Ryan Speer Baudax Bio Non-Opioid Pain Drug Approval: In February, FDA granted approval to longtime Lotus client/ collaborator Baudax Bio’s non-opioid postsurgical pain therapy ANJESO. Lotus designed and performed both the Phase 2 and Phase 3 programs for this drug, with extensive scientific..
In September 2019, Lotus acquired HD Research, a network of specialty US analgesic research sites run by board certified anesthesiologists Harold Minkowitz, MD and David Leiman, MD. The core mission of our combined company is to standardize recruitment of chronic pain clinical trials using the same methodology Lotus used to standardize recruited models in acute … Read more
The conduct of PONV clinical trials has significant impact on their assay sensitivity. This is in part due to the strict experimental controls needed to demonstrate an effect in PONV, which are sometimes contrary to standard clinical practice. Rescue vs. Prophylaxis One key study conduct issue to manage in PONV trials is the threshold for … Read more
At Lotus Clinical Research, the safety of our patients, employees and customers remains our highest priority.
In the coming weeks and months, in accordance with public health department…
September is Pain Awareness Month! Lotus Clinical Research’s mission is to reduce prescription drug misuse and abuse by inventing and validating scientific technologies that improve analgesic study design and conduct.
When it comes to subject dropouts, an ounce of prevention is worth a pound of cure. Lotus Clinical Research has created a subject and investigator education series that can reduce subject dropout rates.
The prevailing soft tissue acute pain surgical models (hemorrhoidectomy, herniorrhaphy, hysterectomy, laparoscopic cholecystectomy, colon surgery) are slow to recruit and present financial and logistical challenges
Bunionectomy as an Analgesic Model In analgesic clinical trials, selecting the type of model to use can be challenging as each has their own pros and cons. As an analgesic model, Bunionectomy has excellent assay sensitivity. In the paper linked below our Chief Scientific Officer, Dr. Neil Singla, discusses the clinical and experimental characteristics of four acute surgical … Read more
Measuring Respiratory Depression in Analgesic Studies Demonstrating that a novel analgesic provides pain relief but does not cause respiratory depression can be a significant challenge. Our Chief Scientific Officer, Dr. Neil Singla, has extensive expertise in clinical trials focusing on the evaluation of respiratory endpoints in analgesic studies. In a Phase 2b study in acute pain, … Read more
3rd Molar Extraction as an Analgesic Model In analgesic clinical trials, selecting the type of model to use can be challenging as each has their own pros and cons. As an analgesic model, 3rd molar extraction has excellent assay sensitivity. Additionally, because of its low cost and rapid enrollment, it can be used to cost effectively dose … Read more
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