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LIFE SCIENCE TRAINING INSTITUTE

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INDUSTRY RESOURCES

02
Apr
Considering The Needs Of The Caregiver In Drug Development

There has been an increasing and requisite focus on the needs of individuals affected by chronic or life-limiting disease, which has in turn resulted in a focus on the development of possible interventions and how they are administered. The success of participation and retention of these patients in clinical research, advancement of the drug development process, and adherence post-commercialization require the involvement of another critical expert — the caregiver.

Posted in:Clinical,
29
Mar
What Should You Do After An FDA Inspection?

The FDA just completed an inspection of your firm, and one or more FDA Form 483 inspectional observations were noted by the inspection team. How and when your firm reacts to these observations is a significant decision. This article will provide guidance on what actions to take to minimize or avoid additional enforcement actions.

Posted in:Manufacturing,
27
Mar
Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?

Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

Posted in:Manufacturing,
12
Mar
4 Tips For Overcoming Common Clinical Trial Recruitment Challenges

The current approach to clinical trial recruitment is prolonged, costly, and inefficient and often causes major delays and challenges for research across multiple disease states. The vast majority (85 to 90 percent) of studies in the U.S. experience significant delays in recruitment and enrollment. Nearly one-third of trials under-enroll, and only 7 percent meet their target enrollment number on deadline.

Posted in:Clinical,
10
Mar
CRA Burnout: How Big A Problem Is It, Really?

Clinical research associate (CRA) turnover has long been a complex and challenging issue. We can recruit more CRAs, increase publicity in colleges, and introduce assessment standards. I could quote various statistics regarding turnover, but I won’t.

Posted in:Clinical,
Tags:clinical research,clinical research assistant,CRA,
07
Mar
Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit

It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

Posted in:FDA,

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