Addiction is a complex disease, often chronic in nature, which affects the functioning of the brain and the body—as well as causing serious damage to families, relationships, schools, workplaces, and neighborhoods. The most common symptoms are severe lack of control, continued use despite serious consequences, failed attempts to quit, tolerance, and withdrawal. Fortunately, continued research is leading to important new therapies that both treat addiction and prevent relapse. ERG research areas addiction experts stand ready to accelerate your programs.

Demonstrated Expertise in Key Indications

• Alcohol Detoxification
• Alcohol Relapse prevention
• Alcohol Use Disorder in Schizophrenia
• Binge Eating Disorder
• Cocaine Relapse prevention
• Nicotine: Smoking cessation
• Opioid Detoxification
• Opioid Relapse prevention
• Opioid Use Disorder
• Opioid: Use of injectable suboxone

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Biomarkers have become a critical tool in speeding the success of clinical research trials, enabling researchers to precisely pinpoint target patient populations, inclusion and exclusion criteria, and optimal trial endpoints. ERG’s extensive experience testing biomarkers in diverse therapeutic areas helps streamline this process, accelerating the path to approval.

Demonstrated Expertise in Key Indications

• Alzheimer’s disease/Mild Cognitive Impairment
• First-in-man studies
• Psychiatry
• Special patient populations

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QT/QTc studies are a key component of the safety database for any new drug application—so it is critical that all pooled data be developed in similarly rigorous studies. The standardized collection policies across the ERG research area network enable us to deliver data that can be collected swiftly, then harmonized with confidence.

• Thorough QT/QTc studies
• Crossover or parallel group studies to assess the potential of a drug to cause QT/QTc interval prolongation
• Collection of ECGs at multiple time points under tightly controlled settings that target a broad range of doses early in development
• Polarization studies

Nearly half of America’s adult population currently has impaired glucose metabolism. By 2050, one in three will have diabetes. Unless we do something. ERG research areas are invested in helping stop this epidemic.

• Diabetes mellitus
• Diabetes mellitus without mention of complication
• Diabetic retinopathy
• Diabetes with neurological manifestations
• Diabetes with other specified manifestations
• Diabetes with peripheral circulatory disorders
• Diabetes with unspecified complication

Phase I studies help researchers determine how a drug works, by understanding its clinical pharmacology. Having conducted over 2000 Phase I studies, ERG is known throughout the industry for excelling in these trials. Most Phase I studies are conducted in normal healthy volunteers (NHV); NHVs are also used as a cohort of a Phase I study in metabolic, neurologic, psychiatric, endocrine, and cardiac disorders. We have access to a wide range of healthy subject profiles, and, whatever your compound, we stand ready to help you explore its clinical pharmacology.

Demonstrated Expertise in Key Indications

• Absolute Bioavailability
• Bioequivalence
• Cardiac Safety, Thorough QT/QTc
• Drug-Drug Interaction
• Elderly Healthy Cohorts in Proof-of-Concept/Proof-of-Mechanism
• ETOH Interaction
• First-to-File
• First-in-Man
• Food Effect
• Patch Irritability
• Pharmacokinetic/Pharmacodynamic
• Relative Bioavailability
• SAD/MAD
• Tasting

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With morbid obesity on the rise, research is crucial to help mitigate long-term morbidity and mortality related to nonalcoholic steatohepatitis (NASH). ERG research areas are ready to lead the way. We have a strong history of successful clinical research trials in specialized populations; and every week we screen subjects suffering from diabetes or obesity for the presence of liver fibrosis, creating a deep pool of trial candidates.

As scientists continue unlocking the human genome, they discover new methods of diagnosing and treating neurological disease—and ERG is at the forefront of translating this basic research into clinical solutions by advancing neurological clinical research studies.

