamine promoter levodopa — notwithstanding its limitations — has been...

Clinical Research: Phase 1 - Phase 4

Neuropathic Pain: What It Is, How It’s Diagnosed, How It’s Treated

Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts with...

Clinical Research: Phase 1 - Phase 4

The Potential For Disease-Modifying Therapies In Parkinson’s Disease

Parkinson’s disease is a progressive neurodegenerative disease that strikes its victims in the prime of their lives. Most available treatments have remained largely unchanged for years, with Levodopa the “gold standard” for treating Parkinson’s disease for nearly 50 years, with only marginal advances in improving the drug’s efficacy. It also only targets the symptoms, not...

New Research Highlights the Challenges of Studying Alzheimer’s Disease

Recently, researchers at King’s College London published a study in Translational Psychiatry on a feedback loop underlying brain degeneration in Alzheimer’s disease (AD) that, they suggest, may be the reason so many clinical trials targeting this disease have failed. In this new study, the researchers found that when amyloid beta (Abeta) destroys a synapse, the...

Clinical Research: Phase 1 - Phase 4

The Role of Long-Acting Injectable Antipsychotics in Schizophrenia

Use of long-acting injectable antipsychotics is often reserved for patients with chronic or treatment-refractory schizophrenia or repeated non-compliance issues. However, recent studies have consistently found a role for these treatments both soon after diagnosis and in the treatment of chronic disease. A severe and often debilitating neurodevelopmental disorder, schizophrenia affects a person’s ability to think...