Project Management

Consulting

Six Issues to Consider for Rare Disease Pre-IND Meetings

Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. Pre-IND meetings with the FDA give sponsors the opportunity to discuss their unique development challenges and determine where regulatory flexibility can be justified. While the...

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...

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...

Project Management

Come Together: The Foundational Team for your Heart Valve Study

An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study. You build that foundation with your...

Consulting

Heart Valve Studies: 6 key players required for success

As market demand for AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) has exploded, companies face increasing pressure to rapidly deliver actionable clinical trial data. The key to success lies in the team. And the foundation of an effective team begins by understanding each role—and, where applicable, how to best select each...

Consulting

The 3 Ds of a Successful Strategic Sponsor-CRO Partnership

Want to know how to build strong strategic sponsor-CRO partnerships? Commit to the three Ds: Start with a dialogue that establishes the project’s direction, ultimately making a difference in the relationship. In these relationships, a CRO must bring to the table the supplemental expertise a sponsor doesn’t know they don’t have, but needs for success. 1. Foster a Dialogue Bidirectional communication is probably the...

Consulting

6 Tips for Strategic CRO-Sponsor Partnerships (And Why They’re Important)

Strategic partnerships between sponsors and CROs are an important part of today’s clinical research landscape. When managed effectively, these relationships provide customers with collaborative strategic resources that drive optimized solutions. Partnerships help ensure the continuity of project teams and operations, development of best practices for continuous learning, and streamlined resource planning and staffing. They can also provide...

Consulting

Premier Insight 260: The Russian Connection: Recruiting Hard-to-Find Patients from a Specific HLA Subgroup

At first glance, it seemed no more complex than any other global, randomized Phase 3 study. The devil turned up in the details. First challenge: overcome early patient screening failure rate of 70 percent At first, screening failure rates were discouraging at best – between 60 and 70 percent. We responded quickly, by expanding the...

Clinical Research: Phase 1 - Phase 4

Strategies for Finding ‘Hidden’ Patient Populations

A little less than five percent of the world’s population are estimated to suffer from more than 7,000 different types of known rare diseases. There are even more medical conditions where those who have them are too embarrassed to talk about what’s wrong or simply don’t know exactly what ails them. Yet, these individuals are...

Patient and Stakeholder Engagement

Premier Insight 252: A Novel Treatment That Worked So Well It Almost Derailed the Study

We were testing an autologous chondrocyte transplantation system to repair damaged knee cartilage. The problem was that patients felt great after treatment, and saw no need to make follow-up visits. But the FDA required us to track results for seven years. The challenge: To keep patients involved for seven long years, especially active young patients...