CRO Overview

A scientifically driven CRO model for your analgesic investigations

The classic CRO 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 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 CRO offerings reflects our specialty expertise.


With extensive experience in analgesic protocol design and implementation, our Chief Scientific Officer, Dr. Neil Singla, 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.

Biostatistics

You can train most statisticians to perform the complex data imputation methods required for analgesic clinical trials; however, they cannot offer value beyond what you teach. The Lotus statistical team has years of experience processing and analyzing analgesic trial data. They have written numerous SAP’s and are distinctly familiar with DAARP’s position on analgesic imputation (including MMRM, LOCF, BOCF, and WOCF).


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Site Selection


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Data Management

Database tailored to analgesic research

Our analgesic database is part 11 and CDISC compliant with an audit trail and other key quality features. We use OpenClinica, which fulfills important baseline attributes while allowing for the specialized configuration required for analgesic report outputs. Our database is configured with the end goal in mind: analgesic primary and secondary endpoints.


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Protocol Writing by Analgesic KOL

As chairman of the APS and IASP clinical trial special interest groups, our chief scientific officer, Dr. Neil Singla, understands that certain protocol design elements predict success while others predict failure.


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Monitoring

Our monitors are highly experienced in reading and understanding the clinical charts of typical analgesic patients. They have experience with both outpatient and inpatient analgesic charting, including anesthetic records and surgical procedure notes. Monitors are also trained in placebo response reduction and the administration of analgesic questionnaires. Proprietary Lotus generated training tools allow them to efficiently pass this information on to site-level staff.


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Project Management

Lotus provides experienced project managers with skill sets that are well suited to the needs of analgesic trials. We apply classic clinical project management principles to effectively meet timelines and project milestones by optimizing lines of communication.


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