Pre-Phase I Services
•Pre-Phase I Services
Drug Product Feasibility Assessment
Our proprietary Drug Product Feasibility Assessment is the cornerstone of Camargo's Pre-Phase I services. This important tool enables our clients to make the "go/no go" decision regarding a given drug's market potential and clinical development feasibility. Armed with our intelligence, including details of key factors influencing the pharmaceutical marketplace, the regulatory status and the clinical strategy involved in development of a specific drug, clients can make well-informed drug development decisions and avoid unnecessary and potentially destructive financial risks.
This assessment includes detailed data pertaining to the specific drug. A proposed clinical development plan is an invaluable feature of the assessment, along with a schematic of the proposed plan. Incorporating major decision points and cost estimates, it covers clinical pharmacology, preclinical studies, pharmacokinetics and regulatory recommendations. The feasibility assessment is a critical first step in the race to drug approval.
Pre-clinical Services
Ready to guide you through the preclinical stage of drug development, Camargo provides strategic support in the following areas:
- CRO selection
- Study design
- Study set up and execution
- Project management
Clinical Program Development
In clinical program development, our focus is unwavering: streamline the clinical trials process and move products from the early stages of clinical development through to FDA approval as efficiently as possible. Using proven methodologies for integrated clinical program development, we can meet FDA guidance requirements and expedite the drug approval process while decreasing time-to-market and reducing study costs.
Clinical design expertise in:
- Bioavailability
- Bioequivalence
- Comparison
- Dose-ranging
- Drug Interaction
- Drug metabolism
- Efficacy
- Patient preference
- Proof-of-Concept
- Quality of Life
- Radiopharmacology
- Safety
Our experts develop a customized clinical program plan for each drug that includes only the services necessary for preparation and hands-on implementation. The standard operating procedures at Camargo Pharmaceutical Services meet or exceed best practice in the pharmaceutical services industry, so you can rest assured of the high efficiency and effectiveness of every clinical development program that we develop.
Protocol Design & Implementation
When clinical design and protocols are complete, Camargo's team of experts move from planning and design to implementation, all the while working in close partnership with our client. We tap both our in-house expertise and our proven outsourcing resources to increase speed-to-market while maintaining high levels of efficiency and performance excellence.
At Camargo, we integrate knowledge from scientific and regulatory teams to develop a clinical plan and protocol that both meet regulatory requirements and anticipate market needs. Our seasoned medical writers apply their proven research and investigation skills to design protocols that streamline the clinical trials process, reduce study costs and expedite the drug approval process.
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