Find out how our medical, regulatory, and operational expertise in cardiovascular clinical development can help with your next study or program.
Medpace is a full and active member of the
Cardiac Safety Reserach Consortium
The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through a MOU with Duke University to support research into the evaluation of cardiac safety of medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, “Think Tank Incubator” programs, and consensus white papers.
Medpace is home to renowned regulatory and therapeutic experts who are committed
to the complex and intertwined areas of cardiovascular clinical research.
With extensive experience in Phase I-IV research, our team of international therapeutic
leaders have dedicated their careers to bringing drugs to market that treat or prevent
heart disease. In fact, they have helped pioneer many of the preventative cardiovascular
compounds introduced in the last 15 years.
Medpace regulatory experts are former government officials who have invaluable insight
into the specific area of cardiovascular drug and medical device approval. They are an integral part
of every study and their valuable guidance ensures every step efficiently accelerates
the approval process.
Medpace experience in large cardiovascular endpoint trials
The Medpace ability to integrate cardiovascular trials with metabolic/endocrinology projects across both
therapeutic and regulatory knowledge bases provides sponsors with unique capabilities for
large studies demanding rigorous safety requirements.
Electronic endpoint adjudication
capabilities coupled with strategic consultation and management of all outcomes and regulatory
requirements, keeps projects on track.
- Acute coronary syndrome
- Coronary artery disease
- Heart failure
- STEMI and non-STEMI
Cardiovascular Site Identification and Feasibility:
Cardiovascular research often calls for high study enrolment which may lead to competition for
investigators and patients. Medpace is unique in the industry in terms of its many long-term relationships
with key Investigators and opinion leaders worldwide that specialize in cardiovascular trials. The
Investigators, many of whom are renowned scientists and opinion leaders in the field, are well-known to
the Medpace Medical Monitors and operations staff since they have worked with us for many years. These
relationships facilitate more accurate assessments of whether the objectives of a study can be met within
the proposed timelines. The rationale for the study design and, importantly, the proposed eligibility criteria
are discussed directly with Investigators. This leads to greater involvement of the Investigators in the conduct
of the study, which translates to better recruitment and study management.
Cardiac Safety - ECG Core Lab - Thorough QT Studies:
In addition to full-service CRO functionality
capabilities include core laboratory services in ECG technologies. The
Medpace ECG Core Laboratory
provides sponsors with reliable, consistent, and prompt electrocardiographic services in support of
global clinical development programs to support international Phase I–IV clinical trials. With the intense
focus on cardiac safety from regulatory authorities, Medpace also has the integrated services and experts
to manage the rigors of
Medpace Medical Device (MMD)
is a wholly-owned division of Medpace exclusively dedicated to the
design and conduct of medical device trials. MMD has vast experience in cardiovascular trials including:
- Coronary, Peripheral and Carotid Stents
- Aortic Valve Replacement
- RF Ablation for A-fib
- Endovascular interventions
- ICD/CRT-D and Pacemakers