Clinical Program Development
Camargo’s focus is unwavering: Our integrated team approach will move your product forward as efficiently as possible. Using Camargo’s proven methodologies combined with our vast expertise and knowledge, we meet all applicable U.S. Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulatory requirements in order to execute regulatory-compliant clinical trials while reducing overall study costs.
Clinical Design Expertise
- Drug-drug interactions
- Special populations (renal, hepatics, elderly)
- Cross-over designs
- Drug interaction
- Drug metabolism
- Safety and efficacy
- Patient selections
- Placebo-controlled studies
- Non-inferiority/superiority studies
- Quality of life
Protocol Design and Implementation
Our seasoned medical writers — together with regulatory and medical experts — apply tried and trusted research and investigation skills to design protocols that streamline the clinical trial process, reduce study costs and expedite the drug approval process. When protocol design is complete, Camargo’s team moves from planning to implementation, all while working in close partnership with your team.
Comprehensive Clinical Development Services
- Bioanalytical, clinical lab and clinical site selection and contract negotiation
- Clinical supplies management
- Clinical trials management and monitoring
- Data management
- Investigator recruitment and site identification
- Medical and drug information service
- Medical writing
- Quality assurance auditing
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, Ph.D., chief scientific officer and executive vice president, offers keen insight into the approval process and FDA reviewers’ requirements, gleaned through six years as a pharmacokinetics reviewer and team leader at the FDA. She oversees a highly trained staff of scientists, all of whom have doctorates 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. By applying this PK and biopharmaceutics proficiency, we’re able to design and manage bioequivalence and clinical endpoint studies as well as analyze and report data and results in International Conference on Harmonisation (ICH) format — a process that has resulted in numerous regulatory approvals for our clients.
- Design of pharmacokinetic studies in humans and animals
- Pharmacokinetic data analysis (compartmental and non-compartmental analyses)
- Interspecies scaling
- Bioequivalence study design and data analysis
- Clinical endpoint study design and data analysis
- Preparation and submission of the human clinical trials sections 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 the Phase I, II and III development pathway. In Phase I development, while a 505(b)(1) may take more than six years to reach an NDA submission, the 505(b)(2) approval pathway requires a fraction of that time and often allows nonclinical and clinical analyses to be completed in parallel, abridging the process even further.
In certain instances, the 505(b)(2) pathway enables portions or even whole phases (II-III in many cases) of the development process to be circumvented. Dosing, regimens, and dosage forms are all examples where existing pharmacokinetic data may suffice for approval. If a Phase III study is needed, only one is generally necessary versus two, and it may have less extensive requirements (e.g., smaller study size).
Pre-Study and Course-of-Study
- Study design and protocol writing
- IND preparation and submission
- Bioanalytical lab selection
- Bioanalytical method selection/development and validation review
- Management of institutional review board (IRB) submissions
- Case report form (CRF) development
- Clinical CRO selection and management
- Tracking and communication of milestones
- ICH study reports
- FDA presentations, interactions and communications
- Presentations at scientific meetings
- Manuscript writing
- Preparation of annual reports
Phase IV Studies
With decades of experience in capturing and reporting post-marketing data, Camargo is your partner to help increase new drug marketability. Drawing on our relationships with seasoned marketing experts in the pharmaceutical industry, we build solid, highly customized strategies that incorporate regulatory and marketing objectives, and we develop a well-defined integrated action plan to maximize your drug product’s commercial potential. From strategic branding through carefully planned implementation, Camargo can help drive physician preference, consumer requests and sales.
- Abstract development
- Clinical presentations
- Document retrievals and literature searches
- Article writing for scientific publication
- Medical advisory boards and key opinion leader development