Camargo Phase I-IV Services

Comprehensive Clinical Development Services

Camargo's knowledgeable pharmacokineticists work diligently to determine the proper PK study designs needed to support a successful clinical drug development plan while avoiding unnecessary and costly studies. Expertise includes Phase I PK data analyses — both compartmental and non-compartmental — and interspecies scaling for first-time studies in humans. In addition, our PK staff has highly specialized competency in the bioequivalence study process.

PK expertise includes, but is not limited to:

• Design of pharmacokinetic studies in humans and animals
• Pharmacokinetic data analyses (compartmental and non-compartmental analyses)
• Interspecies scaling
• Bioequivalence study design and data analyses
• Clinical endpoint study design and data analyses
• Preparation and submission of the human clinical trials section of the NDA regulatory application

Phase I, II and III Studies

Quality performance, timeline management and cost control are our watchwords at Camargo as we navigate you through Phase I, II and III. In Phase I development, while a 505(b)(1) may take up to 6.5 years to reach an INDA submission, the 505(b)(2) pathway requires a fraction of that time and often allows preclinical and clinical analyses to be completed in parallel, abridging the process even further.

Pre-Study and Course-of-Study Activities:

• Study design and protocol writing
• IND preparation and submission
• Bioanalytical lab selection
• Bioanalytical method selection and validation review
• Management of institutional review board (IRB) submissions
• Case report form (CRF) development
• CRO selection
• Tracking and communication of milestones

Post-Study Activities:

• ICH reports
• FDA presentations, interactions and communications
• Presentations at scientific meetings
• Manuscript writing
• Preparation of annual reports

Phase IV Studies

Camargo approaches Phase IV studies with the same knowledge, diligence and efficiency as we do for clinical studies in Phases I through III. Our clinical and regulatory experts expedite the Phase IV clinical process from beginning to end via a streamlined, highly practical process that uses established methodologies and well-focused studies.