Pain
Dr. Vince Clinical Research (DVCR) offers broad capabilities in conducting pain-related clinical trials. Our team, under the guidance of Lynn R. Webster, MD, an internationally recognized clinical research expert in pain and addiction medicine, has conducted numerous pain-related studies, including new therapies for pain management.
Capabilities
DVCR can support a wide range of study designs in both healthy volunteers and patient populations for the development of new pain therapeutics at our physician-owned phase 1 clinical pharmacology unit and our global network of strategic site partners, including:
- First-in-Human (FIH):
- KSingle Ascending Dose (SAD) which may include:
- [Early QT/cardiac safety in partnership with Clario
- [Food Effect cohort
- KMultiple Ascending Dose (MAD) which may include:
- [Patient cohorts
- KCombined SAD/MAD which may include:
- [Patient cohorts
- NDA-enabling clinical pharmacology studies:
- KDrug-Drug Interaction
- KThorough QT/QTc in partnership with Clario
- KFood Effect
- KBioavailability/Bioequivalence
- KPharmacokinetic/Pharmacodynamic
- KRenal Impairment
- KHepatic Impairment
- Human Abuse Potential (HAP)/Human Abuse Liability (HAL)
Click below to receive more information on how our CRO can support your upcoming pain trial.
- Human Pain Models
- KBunionectomy
- KThird Molar Extraction
- KAbdominoplasty
- Experimental Pain Models
- KCold Pressor Test
- KUV-B Rays
- KCapsaicin (Intradermal, Heat-Capsaicin Sensitization, Heat-Capsaicin Warmth)
- KMustard Oil
- Ventilatory Response to Hypercapnia
- Phase Ib/IIa Proof-of-Concept (POC)
- Phase II multi-site patient trials
Capabilities
DVCR can support a wide range of study designs in both healthy volunteers and patient populations for the development of new pain therapeutics at our physician-owned phase 1 clinical pharmacology unit and our global network of strategic site partners, including:
- First-in-Human (FIH):
- KSingle Ascending Dose (SAD) which may include:
- [Early QT/cardiac safety in partnership with Clario
- [Food Effect cohort
- KMultiple Ascending Dose (MAD) which may include:
- [Patient cohorts
- KCombined SAD/MAD which may include:
- [Patient cohorts
- NDA-enabling clinical pharmacology studies:
- KDrug-Drug Interaction
- KThorough QT/QTc in partnership with Clario
- KFood Effect
- KBioavailability/Bioequivalence
- KPharmacokinetic/Pharmacodynamic
- KRenal Impairment
- KHepatic Impairment
- Human Abuse Potential (HAP)/Human Abuse Liability (HAL)
- Human Pain Models
- KBunionectomy
- KThird Molar Extraction
- KAbdominoplasty
- Experimental Pain Models
- KCold Pressor Test
- KUV-B Rays
- KCapsaicin (Intradermal, Heat-Capsaicin Sensitization, Heat-Capsaicin Warmth)
- KMustard Oil
- Ventilatory Response to Hypercapnia
- Phase Ib/IIa Proof-of-Concept (POC)
- Phase II multi-site patient trials
Click below to receive more information on how our CRO can support your upcoming pain trial.
DVCR’s state-of-the-art surgical suite seamlessly integrates surgical procedures and inpatient confinement within our phase 1 unit. Patients are prepped in our pre-operative room and taken straight to the dedicated procedure room. Following surgery, the patient is transported to our Post-Anesthesia Care Unit (PACU).
Our on-site surgical suite and recovery room enable DVCR’s medical professionals to perform surgeries safely and efficiently in a controlled environment while minimizing the risk of complications that can arise when transporting surgical patients between a surgical facility and research site. Both areas are equipped with continuous subject monitoring and emergency medical equipment.
Following surgery, patients are monitored in the recovery room before being transported to a private research suite. Located within DVCR’s phase 1 unit, these 8 private suites are supported by a dedicated nursing station and lounge area, ensuring continuous care and patient comfort.
Each member of our surgical team is experienced in the conduct of pain procedures. Our team consists of:
- Board-certified podiatric surgeons
- Board-certified anesthesiologists
- Certified Registered Nurse Anesthetist
- Site staff experienced in surgical pain model studies
- Experienced staff trained to collect subjective pain ratings as key data for pain model studies
DVCR’s state-of-the-art surgical suite seamlessly integrates surgical procedures and inpatient confinement within our phase 1 unit. Patients are prepped in our pre-operative room and taken straight to the dedicated procedure room. Following surgery, the patient is transported to our Post-Anesthesia Care Unit (PACU).
Our on-site surgical suite and recovery room enable DVCR’s medical professionals to perform surgeries safely and efficiently in a controlled environment while minimizing the risk of complications that can arise when transporting surgical patients between a surgical facility and research site. Both areas are equipped with continuous subject monitoring and emergency medical equipment.
Following surgery, patients are monitored in the recovery room before being transported to a private research suite. Located within DVCR’s phase 1 unit, these 8 private suites are supported by a dedicated nursing station and lounge area, ensuring continuous care and patient comfort.
