Safety Pharmacology Testing
Cardiovascular safety pharmacology studies are essential for evaluating the potential adverse effects of new compounds on the heart and vascular system. These studies are a critical step before initiating Phase I clinical trials, as they provide key data to ensure the protection of patients and compliance with international regulatory guidelines.
Preclinical regulatory CRO
Established – 2000
We offer flexible administration techniques in both rodents and non-rodents, allowing us to adapt to the physicochemical properties of each compound, intended therapeutic use, and regulatory requirements. Trained personnel manage each route using validated procedures to ensure consistency, safety, and reproducibility
At Vivotecnia we conduct cardiovascular safety pharmacology studies in conscious, unrestrained animals using telemetry devices, aligning with ICH M3/S7A/S7B/S6/S9 guidelines. This approach provides physiological conditions that closely resemble the clinical setting, ensuring accurate and reliable data. We utilize in-house colonies of telemetry-implanted animals, enabling rapid study initiation and high-quality data collection. Also, our telemetry systems, provided by Data Sciences International (DSI), are GLP compliant and offer digitally encoded data, including device ID, battery status, and operational time.
The cardiovascular system is one of the primary areas of concern in drug development, since adverse effects on cardiac function can lead to serious safety issues and regulatory delays. To anticipate and mitigate these risks, Vivotecnia offers two complementary study approaches:
Conducted in conscious, freely moving animals using implantable telemetry devices. These studies allow the continuous monitoring of cardiovascular function under conditions that closely resemble clinical reality, ensuring reliable and regulatory-compliant data.
An in vitro assay designed to evaluate the potential of a compound to block the human Ether-à-go-go-Related Gene (hERG) potassium channel. Since inhibition of this channel is associated with QT prolongation and cardiac arrhythmias, the hERG test is a standard requirement in preclinical safety evaluation.
Pharmaceutical
Biotechnology
Advanced Therapy Medicinal Products (ATMPs)
Vivotecnia uses state-of-the-art telemetry systems and dedicated facilities to conduct cardiovascular safety studies in non-rodent species. Our telemetry rooms are designed to allow continuous data acquistion from conscious, freely moving animals in a controlled and stress–minimized environment.
We guide clients in using 6-month sata within ICH S1B frameworks for possible waiver of the 2-year study when justifiedAll procedures are performed under GLP conditions and in line with EMA, FDA, OECD and ICH guidelines.
Ensure the cardiovascular safety of your
compound. Contact our team to design
and execute a compliant and reliable
cardiovascular safety pharmacology
study.
