Profil has actively established cardiovascular research capabilities at a high, GCP conform level to support pharmaceutical cardiometabolic and/or cardiovascular developments. Headed by Dr. Thomas Jax (FACC, FESC) the department is familiar with all aspects of cardiovascular research and in particular with cardiac safety studies as recently demanded by the FDA.
FDA Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, Dec. 2008:
... To establish the safety of a new antidiabetic therapy to treat type 2 diabetes, sponsors should demonstrate that the therapy will not result in an unacceptable increase in cardiovascular risk ..."
Profil can therefore accompany the customers development with regard to cardiac safety and/or cardiovascular efficacy from “first-in-man” to “proof-of-concept” as well as through phase 3.
- Implementation of cardiovascular (CV) parameters into early phase protocols to enable timely assessment of CV side effects, together with ongoing consultation on cardiac safety and possible efficacy of compounds
- Cardiovascular safety studies: design, statistical and administrative support and organization. Ability to recruit large numbers of diabetic patients with or without CV diseases
- Combination of cardiometabolic and glucodynamic assessments to yield insight into therapeutic/ pleiotropic mechanisms
- Non-invasive cardiac and vascular methods available include: electrocardiogram (compatible with FDA requirements), “state of the art” echocardiography, high-resolution vascular ultrasound, tonometry (pulse wave analysis), venous occlusion plethysmography, magnetic resonance imaging, telemetry (including blood pressure and SO2) and spiro-ergometry
- Invasive procedures with cardiac catheters