Phase I - IV Clinical Development Services

At Camargo Pharmaceutical Services, our comprehensive clinical development competencies are marked by the efficiency and performance excellence that sets us apart in the drug development services field. We provide expertise in:

• Bioanalytical, clinical lab and clinical site selection and contract negotiation
• Clinical supplies management
• Clinical trials management and monitoring
• Data management
• Proof-of-concept
• Biostatistics
• Investigator recruitment and site identification
• Medical and drug information service
• Medical writing
• Quality assurance auditing

Pharmacokinetics (PK)
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. Ruth Stevens, PhD, vice president, scientific and medical affairs, offers keen insight into the approval process and FDA reviewers' requirements, gleaned through six years as a pharmacokinetic reviewer and team leader at the FDA. She oversees a highly trained staff of scientists, all of whom have PhDs in pharmacokinetics or are doctoral candidates.

Our 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. Applying this PK and biopharmaceutics proficiency, we are able to design and manage bioequivalence and clinical endpoint studies, as well as analyze data and report data and results in ICH format, as designated by the International Conference on Harmonization—a process which has resulted in numerous regulatory approvals for our clients.

Our 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. From protocol development through database lock and final report, you receive the highly personalized attention of a consistent, single source client advocate, who is responsible for efficient service and project management.

Biologics/"Bio-Betters"
Camargo's biologic drug development tool kit includes gap analysis, program management and thorough evaluation of drug differences. Our method establishes improved safety and/or efficacy for your bio-better product. Bio-betters are defined as biologics that are improved over the reference product. Applying technical design changes and navigating the best regulatory approach allows Camargo to efficiently advance your biologic-based drugs through regulatory approval.

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. With decades of experience in capturing and reporting appropriate data, Camargo's record of regulatory approval on first-cycle review for all types of FSA submissions bodes well for those seeking Phase IV approvals.