5 Traits To Look for in Your IxRS Project Manager

By Jen Burstedt, Marketing & Communications

Running a clinical trial is like steering a large boat: it takes the effort of many strong individuals to ensure that you end up going to the destination you’re seeking.
• A dedicated leadership team
• A hardworking crew
• A solid vessel
You risk the danger of being unable to reach your intended destination.

By the same token, IxRS providers as well as other service providers for biopharmaceutical companies are collaborators in a given clinical trial. Without diligent, responsive partners, the trial itself can be put in danger – as shown by recent examples of trials whose data was potentially rendered unusable due to one of these service providers.

If you’re part of the clinical team, the IxRS Project Manager who was assigned to you is an inadvertent partner to gathering data.

Here are traits to look for in your Project Manager in order to give you a greater likelihood for success (and if your PM doesn’t share these traits, perhaps you should consider looking for another partner).

  1. Flexible: your Project Manager understands that your trial is unique and has a specific design which needs to work with the IxR system; they do not advise you to modify or compromise your trial for the sake of a simple IxR system.
  2. Responsive: even if your PM doesn’t know the answer to questions, they’ll let you know quickly and professionally that they are working on a solution. A quick response time indicates that you are a priority for them and that they know how to effective work within their organization to get questions answered.
  3. Consultative: as an average Project Manager who has been at the company for more than six months has been exposed to at least 20 projects, they should be able to offer you advice on how to better run your trial. They may offer a suggestion for a way to modify the design of the IxR system itself based on their past experiences – which, even if you decide not to take their advice, is a good sign that they are critically thinking about the best way which your IxR system should work given the current protocol.
  4. Organized: having a Project Manager that keeps a meeting running smoothly, sends out meeting agendas and meeting notes as well as meets deadlines are all desirable signs of a highly organized Project Manager.
  5. Solution-oriented: sometimes, obstacles appear that your IxRS Project Manager or clinical team couldn’t have expected. Protocol amendments, difficulty in enrolling subjects, First Patient In moved with little notice. The trait that separates the ordinary versus the go-getters is the ability to search for and propose solutions for you.

Bracket has experience in working with hundreds of IxRS projects across continents since 1998. If you’re interested in learning more about our experience and solutions via Bracket RTSMclick to schedule a demo or contact us at info@bracketglobal.com

Bracket Presents Recent Findings at AAIC 2013

By Cheryl Selleny, Marketing & Communications

The latest research in dementia was revealed last week at the 2013 Alzheimer’s Association International Conference in Boston. The conference brought together leading researchers from around the globe to share their discoveries and study results, bringing the world one step closer to finding a cure for Alzheimer’s disease. Professor Keith Wesnes, Practice Leader for Cognition, and Dr. David Miller, Therapeutic Area Leader for Dementia, presented their recent findings. To view the posters, click on the links below.

Cognitive Evidence in Alzheimer’s Disease Patients that Compromised Hippocampal Neurogenesis is Related Both to APOE4 Status and CSF Abeta42
By Keith Wesnes, PhD
This study provides the first behavioural data from Alzheimer’s patients that compromised neurogenesis is linked to APOE ϵ4 status, and also related to a major biomarker for the disorder.

Memantine Improves Attention and Verbal Episodic Memory in Parkinson’s Disease Dementia and Dementia with Lewy Bodies: A Double-Blind Placebo-Controlled Multicentre Trial
By Keith Wesnes, PhD
This study provides the first evidence that memantine can improve attention and memory in these two types of dementia using automated tests of cognitive function.

Separation of Drug Effect from Placebo Control in AD Trials: Improving the Chances
By David S. Miller, MD, MA
This study provided evidence that utilizing both enriched training and IR2 (in-study ratings reliability program) effectively produced raters who separated drug from placebo in a large, multi-national AD study.