Solutions
I help you optimize your investments in clinical development.
Learn more about the range of services I offer. If you are interested in something that is not covered here, please contact me so we can work together to find a solution.
Solutions
Strategic Feasibility
With a strategic feasibility it is possible to provide a detailed and accurate assessment of the feasibility of conducting clinical studies in specific sites in Latin America, with a special focus on Brazil. Using a combination of market data, benchmark data and direct relational contact with sites, we provide comprehensive analysis that allows you to make informed and strategic decisions to conduct successful clinical studies.
Project Supervision
Although CROs offer diverse services and expertise, combining a differentiated approach with a Consultant who acts as Clinical Liaison & Project Oversight can mitigate many challenges by providing an aligned, dedicated and specialized solution. This strategy is especially beneficial for small and medium-sized studies, where the scalability and diversity of services of large CROs may have less impact. An executive who oversees CRO activities, integrating implementation strategy with execution, represents a significant competitive differentiator.
Clinical Development Consulting
Consultancy aimed at small and medium-sized companies in all phases of the development of new medicines. We offer strategic and operational guidance, maturity assessment, gap analysis, support in contacting international authorities and access to specialized consultants. Our focus is to build a path with the client to support their investment process from regulatory to delivery.
Pre-Inspection and Quality Management
Prepare for regulatory inspections with confidence through the Inspection Preparation Service. We start the guidance project with a full pre-inspection audit, identifying potential compliance issues and providing practical solutions.
We offer the implementation of a Quality Manager as a Service to support sponsors and centres that are not adapted to this demand.
Structuring Research Centers
Assessment of the performance of clinical research centers to increase operational efficiency and trial success, from infrastructure configuration to process optimization. We support your process of creating research centers in accordance with best market practices.
Training and development
Training programs designed to train clinical research professionals, ensuring the performance of high quality trials. We offer customized solutions, including training on ICH GCP guidelines, protocols, specific procedures, data collection and regulatory compliance. We also provide ongoing training to keep your team up to date on the latest developments in clinical research.
Recruitment Boost
Develop and implement innovative, tailored strategies to increase participant recruitment rates, ensuring your studies achieve the participation required to move forward successfully and on time. We use advanced technologies, provide on-site support with skilled personnel, and partner with partners to drive effective social media campaigns to maximize patient engagement and uptake.