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Premier Research is recognized as an industry leader in clinical research for acute and chronic pain. In the past five years, we have managed more than 170 trials and 70 consulting projects in analgesia treating more than 44,000 patients. We have conducted some of the largest and most important drug trials in pain in multicenter trials around the world and at our clinical research centers in the United States.
We have conducted trials for virtually every major class of analgesic as well as for new and novel delivery formulations of existing products including formulations of 24 of the top 25 pain drugs currently marketed. Our analgesia studies consistently achieve superior enrollment performance and low query rates, delivering reliable and repeatable results that demonstrate high assay sensitivity. A substantial number of the studies performed by Premier Research serve as key pivotal trials for NDA submissions.
Expert Network
Premier Research works closely with some of the world's leading scientists and experts in analgesia. These clinical development experts often serve as consultants on our studies, giving clients access to a wealth of experience and knowledge to help expedite their trials.
Novel Pain Model Development
We have also helped pioneer the development of new research models and new pain assessment methodologies that are now standard in analgesia drug development programs. We have an Analgesia Model Development Team which is focused on the development and validation of novel pain models. Their goal is to meet the challenges of present day drug development by developing models with a high degree of scientific validity that are also able to address such practical considerations as rapid recruitment and reduction in the signal-to-noise ratio. For example, successful development of the post-operative bunionectomy model has reduced patient recruitment times by 30-40% uses a small number of sites and provides assay sensitivity better than or equal to existing post-operative surgical models.
Other methodologies developed or refined by the Premier Research team include:
- Third molar extraction (wisdom teeth)
- Orthopedic/Podiatric surgery (bunionectomy and hammertoe surgery, knee arthroscopy, ACL repair, knee/hip replacement)
- General/Gynecologic surgery (hernia repair, cholecystectomy, hysterectomy)
- Pioneered Sciatic Block anesthesia techniques for bunionectomy
- Multi-day/Multiple dose designs for acute pain
- Dysmenorrhea repeated dose model
- Pre-surgical anxiety model
- Postoperative nausea & vomiting model
- Two stopwatch method for onset measures
Premier Research Regulatory Affairs has unrivaled experience with the FDA Division of Anesthesia, Analgesia, and Rheumatology Products (DAARP). Over 25 INDs have been submitted to DAARP covering a broadspectrum of analgesic mechanisms, methods of administration, and abuse resistant technologies. Virtually every type of IND amendment has been submitted, including Special Protocol Assessments, and every type of FDA meeting has been held to support these INDs. Three NDAs have emerged from this work, all of which were submitted in the eCTD format.
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