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Better Science.
Superior Results.

We are a full-service CRO focused on improving the scientific accuracy of CNS programs.

Bunionectomy as an Analgesic Model

Measuring Respiratory Depression in Analgesic Studies

3rd Molar Extraction as an Analgesic Model

Reducing Placebo Response

CRO Services

A scientifically-driven consultative CRO delivering across all phases of clinical development.
  • Analgesic Experts
  • Project Management
  • Site Selection & Monitoring
  • EDC & Data Management
  • Biostatistics & Patient Profile Reports
  • Medical Monitoring
  • Medical Writing
  • Quality Operations
View All CRO Services

Scientific Services

Specialized education and training for accurate results and outcomes.
  • Placebo Response Mitigation
  • Global Rater Training & Certification
  • Clinical Development & Scientific Consultation
  • Unified Site Methodology Program
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We are a specialty CNS CRO that supports all phases of development for novel drugs. We provide scientific leadership and have extensive experience with the CNS approval process.

0
CNS DRUG APPROVALS
0 +
CNS TRIALS COMPLETED BY WHOLLY-OWNED SITES
10
NUMBER OF FDA INSPECTIONS RESULTING IN A 483
LEARN MORE ABOUT WHO WE ARE

We are a specialty CNS CRO that supports all phases of development for novel drugs. We provide scientific leadership and have extensive experience with the CNS approval process.

0
CNS DRUG APPROVALS
0 +
CNS TRIALS COMPLETED BY WHOLLY-OWNED SITES
10
NUMBER OF FDA INSPECTIONS RESULTING IN A 483
LEARN MORE ABOUT WHO WE ARE

We are a specialty CNS CRO that supports all phases of development for novel drugs. We provide scientific leadership and have extensive experience with the CNS approval process.

0
CNS DRUG APPROVALS
0 +
CNS TRIALS COMPLETED BY WHOLLY-OWNED SITES
10
NUMBER OF FDA INSPECTIONS RESULTING IN A 483
LEARN MORE ABOUT WHO WE ARE

Scientific Leadership Team

Our Scientific Leadership Team reviews every new protocol at the bid stage to assess the potential study risks, and works directly with the Sponsor as well as the CRO Project Teams to mitigate them in advance of FPI and then continues to be available throughout the life of the trial. Every Lotus Study is assigned a Scientific Leadership Team member from this list of Clinicians, Research Experts, and Scientists.

Dr. Suresh MallikaarjunDrug Development/Clin Pharm
Dr. Glen ApseloffAbuse Liability/Clin Pharm
Dr. William MartinDrug Development/CNS
Dr. Mark BrodyNeurology/AD
Dr. Stephen TheinSleep/AD
Dr. Nella GreenInfectious Disease
Stacy DilzerClin Pharm/Renal/Hepatic
Luke KramerPatient Advocate
Janeen RosalesPhase 1/Special Populations
Dr. Dennis RuffPhase 1/Internal medicine
Dr. Emanuel DeNoiaPhase 1/Internal medicine
Dr. Richard WalovitchImaging/Pharmacology
Dr. Keith CandiottiAnesthesiology/Pain
Dr. Harold MinkowitzAcute & Chronic Pain /Anesthesiology
Dr. David LeimanAcute & Chronic Pain/Anesthesiology
Dr. Neil SinglaPain
Denise RobertsPain/NASH/General Medical
Dr. Sherwyn SchwartzEndocrinology/NASH
Clay DehnMetabolism/NASH/Clin Pharm
Dr. Paul Michael RamirezRatings Expert, Rater Training
Dr. Erin TiremanRater Training/CNS/Psychedelics/Addiction
Dr. Andrew CutlerPsychiatry/Neurology /Addiction
Dr. Judith Dunn Drug Development/CNS
Dr. Steve RomanoDrug Development/CNS
Dr. Daniel UmbrichtTranslational Medicine/CNS
Dr. Kimberly VanoverDrug Development/CNS
Dr. Daniel GruenerPsychiatry/Pain/Addiction
Andria ChastainPsychiatry/Addiction
Dr. Bernadette D’SouzaPsychiatry/Addiction
Dr. Sarah AtkinsonPsychiatry Adult/Pediatric
Dr. James WhalenPsychiatry/Addiction
Dr. M. Saleem IsmailAD/Psychiatry/Geriatric Psychiatry
Ashley PoolePsychiatry/Pediatrics

Network of Sites

Lotus is a science-driven, full-service CRO with a number of unique qualities that no other CRO can provide. One particular differentiator is that we are under common ownership with Evolution Research Group (ERG), which is a clinical site organization with 20+ wholly-owned clinical research sites around the US. 

Evolution Research Group (ERG)
Participate in a Trial
These sites conduct research across all indications in the following Therapeutic Areas:
  • Psychiatry
  • Neurology
  • Pain
  • Addiction
  • Phase 1 / Healthy Volunteers
  • Renal and Hepatic Impairment
  • Metabolic Disorders
  • Endocrinology

Because of this connection to ERG, Lotus’ Sponsors benefit from one-stop shopping for:

  • Molecule-to-market solutions
  • Full-service, specialty CRO
  • Industry-leading, Early Phase expertise
  • Top CNS/Pain/Metabolic Investigators
  • Placebo Mitigation Training
  • Rater Training
  • Compliance training
  • Highly trained clinical research staff
  • Harmonized SOPs & CAPA processes
  • Quality clinical unit, overnight facilities
  • Local & centralized recruitment expertise
  • Technology-driven management processes

News & Press

Neil Singla, MD- Public Comments on FDA’s February 2022 Draft Guidance for Industry

Below please find my comments on FDA’s draft document: Development of Non-Opioid Analgesics for Acute Pain: Guidance for Industry, dated February 7, 2022. I am a board-certified anesthesiologist and Chief Scientific Officer of Lotus Clinical Research, LLC, a contract research organization, regulatory consulting firm and research site network specializing in analgesic clinical trials.

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April 20, 2022

Press Release: Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant

Lotus Clinical Research worked closely with Innocoll on the design of both new Phase 3 trials, and is currently conducting both studies within our CRO and site network:

Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant

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May 25, 2021
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