G-CURE makes your cardiovascular drug a success by building on decades of cardiovascular research experience and utilizing our vast network of experts in the field of drug development.
Added value
Do you have a promising cardiovascular drug, and are you looking for scientific advice on how to proceed with its development? G-CURE has the expertise required to develop and deploy a research and development plan designed to answer your questions and generate maximum added value for your drug within the shortest possible time, on a reasonable budget, encompassing the full spectrum from preclinical trial to Proof of Concept clinical study.
First, G-CURE will thoroughly examine all available data on your compound to evaluate its potential for becoming a successful cardiovascular drug. Once we have established the opportunities of your compound, we will assemble a team of experts who will develop a research and development plan. This plan will be based on the anticipated pharmacological profile of your drug, current state-of-the-art knowledge of the target disease, the pharmacological target of your compound and the requirements set by regulatory authorities.
Pre-clinical, Phase I and Phase II studies
G-CURE can implement every facet of your research and development plan, providing an optimal environment for translational medicine. The division of Experimental Cardiology is part of the UMCG’s department of Cardiology and operates state-of-the-art facilities for pre-clinical pharmacology and toxicology studies.
Phase I and IIa studies are conducted in close collaboration with PRA International and QPS, who both have their phase 1 units on the premises of the UMCG. PRA, QPS and the department of Cardiology have extensive experience in conducting fast track phase 1 safety and tolerability studies, with the addition of small groups of patients for early efficacy evaluation. Cardio Research, the dedicated research unit of the department of Cardiology, has over 20 years of experience in conducting Phase 2 and 3 efficacy studies. The UMCG can offer a wide array of techniques, such as PET scans, to add sophisticated scientific data to your drug profile.
Investigator Drug Brochure
The scientific data generated for your cardiovascular drug are the driving force behind its further development. G-CURE acknowledges the vital importance of high-level (pre-)clinical data presentation for the future of your compound and your company. The renowned scientists at G-CURE will consolidate these data in expedited (pre-)clinical study reports and scientific publications in leading scientific journals. In order comply with regulatory requirements, G-CURE will share and discuss the data with the EMA and FDA. Eventually, the data will be compiled into an Investigator Drug Brochure, which will constitute the basis for the marketing authorisation dossier and which may aid the sale of your drug to a third party.
Investigational plan
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