Study Start-Up

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

Setting up an effective phase one trial for a novel investigational oncology product is rife with challenges. Every aspect from site identification to estimation and coordination of enrollment and safety review is interconnected. Nuance is important. What factors can affect, or even derail, the timeline? Who are the key influencers and experienced sites? Does a...

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

Considerations In Conducting Pediatric Clinical Trials

There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions...

Clinical Research: Phase 1 - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of...

Global Compliance

Data Protection Part 2: Ensuring Study Start-Up Compliance With GDPR

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blogpost, we focus on four GDPR articles that are relevant to study start-up. Article 131 As the data controller, the sponsor must provide a privacy notice...

Medical and Regulatory Affairs

Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships

Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.

Clinical Research: Phase 1 - Phase 4

Picking Neuropathic Pain Trial Sites? Look for Experience — Among Other Things

Of all the truisms that apply to clinical drug research, probably none is more universally accepted than this one: “There’s no substitute for experience.” But if you’re working in an indication that is not widely studied, selecting sites on the basis of experience can be difficult. That’s one of many subjects we addressed in a...

Clinical Research: Phase 1 - Phase 4

Neuropathic Pain Studies: Patient Selection, Study Design, And Clinical Trial Challenges

Treatment of neuropathic pain has been a challenge for drug developers for years. Opioids show limited efficacy and are subject to abuse. Tricyclic antidepressants, long considered first-line therapy, have been hampered by side effects and are still effective in only about one-third of patients. Treatment of neuropathic pain has been a challenge for drug developers...

Clinical Research: Phase 1 - Phase 4

Four Things You Need to Know About mHealth and the Dermatology Field

Advances in medical technology have opened the door for dermatology mobile health (mHealth) programs, and these same technologies have the potential to radically change dermatology trial designs. Here are four ways digital disruption in the dermatology field is benefiting both patients and providers: 1. Reduced wait times: Digital health assessments make time spent scheduling, traveling,...