Designing and Executing Observational Studies Using Registries to Collect Real World Effectiveness and Safety Data
Product Details
A new era is looming for all FDA-regulated firms. Are you ready?
Whether you make drugs, biologics or devices, you must demonstrate beyond doubt that your products are safe and effective. Otherwise, you’re out of business.
With the dawn of the era of evidence-based medicine, many tools have been developed that can prove the superiority of your products.
Question is ... do you know how to use them?
Will the observational studies you create deliver accurate, reliable data? Do you have the skill set to construct patient registries that are flawless ... or flawed?
If you answered “No” ... or even “I don’t know” ... then mark your calendar for Thursday, Dec. 9, and a 90-minute session that will get you up to speed.
This webinar features United BioSource’s Peggy Schrammel, an expert on outcomes research and an experienced designer of post-approval clinical trials and patient registries across multiple therapeutic areas. She’ll be your guide through the maze of requirements, standards and rules that could spell success for your products — or failure.
Without ever leaving your office, you’ll log on and discover:
- The fast-evolving views on the health-improvement and cost-saving potential of observational studies and patient registries
- Case studies of patient registries and observational studies — the well designed vs. the poorly designed
- Tips for using effectiveness, safety, HRQoL, satisfaction and resource utilization data to make your case to regulators and payers
- Best practices for building study teams capable of managing comparative effectiveness research (CER) and health economics and outcomes research (HEOR)
- And much more
The webinar is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Of course, Ms. Schrammel will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in clinical trial studies will benefit from taking part in this event — and they can do so at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.
Why risk poorly designed observational studies that can lead to unsafe study conditions, or registry misuse that can result in loss of data collection and data inaccuracies? Resolve to learn what you need to know. It takes just 90 minutes.