Miscellaneous

  • Endocrine – Female Sexual Arousal Disorder
  • Hepatology – Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Neurology – Parkinson’s Disease
  • Obesity
  • Orphan Diseases – Central Precocious Puberty
  • Pain – Healthy Volunteers
  • Pain – Pain
  • Respiratory – Healthy Volunteers
  • Respiratory – Seasonal Allergic Rhinitis
  • Urology – Overactive Bladder
  • Women’s Health – Bacterial Vaginosis
  • Wound Healing – Venous Leg Ulcer
Miscellaneous_02

Integrium’s Miscellaneous Clinical Trial Experience

Indication Phase # of Patients (Actual) # of Sites Location Services
*Hepatology, Non-Alcoholic Fatty Liver Disease (NAFLD) II N/A 30 U.S. Project Management, Monitoring, regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, CSR Writing
Neurology, Parkinson’s Disease I 40 4 U.S. ABPM
N/A, Obesity IIIB 66 7 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Medical Management, Data Management, CRF Development, Biostatistics, ABPM, Protocol Development
Orphan Disease, Central PrecociousPuberty II 36 10 U.S. Data Management, Biostatistics
Orphan Disease, Central Precocious Puberty III 36 10 U.S. Data Management, Biostatistics
Pain, Healthy Volunteers I 36 1 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing
Pain, Healthy Volunteers I 24 1 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing
Pain, Healthy Volunteers I 24 1 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, ABPM, Protocol Development, CSR Writing
Pain, Pain IV 1522 400 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing, Manuscript Development & Submission, FDA Consultation as needed
Pain, Pain IV 120 5 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing, Manuscript Development & Submission, FDA Consultation as needed
Respiratory, Healthy Volunteers I 64 1 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing, DSMB Management
Respiratory, Seasonal Allergic Rhinitis III 555 28 U.S. Project Management, Regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing, cDISC Mapping
Respiratory, Seasonal Allergic Rhinitis IV 255 1 U.S. Project Management, Monitoring, Data Management, CRF Development, CSR Writing
Respiratory, Seasonal Allergic Rhinitis II 295 20 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, cDISC Mapping
Respiratory, Seasonal Allergic Rhinitis II 625 25 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, CSR Writing, cDISC Mapping
Respiratory, Seasonal Allergic Rhinitis II 460 10 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments, Medical Management, Data Management, CRF Development, Biostatistics, Protocol Development, CSR Writing
Urology, Overactive Bladder III 290 60 U.S. ABPM
Women’s Health, Bacterial Vaginosis III N/A 35 U.S. Project Management, Monitoring, Protocol Development
Women’s Health, Bacterial Vaginosis III 255 20 U.S. Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Contracts & Payments, Medical Management, CRF Development, Protocol Development
Wound Healing, Venous Leg Ulcer IIB 120 9 South Africa Project Management, Monitoring, Regulatory Collection, Submission & Tracking, Site Selection, Site Contracts & Payments