Experience/Therapeutic areas

At Novum, integrity is everything from the initial study design through delivery of a submission ready report.

Since 1972, Novum has provided study design and protocol writing, clinical study conduct, data management, pharmacokinetic and statistical analyses, report writing, services and more to the pharmaceutical and associated industries for conducting Early Phase studies in multiple areas such as biologics, novel formulations and generic drugs. We have three Early Phase Clinical Pharmacology Units in the United States with a combined 647 beds and conduct approximately over 200 studies annually.

Early Phase Study List: FIH, SAD/MAD, PK/PD, Bioequivalence, Biocomparison, DDI, Drug-Device, Human Factor Studies. I/S, Adhesion, VCA

The Novum Early Phase Clinical Pharmacology Units have experience with: Respiratory Products (MDI, DPI, and Nasal Sprays), Transdermals, Oral Dosage Forms, Biologics, Locally Acting Products, and Natural Source Products.

Project Management

Client satisfaction is critical – to you and to us. While Novum is a growing company, the small-company values upon which we were founded endure. Early Phase clients have access to senior team members before, during and after the project. Our team ensures quick turnarounds and flexibility during each step of your study. As an extension of your internal team, we encourage open communications, set clear expectations and strive to build trust throughout the relationship.

Our team of dedicated Project Managers, who serve as the single point of contact between the Early Phase Research team and the study sponsor, are key to the high level of satisfaction Novum clients enjoy. They partner with our sponsors from the initial request for a quote and study design through report delivery, always ensuring needed information is received and all questions are answered. They also coordinate visits to our clinics during the study. As the liaison between Novum and the sponsor, our Project Managers are accessible, accountable, reliable and skilled at facilitating the timely delivery of quality data and all study information.

Participant Recruitment

Novum recognizes that its valued participants are the most important part of any Early Phase study. We work meticulously to ensure participant safety and comfort during study conduct, and that work is reflected in our two largest sources of participants: repeat participants and participant referrals. In addition, Novum uses a comprehensive marketing program utilizing online, broadcast, and outdoor media, as well as community outreach events. With our multicity network of clinics, our database of more than 30,000 participants is broad, diverse and continuing to grow.

The database comprises healthy normal subjects, as well as special populations, including post-menopausal females, healthy elderly subjects, females taking oral contraceptives and hypogonadal males. As study designs become more complex and our clients’ needs evolve, we will continue to expand our reach and identify new participants and patient populations.

Study Conduct

Each Early Phase study is conducted by an experienced research team that includes certified physician investigators, board-certified physicians, pharmacy professionals, nursing professionals and clinical research professionals. Our company-wide training program provides each study team member with training in Good Clinical Practice and general Clinical Study Conduct Procedure. Additionally, team members are provided with study-specific training prior to the start of each study. Each of our clinical sites utilizes the same Standard Operating Procedures, thereby providing consistent, quality service.

This uniformity also allows us to seamlessly conduct studies requiring multicenter and multiclimatic conditions. Our robust processes help maintain compliance with study protocol, SOPs and all applicable regulatory requirements. With these practices, we are able to provide meticulous oversight to even the most challenging study, ensuring subject safety, comfort, operational control and data integrity, yet be flexible in meeting special study requirements and expedited study timelines.

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