• ALS
• Alzheimer’s Disease
• Autism
• Cognitive Impairment
• Dementia
• Epilepsy
• Essential Tremor
• Huntington’s Disease
• Lewy Body Dementia
• Migraine
• Movement Disorders
• Multiple Sclerosis
• Parkinson’s Disease
• Primary Degenerative Dementia
• Seizure Disorders
• Stuttering
• Tardive Dyskinesia
• Tourette’s Syndrome (adult and adolescent)
• Vascular Dementia

Pain management is a leading public health challenge; the current opioid epidemic underscores the critical need for new approaches to both chronic and acute pain. ERG research areas are stands ready, delivering the expertise, facilities, and access to patient populations needed to accelerate drug development in this area.

Demonstrated Expertise in Key Indications

• Chronic Back and Neck Pain
• Complex regional pain syndrome (CRPS)
• Diabetic peripheral neuropathy (DPN)
• Fibromyalgia
• Neuropathic Pain
• Osteoarthritis
• Postherpetic Neuralgia (PHN)

Demonstrated Expertise in Post-Operative Pain Management Following Key Surgical Procedures

• Abdominoplasty
• Bariatric Surgery
• Bunionectomy
• Cesarean Section
• Herniorrhaphy (Pediatric and Adult)
• Hysterectomy
• Third Molar Extraction
• Total Hip Arthroplasty (THA)
• Total Knee Arthroplasty (TKA)

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Pediatric clinical research studies add crucial insight to the specialized regulatory dosing and therapeutic approaches required for children. ERG’s pediatric experts understand the nuances of these FDA-mandated pediatric/adolescent trials, which, as a sub-specialty of adult trials, require both different protocols and different techniques. Our pediatric-focused sites are prepared to accelerate your pediatric/adolescent studies.

Demonstrated Expertise in Key Indications

• ADHD
• Autism
• Bipolar Disorder
• Diabetes
• General Anxiety Disorder
• GERD
• Major Depressive Disorder
• Migraine
• Obesity
• Pain
• Schizophrenia
• Tourette’s Syndrome

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ERG was founded with a focus on debilitating mental health issues—optimizing our investigational sites and patient recruitment strategies to advance important therapies and helping bring dozens of much-needed medicines to market.

Demonstrated Expertise in Key Indications

• ADHD
• Anxiety Disorders
• Bipolar Disorder
• Eating Disorders
• Depressive Disorders
• Obsessive Compulsive Disorder
• Opioid Use Disorder
• Post-Traumatic Stress Disorder
• Schizoaffective Disorder
• Schizophrenia

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As outlined in their published guidelines, the FDA mandates that pharmaceutical sponsors conduct pharmacokinetic (PK) studies in patients with impaired renal and hepatic function. With deep experience in both recruiting and executing these trials, ERG is a powerful ally.

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At least 40 million Americans suffer from chronic, long-term sleep disorders each year, and an additional 20 million experience occasional sleeping problems. ERG’s specialized sleep labs and expert staff are dedicated to partnering in both early- and late-phase sleep trials to advance new therapeutics to market.

ERG also works with clients who are assessing sleep disturbance as a secondary outcome measure in psychiatric and neurological disorders. Examples include sleep disturbance in schizophrenia, wakefulness in patients with mild to moderate Alzheimer’s disease, and insomnia related to major depressive disorder. ERG is uniquely positioned to conduct these complex inpatient trials given the flexibility of the facilities, the customized PSG bedrooms, and the extensive training of both the technicians and the clinical/medical teams.

Demonstrated Expertise in Key Indications

• Chronic Fatigue Syndrome
• Circadian Rhythm Disorders
• Delayed Sleep Phase Syndrome
• Idiopathic Hypersomnia
• Insomnia
• Narcolepsy
• Restless Leg Syndrome
• Sleep Apnea
• Sleep disturbances as a comorbidity

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From e-cigarette dependence to the correlation of cigarette smoking and depression, tobacco clinical research studies add important information to our understanding of the consequences of tobacco use. ERG research area sites have honed the specialized expertise and site design needed to optimize patient participation and research outcomes.

• Clinical pharmacology studies assessing PK/biomarkers
• Tobacco exposure and abuse potential required for regulatory submission