The management of clinical projects is fundamental to the success of any study, and it is crucial to have the collaboration of the different project teams that guarantee quality and transparency in the deadlines and fulfilment of the planned objectives.
Project managers should approach each programme in an innovative way, analysing all phases, from the feasibility of the protocol, initiation of the study, selection of the research centre, recruitment of patients, definition of the patient recruitment strategy, execution of the project, to the delivery of the study results with reports and publications.
- Feasibility study;
- Multi-centre project management;
- Supplier management;
- Contingency plans and risk management;
- Manual of clinical operations;
- Communication plan;
- Team(s) training;
- Project management plan and metrics
Strategic Product Development:
It can start with a Gap Analysis or Due Diligence to better understand the path to a particular medicine or medical device. When outlining the drug development roadmap, there are key elements to consider, such as the design of clinical and non-clinical studies, understanding the requirements of the regulatory agency of the country in question and understanding the market vision. In today’s scenario, clinical development is an increasingly complex and multifunctional process, thus adapting an increasing scientific understanding of disease to the availability of real-world data in a regulatory (regulated?) envi-ronment.
Includes the regulatory strategy on initial product development, ap-plications for marketing authorisation and post-marketing authorisa-tion procedures.
efficient communication is a key factor in ensuring not only regulato-ry approval of a product, but, also in increasing scientific knowledge among health professionals.
From here begins the product life cycle journey:
The projects, to be financed on a regular basis, will be of the “bottom-up” type and will fall within the following typologies, according to the maturity of their development:
- Development of a proof of concept prototype (using as a starting point the outcome of translational/applied fundamental research projects)
- Clinical validation of prototypes and processes, whether in the area of experimental drug development, diets, medical devices (MD), or disease biomarkers, among others.
All projects should have a strong potential for translation into clinical practice. For clinical validation projects, there should be a well defined implementation plan.
If the projects aim to achieve biomedical innovation, the final product should be a medical device, in vitro diagnostic, implantable device, experimental medicine, diet, technology or intervention which should be subsequently clinically validated.
Research projects involving systematised, structured and robust collection of epidemiological information and real-life data with the ultimate aim of supporting decision-making by different stakeholders will also be considered.