Phase 1 Studies

Novum PRS expertise in performing Phase I / Bioequivalence studies is based on over 30 years of scientific study conduct.  Our dedicated study project teams are guided by significant clinical experience for various study types and therapeutic areas. 

Offering complete support of clinical study design, clinical study conduct, integrated data management, and statistical analysis Novum PRS is your partner with flexible Phase I / Bioequivalence resources of 550 beds at our three clinical locations:  Pittsburgh, Houston, and Las Vegas.  In addition to having common SOPs for each of our clinics, initial and ongoing training modules universally support each of our clinical operations.  Experience designing studies for FDA, TPD and EMEA, Novum PRS’ Pharmacokinetic and Biostatistics team is involved throughout the study to final report.

Novum PRS Phase I

•       Bioequivalence / Food effect

•       Absolute bioavailability

•       Drug-drug interaction

•       PK-PD / Proof-of-concept

•       Women’s Health

•       Oral dosage, Nasal Delivery, Rectal and Vaginal routes of

         administration

•       PK & safety for topicals & TDDSs

•       Irritation and sensitization (cumulative irritation & HRIPT)

•       Sensitivity and safety testing

•       Vasoconstrictor studies for topical corticosteroids

 

Novum PRS offers solutions of proactive study design, clinical capacity, on-time recruitment and partnership in expediting timelines of final reports.