Study Start-Up

Quality

Operational Challenges of Neuroscience Clinical Trials, Part 4: Assessment Subjectivity

In this blog series, we’ve been discussing some of the challenges of conducting clinical trials in neuroscience. In our final post of the series, we turn to another major one: ensuring that assessments are conducted with high quality whilst also minimizing subjectivity. Rating subjectivity can make signal detection substantially more difficult, if not impossible. This...

Medical and Regulatory Affairs

Operationalizing Gene Therapy Trials

To achieve operational excellence in gene therapy trials, sponsors must understand – and overcome – obstacles ranging from start-up regulations and site selection to patient recruitment and retention. Gene therapy holds promise for treating a wide range of diseases, from cancer and diabetes to rare genetic disorders. It has also sparked great interest because it...

Clinical Research: Phase 1 - Phase 4

Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs

Your company has received funding for a first-in-man trial of a novel oncology compound. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of regulatory hurdles to form a robust clinical strategy. And you recognize that the success of the drug — and possibly the company...

Clinical Research: Phase 1 - Phase 4

Study Start-Up: Why You Really Need to Get This Right

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why we...

Clinical Research: Phase 1 - Phase 4

Tackling Common Issues in Gene Therapy Trial Operationalization

Between navigating relatively uncharted territory and the practical limitations of most gene therapy delivery systems, ensuring successful clinical trials of these products is a serious challenge for even the most experienced researchers. Compounding this is the long-term nature of most gene therapy trials — it’s not unusual to have follow-up periods of a decade or more....

Clinical Research: Phase 1 - Phase 4

Premier Insight 237: That Was Easy

Regulatory Submission Filed a Full Year Ahead of Schedule This case is a story with no drama. No sudden crisis.  No last-minute rescues. It’s about a clinical trial that ran perfectly from start to finish. And that in itself is a story worth telling. The sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID)....

Clinical Research: Phase 1 - Phase 4

Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost...

Project Management

Pharmaceutical Outsourcing – Fueling Success: The Sponsor-CRO Partnership

Clinical trials can be dauntingly complex. The high-stakes culmination of years – sometimes decades – of research, they involve rigorous data requirements, close regulatory scrutiny, intricate logistics, and intense cost pressures. Add the stress of trial outcomes sometimes being a make or break proposition for the sponsor, and it makes sense to hire a professional...

Consulting

Six Things You Need to Know About Medical Devices and Cybersecurity

Concern over cybersecurity touches our lives in new ways almost daily. Today, there is growing concern over millions of people who use connected medical devices that use off-the-shelf software. Here are six things the FDA’s Center for Devices and Radiological Health wants you to know about the safety of networked medical devices: 1. Hacking of...

Project Management

PM360 – Best Practices for Forging Strategic Sponsor-CRO Relationships

A true strategic partnership has benefits for both the sponsor and the contract research organization (CRO). The partnership is grounded in working together towards a common goal, and for both the sponsor and the CRO the success of one is the success of the other—with processes and talent evolving on both sides to produce enhanced...