Highly Experienced Clinical Trial Monitors
Key Clinical meets your outsourcing needs if you require monitors with extensive experience. The average monitoring experience in our group is approximately 17 years, although some have had industry experience for over 25 years working in diverse areas of drug development.
Our monitors manage and develop a productive relationship with their sites that includes frequent communication to ensure that the study protocol is being followed accurately, the data is reported correctly and that there is adherence to regulatory and drug compliance. They have a clear understanding of the sponsor's expectations and anticipated study outcomes. In addition, they have an excellent understanding of the drug development process as well as a comprehensive understanding of all federal regulations.
Key Clinical Executives
Ronald C. Kalooky, MBA, CCRA
PresidentRon has conducted Phase I – IV clinical research for major US pharmaceutical companies for over 35 years. He has been an independent clinical research consultant since 1993, working with pharmaceutical and device companies around the country. He holds a BS in Biology from the University of Florida. Ron is based in Raleigh, North Carolina.
Clinical Research Experience
- Study management and GCP compliance
- Regulatory review
- Site identification and recruitment
- Subject tracking
- Protocol review
- CRF review
- IC design and review
- Trip report and other forms
- Co-managing projects
- Central IRB selection
- IVRS selection
Therapeutic Area Experience
- Anesthetics
- Biologics (vaccines)
- Cardiovascular (including Angina, CHF, Hypertension)
- Dermatology
- Gastroenterology (GERD, IBS)
- Genitourinary (BPH)
- Hematology (including Stem Cell Research)
- Infectious Diseases (including HIV/AIDS)
- Male Pattern Baldness
- Medical Devices (Spine, Cardiovascular)
- Neurological (including Alzheimer’s, Multiple Sclerosis, Anxiety, Migraine, Depression)
- Nutrition (Pediatrics, pediatric and adult metabolic disease (PKU) and food allergies)
- OB/GYN
- Oncology (multiple tumor types adult and pediatric)
- Photodynamic Therapy (in oncology)
- Registries
- Respiratory (including Asthma, Bronchitis, Hospital Acquired and Community Acquired Pneumonia, Sinusitis)
- Rheumatology (RA and OA)
- Sleep Disorders
- Smoke Cessation
- Urology (BPH, UTI)
Karen A. Kalooky
Vice President and Executive DirectorKaren has over 20 years experience monitoring Phase I-IV clinical trials and six years assisting with IND/NDA submissions for a major US pharmaceutical company. She has a BS in Management and is based in Raleigh, North Carolina.
Clinical Research Experience
- Study management and GCP compliance
- Regulatory review
- Site identification and recruitment
- Subject tracking
- Protocol review
- CRF review
- IC design and review
- Trip report and other forms
- Co-managing projects
- Central IRB selection
- IVRS selection
Therapeutic Area Experience
- Biologics (vaccines)
- Cardiovascular (Congestive Heart Failure)
- CNS (Sleep disorders, migraine)
- Infectious Diseases (including HIV, Sinusitis, Community Acquired Pneumonia)
- Medical Devices (Spine, Cardiovascular)
- Metabolic (Hepatitis B, Hepatitis C)
- Neurology (Multiple Sclerosis)
- Nutrition (Pediatrics, pediatric and adult metabolic disease and food allergies)
- OB/GYN
- Oncology (multiple tumor types - head, neck, renal)
- Respiratory (Asthma)
- Rheumatology (RA)
Areas of Expertise
Key Clinical has extensive experience in drug, medical device and biologic trials in virtually all therapeutic areas including:
- Analgesia
- Biologics
- Cardiovascular
- CNS/Pain Management
- Dermatology
- Endocrinology
- Gastroenterology
- Genitourinary System
- Hematology
- Immunology
- Infectious Disease
- Medical Device
- Nutrition
- Oncology
- Ophthalmology
- Pediatrics
- Pulmonary/Respiratory
- Registry
- Rheumatology
- Smoke Cessation
- Transplant
- Vaccines