clinCORE has a team of SMEs (Subject Matter Experts) that can provide consultative services from developing a Clinical Development Plan to filing a IND or a FDA NDA/BLA package leveraging their extensive experience in clinical development.
Early planning and the use of consulting services helps overcome the obstacles of getting products to market faster and more efficiently. Our SMEs and our proven process of operational excellence place you, the client, at the top of an ever-changing industry.
We use innovation to solve industry challenges that combine science and technology. We offer strategic consulting services in the following areas:
GAP & RISK ANALYSIS
This is technique clinCORE uses to determine what steps need to be taken in-order to move from the current state to the desired, and future state while identifying project goals and objectives and employing methodologies built on project management best practices and minimizing risk. clinCORE’s SMEs have been doing this for over 20 years and have proven processes. Learn More
clinCORE has a proprietary and proactive 4 step process for identifying, analyzing and improving upon existing business processes within an organization for optimization and to meet new quotas or standards of quality. Learn More
Clinical Process Validation is the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Learn More
clinCORE’s SMEs will provide comprehensive Regulatory affairs support to clients during all stages of the drug development process. We are well-versed in all aspects of the clinical trial submission process, to both IRBs/ethics committees and FDA. Highly qualified medical writers, regulatory staff, data managers, and statisticians work with your team to ensure the clinical, scientific, and regulatory success of every project – from pre-IND/IND/IMPD submission through marketing application submission and regulatory review. Learn More