Mat Med has worked in a number of different indications in the cardiovascular and metabolic arena including disseminated intravascular coagulation (DIC), stroke, coronary heart disease, acute coronary syndromes, and heart failure. We have provided assistance on multi-centre, multinational trials investigating the effect of exercise in subjects with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease in addition to extensive experience supporting a Biologic License Application (BLA).
We understand that the highly competitive field of cardiovascular and metabolic research is making it imperative that clinical trials run flawlessly and efficiently to meet demanding timelines. The high risk of trial failure means that drug developers, with their keen focus on innovation in science, must ensure that the many moving parts of their drug approval process are managed as seamlessly, timely, and cost-effectively as possible while maintaining regulatory integrity.
While drug developers are focused on precision in research, the pharmaceutical industry is accelerating. New developments in science, standards of care, and clinical technology require faster productive trial phases conducted with increased expertise and flexibility.
• Medical and scientific expertise comprises the foundation for sound protocol design and implementation, especially in complex trials.
• Navigating the changing regulatory landscape by anticipating regulatory queries and local nuances can noticeably accelerate the startup phase. It’s important to involve local regulatory experts who can articulate the optimal submission process.
• Increased collaboration among academic researchers, sponsors, investigators, and patient advocacy groups allows collective knowledge to be applied to increase recruitment and retention rates and increased data and outcomes integrity.
Our medical and scientific expertise positively impacts how we engage with sponsors, view protocols, consider patient care, analyze data, and ensure quality.