Cardiovascular diseases (CVD) include a collection of disorders that affect the heart and blood vessels. These diseases represent the leading cause of death worldwide. Nearly 18 million people per year die as a result of CVD, according to World Health Organization estimates.
Treatment for CVD is challenging for many reasons, such as: the diverse neuroendocrine, inflammatory, metabolic, and immunological mechanisms involved, the presence of co-morbidities, and the use of multiple therapies. Furthermore, physiological parameters that influence a drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are often altered in patients with CVD. Thus, carefully planned trials for CVD drugs are required to ensure that all necessary data are obtained to facilitate informed decision making at each step of the development process.
Because of the variable presentation of CVD, dosing regimens must often be tailored for individual patients. To ensure a drug’s clinical utility, a thorough understanding of the PK and PD differences between CVD patients and healthy subjects is essential. Due to the complexities of CVD’s physiological processes, specialized expertise is often required to analyze and interpret the PK/PD data generated in CVD drug trials.
Nuventra’s Cardiovascular Experience
Nuventra can perform any of our wide range of services for drugs to treat Cardiovascular indications. Some of our recent project experience in this area includes:
- Clinical and Statistical Data Management
- CTD 2.7.1, 2.7.2
- Early and Late Stage Clinical Study Management
- Face to Face in Regulatory Authorities Meeting
- IND Authoring and Submission
- Management of Preclinical through Successful NDA
- Mechanistic Investigation of Gastrointestinal Side Effects
- PK Analyses and Reporting
- Preclinical Gold Standard in vivo Efficacy
- Preclinical Investigation to Eliminate REMS Requirement
- Preclinical Pharmacology
- Primary Author for Successful NDA
- Program Oversight and Project Planning
- Regulatory Writing and Submissions
- Site and Data Monitoring
- Study Design
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Nuventra has experience with a number of CVD indications, including:
- Acutely-decompensated Severe Congestive Heart Failure
- Chronic Heart Failure
- Congestive Heart Failure (CHF),
- CVD Prophylaxis
- Myocardial Ischemia
- Pulmonary Arterial Hypertension
- Septic Shock
- Vascular Restenosis
- Venous Thrombosis