Early Phase Clinical Research
Early Phase Clinical Research Services
Pharmaron’s Clinical Pharmacology Center (CPC), located in Baltimore, Maryland, focuses on full-service early-phase clinical research for investigational products (IP). Our experienced team, facility design and geographic location provide operational excellence that ensures precision and integrity for all studies. Our expertise in First-In-Human studies in various therapeutic areas, combined with our full suite of clinical pharmacology services, allows our team to advance drug development programs rapidly. The CPC team is also experienced in conducting 14C-hADME, TQT and DDI studies, which could be executed either as an integrated part of FIH studies or as standalone studies.
- Experienced medical team including PIs and PAs
- Experienced clinical operations team, including research nurses, CRCs and RAs
- Exceptional safety oversight and data reporting for rapid dose escalation
- Experience in all therapeutic areas
- 90+ hospital beds, including dormitories for 14C-hADME studies
- CLIA/COLA accredited clinical safety laboratory
- Extemporaneous compounding pharmacy for complex administrations
- Clario-preferred ECG collection site
- Full-service study management, including regulatory affairs, project management, medical writing, clinical monitoring, pharmacovigilance and quantitative pharmacology
- Bioanalysis of small molecules, biologics, cell and gene therapy products and biomarkers
- Biometrics including data management and biostatistics
Capabilities
Healthy Volunteer and Patient Recruitment
- Customized recruitment plan for each study
- Access to large recruitment pool to select the most qualified volunteer candidates
- Recruitment from our 20,000+ database, advertising campaigns and strict screening and multiple recruitment centers including academia, private practices and community hospitals
Thorough QT/De-risking QT for Cardiac Safety
- Expertise with design and development of cardiac safety studies
- Deliver ECG data with expert interpretation
Carbon-14 Human ADME Studies
- Integrated 14C human ADME studies
- 14C radiolabelling chemistry
- 14C-labelled IP administration (microtracer or macrotracer) and sample collections
- 14C-IP and metabolite analysis for mass balance, metabolite profiling and identification using AMS
- Oral and/or iv administration of 14C-IP for absolute bioavailability study and mechanistic study
Ethnobridging Studies
- Access to 1st generation Japanese subjects, with the network to recruit from a large ethnic population
- An experienced native Japanese recruitment department and clinical team
- A seamless and comfortable experience for participants during the entire process, from screening to the inpatient stay at the facility
- Support with language translation for non-English speakers
- Adherence to the appropriate native diet during the study
