At SCOPE we specialize in pain management clinical trials — from mild and acute to severe, chronic, and breakthrough pain. Our expert team designs tailored strategies for drugs, devices, or combination products, managing every phase from concept to delivery.
SCOPE has conducted over 55 pain studies at more than 1,700 clinical sites, involving 12,000 patients across adult and pediatric indications. Our extensive network —comprising neurologists, pain clinics, palliative specialists, surgeons, anesthesiologists, general practitioners, and key opinion leaders — ensures rapid, accurate feasibility assessments and trial success.
Your program is overseen by experienced clinical research associates, project managers, and medical monitors who understand the nuances of pain studies. As pain is subjective, choosing the right instrument to measure the primary endpoint is crucial. Our experts advise on appropriate, guideline-compliant tools, including:
Primary pain endpoints must directly capture a patient’s pain intensity, as per FDA guidelines. Yet, paper diaries often burden patients, especially when in pain, impacting compliance and data quality.
At SCOPE, we minimize this burden by using electronic clinical outcome assessments (eCOA) such as ePRO and eDiary, enabling data capture via apps or web on tablets, smartphones, or PCs.
At SCOPE, we partner with select providers for electronic Clinical Outcome Assessments (eCOA). Our monitors train patients on self-rated pain scales and ensure timely data capture, while ongoing site communication maintains quality and consistency.
Our project managers identify and mitigate study risks early. For trial participants unable to self-report — such as young children — observers (e.g., parents, caregivers) provide Observer-Reported Outcomes (ObsRO) based on observable signs like wincing, crying, or squirming. Clinician-Reported Outcomes are similarly limited to observable data.
SCOPE has extensive experience in the requirements for handling of controlled drugs / narcotics with a network of local offices capable of ensuring compliance with local regulation and avoiding issues with handling.
e.g. acute myocardial infarction, hypertension, peripheral arterial disease (PAD), pulmonary arterial hypertension (PAH) and stable angina pectoris
e.g. allergy (allergic conjunctivitis/ rhinoconjunctivitis), dermatomyositis, primary immunodeficiency diseases (PIDs) and vaccination (hepatitis B, influenza, rabies, tuberculosis)
e.g. acute porphyria and type 1 diabetes
e.g. hematological malignancy, liver cancer, metastatic breast cancer, metastatic lung tumor, non-Hodgkin lymphoma, prostatic cancer, renal cancer, schwannoma resection, solid tumors, unresectable cholangiocarcinoma and urinary bladder cancer
e.g. caries prophylaxis
e.g. alopecia areata, hypertrophic scars and psoriasis
e.g. acute porphyria, hormone replacement therapies in women, type 1 diabetes and vitamin D deficiency
e.g. acute porphyria, cholecystectomy, colitis ulcerosa, constipation, fat absorption in HIV-infected patients, inflammatory bowel disease (IBD), intra-abdominal infections, irritable bowel syndrome (IBS), liver disease, cholecystectomy and unresectable cholangiocarcinoma
e.g. hepatitis B vaccination, hepatic impairment, liver cancer and liver disease
e.g. Alzheimer’s, asthma, colitis ulcerosa, osteoarthritis, Parkinson’s Disease, polymyalgia rheumatica (PMR), psoriasis and rheumatoid arthritis
e.g. allergic conjunctivitis, keratoconjunctivitis and retinopathy
e.g. acute porphyria, juvenile dermatomyositis, polymyalgia rheumatica (PMR), pulmonary arterial hypertension (PAH) and sudden sensorineural hearing loss (SSNHL)
e.g. cartilage defects, open Gustilo-Anderson grade IIIa/IIIb tibia shaft fractures and osteoarthritis
e.g. acute peripheral vertigo, acute sensorineural hearing loss (ASNHL), rhinoconjunctivitis and sudden sensorineural hearing loss (SSNHL)
e.g. bladder pain syndrome, prostatic cancer, renal cancer, renal dysfunction / failure
and urinary bladder cancer
e.g. hepatitis B, influenza, rabies and tuberculosis