Lotus Clinical Research®, LLC has developed proprietary materials for patient education and staff training that consistently increase effect size by minimizing variability and placebo response in analgesic clinical trials.
A scientifically driven CRO and research site purposed for analgesic investigations
The classic CRO and site model no longer works for analgesic clinical trials. The industry has matured such that producing data on time and on budget simply meets baseline criteria. Clinical trial sponsors want more than just efficient project management. They also want program-wide scientific support to increase the probability of positive clinical trial outcomes.
Lotus Clinical Research is an operationally and scientifically driven CRO and research site whose expertise has been adapted to fit the needs of complex and nuanced analgesic investigations.
We have honed our analgesic study design and execution process since 2001 and continue to be the recognized leader in analgesic clinical research. Each portion of our offering reflects our specialty expertise.
Our Chief Scientific Officer, Dr. Neil Singla, has extensive experience in analgesic protocol design and is a nationally recognized key opinion leader in analgesic methodology. Through 13 years of correspondence with the FDA’s Analgesics Division, Dr. Singla has gained a unique understanding of how to efficiently navigate the agency’s regulatory framework.
In addition to a full-service CRO offering, Lotus operates a 40-bed, Phase 1-3 analgesic research unit located on the 675-bed Huntington Hospital campus in Pasadena, California. Our specialties include Acute Pain, Chronic Pain, Analgesic Phase 1/Proof-of-Concept, and Opioid-Induced Constipation.
Since our inception in 2001, Lotus has been inspected by the FDA on six occasions. All six of these not-for-cause audits resulted in positive comments with no 483s issued.
Nearly all hospital based research units are owned by the parent institution, which inevitably leads to an extended contracting process and a pain staking local IRB review cycle. Lotus has a unique private ownership business model that allows it to contract independently and utilize a central IRB, bypassing institutional bureaucracy for rapid study starts.