Each member of our surgical team is experienced in the conduct of pain procedures. Our team consists of:
- Board-certified podiatric surgeons
- Board-certified anesthesiologists
- Certified Registered Nurse Anesthetist
- Site staff experienced in surgical pain model studies
- Experienced staff trained to collect subjective pain ratings as key data for pain model studies
The staff at DVCR possess expertise in the procedures for conducting assessments and questionnaires specific to pain and pain-related indications, including:
- Numeric Pain Rating Scale (NPRS)
- McGill Pain Questionnaire (MPQ)
- Brief Pain Inventory (BPI)
- Visual Analog Scales (VAS)
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- Modified Observer’s Assessment of Alertness and Sedation (MOAA/S)
- Clinician and Participant Global Impression of Change Scale
- Time to First Perceptible Relief and Meaningful Relief
- Post-Operative Nausea and Vomiting Intensity Scale
- Quantitative Sensory Testing (QST)
- PEG Scale (Pain, Enjoyment, General Activity)
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
- PainDETECT
- Neuropathic Pain Questionnaire (NPQ)
- Douleur Neuropathique 4 (DN4)
The staff at DVCR possess expertise in the procedures for conducting assessments and questionnaires specific to pain and pain-related indications, including:
- Numeric Pain Rating Scale (NPRS)
- McGill Pain Questionnaire (MPQ)
- Brief Pain Inventory (BPI)
- Visual Analog Scales (VAS)
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- Modified Observer’s Assessment of Alertness and Sedation (MOAA/S)
- Clinician and Participant Global Impression of Change Scale
- Time to First Perceptible Relief and Meaningful Relief
- Post-Operative Nausea and Vomiting Intensity Scale
- Quantitative Sensory Testing (QST)
- PEG Scale (Pain, Enjoyment, General Activity)
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
- PainDETECT
- Neuropathic Pain Questionnaire (NPQ)
- Douleur Neuropathique 4 (DN4)
When administering pain-related assessments and collecting data from clinical research participants, DVCR understands the importance of reducing variability and mitigating placebo response without diminishing treatment response. This requires in-depth training of both clinical site staff and participants. DVCR employs multiple methods to ensure consistency of data collection for pain clinical trials, such as:
- Training investigators and clinical site staff before and throughout the study
- Limiting the number of sites involved in the study to reduce variability
- Protecting enrollment across sites to emphasize enrolling the best participants instead of the most participants
- Conducting assessments in private rooms whenever possible
- Providing input to protocols to optimize the timing and frequency of questionnaire administration to ensure data quality
- Reducing interactions between raters and caregivers
- Limiting the number of surgeons at each site when surgical procedures are involved
By implementing the above methods and tailoring the approach for each individual protocol, DVCR works to ensure that placebo response can be mitigated.
Indications
DVCR’s investigators have participated in pain clinical trials across multiple indications. Additionally, for multi-site trials, DVCR has built a network of strategic partner sites that have vast experience enrolling patient populations.
Chronic Pain
Post-Operative Pain:
- Diabetic Neuropathy
- Migraine
- Gout
- Osteoarthritis
- Rheumatoid Arthritis
- Back Pain
- Fibromyalgia
- Neuropathic Pain
- Endometriosis
- Lupus
- Vaginal Pain
- Bladder Pain
- Post-herpetic Neuralgia
- Bunionectomy
- Abdominoplasty
- Third-Molar Extraction
- Cesarean Section
- Hysterectomy
- Total Hip Arthroplasty
- Total Knee Arthroplasty
Indications
DVCR’s investigators have participated in pain clinical trials across multiple indications. Additionally, for multi-site trials, DVCR has built a network of strategic partner sites that have vast experience enrolling patient populations.
Chronic Pain
- Diabetic Neuropathy
- Migraine
- Gout
- Osteoarthritis
- Rheumatoid Arthritis
- Back Pain
- Fibromyalgia
- Neuropathic Pain
- Endometriosis
- Lupus
- Vaginal Pain
- Bladder Pain
- Post-herpetic Neuralgia
Post-Operative Pain:
- Bunionectomy
- Abdominoplasty
- Third-Molar Extraction
- Cesarean Section
- Hysterectomy
- Total Hip Arthroplasty
- Total Knee Arthroplasty
Meet Our Experts
DVCR has assembled an industry-leading team of experts to oversee the design, planning and conduct of clinical pain trials at its world-class phase 1 clinical pharmacology unit and at our strategic partner sites. The following members of our company are heavily involved in the oversight, planning and day-to-day conduct of these clinical studies:
Lynn Webster, MD
Executive Vice President, Scientific Affairs
Bio
Rose Gerringer
Ratings Manager
Korey Nevitt
Executive Director, Site Partnerships
Bio
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners ensuring our multi-site studies are conducted by the most capable investigators that they are aligned with our commitment to speed, customer service and delivering the highest quality data possible to our biopharmaceutical clients.
Meet Our Experts
DVCR has assembled an industry-leading team of experts to oversee the design, planning and conduct of clinical pain trials at its world-class phase 1 clinical pharmacology unit and at our strategic partner sites. The following members of our company are heavily involved in the oversight, planning and day-to-day conduct of these clinical studies:
Lynn Webster, MD
Executive Vice President, Scientific Affairs
Bio
Rose Gerringer
Ratings Manager
Korey Nevitt
Executive Director, Site Partnerships
Bio
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners ensuring our multi-site studies are conducted by the most capable investigators that they are aligned with our commitment to speed, customer service and delivering the highest quality data possible to our biopharmaceutical clients.
Meet Our Experts
DVCR has assembled an industry-leading team of experts to oversee the design, planning and conduct of clinical pain trials at its world-class phase 1 clinical pharmacology unit and at our strategic partner sites. The following members of our company are heavily involved in the oversight, planning and day-to-day conduct of these clinical studies:
Lynn Webster, MD
Executive Vice President, Scientific Affairs
Bio
Rose Gerringer
Ratings Manager
Korey Nevitt
Executive Director, Site Partnerships
Bio
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners ensuring our multi-site studies are conducted by the most capable investigators that they are aligned with our commitment to speed, customer service and delivering the highest quality data possible to our biopharmaceutical clients.
