Drug Development Strategy
What is the Clinical Trial Research Phase of Drug Development?
Drug development strategy is crucial to the success of a clinical trial study. A drug or device in its clinical research stages (following the preclinical phase), aims to generate an understanding of the safety and efficacy of a new investigational product by testing the product on healthy volunteers (when suitable) and/or a targeted patient population. This stage includes determining an appropriate dosage for the investigational product, the patient population, and the endpoints to measure the drug’s effectiveness.
Obatica’s Drug Development Strategy Services
At Obatica, we understand that the creation of your drug development plan in its initial stages is key to gaining sufficient insight into the safety and efficacy of your drug. This insight is key to progressing to the next stage of your drug or device development journey, and eventually being able to gain market approval and a successful commercialisation. The right strategy may potentially save a lot of time and cost to the overall study. Clinical trial specialist that has years of real life experience as principal investigator and also medical monitor would be able to provide a sound and intelligent strategy for your product.
Book in for your free consult here to learn more about our drug development services.
An early investment in a high-quality drug development plan is a great way to set up your clinical solution for eventual regulatory success.
Obatica’s Drug Development Services
- Drug Development Strategy
- Literature review
- Country specific treatment landscape report
- Review of clinical trials landscape
- Review of standard of care landscape
- Key opinion leader engagement
- Study design
- Protocol Writing and Development
- Clinical Study Reports and summaries for submission to regulatory agencies
- IB review
- PICF writing and patient information sheets
- Study Safety Monitoring
- Medical monitoring
- Medical director oversight
- Treatment landscape review/disease area and patient population recommendation
- Study Publication review and guidance
- Medical writing for abstract and manuscript
- Support and assistance with conference/journal submissions