When looking for a Cardiology CRO, it’s important to keep a few key points in mind. These include: the clinical research organization’s infrastructure and independence from an industry sponsor. These three elements will make a big difference in your research. Also, a reputable Cardiology CRO must have a high success rate in completing trials.
Cardiology CRO – Clinical research organization
The Division of Cardiology has long been an advocate for cardiovascular clinical research and is home to many ongoing studies. These studies span the breadth of clinical cardiology, including outcomes, comparative effectiveness, transplantation, mechanical support, electrophysiology, peripheral vascular disease, gene, and cell therapy, and pulmonary hypertension.
Both contract research organizations and academic medical centers have a significant role to play in the development of modern cardiovascular trials. Contract research organizations are hire by research sponsors, which may include drug companies, medical device manufacturers, or government agencies. Academic medical centers typically have an affiliation with a university and are not-for-profit corporations.
The Center for Clinical Cardiology is led by an internationally recognize physician and researcher. As a result, it has a reputation for leading research in both cardiovascular psychophysiology and cardiac surgery. The organization has dedicate lab space and state-of-the-art equipment for cardiovascular research. DCRI also offers a collaborative environment that fosters collaboration among researchers.
The emergence of CROs was facilitated by advances in technology. The introduction of inexpensive personal computers enabled researchers to solve many data-management challenges. Many CROs were able to conduct hundreds of trials at a time and apply economies of scale to the development of new technology. While AROs had historically held back in investing in new clinical-research technologies, CROs were quick to take advantage of these advances.
The division of Cardiology is home to several clinical trial teams. These include the heart-failure group and the cardiology clinical trials group. Each team focuses on specific aspects of heart and vascular research. Several of its faculty members also perform investigator-initiated research. The division of Cardiology manages over 400 clinical trials.
Clinical research cardiologist
As a clinician, your role in conducting clinical research can be very varied. For example, your role may include participating in research or being a principal investigator, or you may be responsible for enrolling patients in a clinical trial. Whatever the role, you’ll likely need to understand how clinical trials work and whether you’re a good fit for the role.
Clinical research is important for many reasons. For example, studies conducted by researchers are invaluable in determining which treatments or devices may be most effective in certain patients. Moreover, clinical trials can also save lives. Many advancements in medicine have been made thanks to clinical trials. Clinical research is the cornerstone of patient care. Clinical trials help doctors determine which treatments work best and which are harmful. This is because they provide the best evidence for making healthcare decisions.
The Division of Cardiology at UCSF maintains an active clinical research program. Multiple multi-center trials are being conducted by physicians in the division. This research program is supported by the National Institutes of Health, the American Heart Association, and nonprofit foundations. Clinical investigators work in areas as diverse as arrhythmias, pulmonary hypertension, and stem-cell research.
Often, community-based cardiologists are unable to participate in clinical trials because of lack of time or investigator experience. Therefore, they need ongoing funding for the infrastructure needed to conduct clinical trials, including the hiring of research nurses. In addition, they need to have financial incentives to dedicate time to clinical trials. This is a difficult task for physicians, who would rather concentrate on their patient care. These barriers must be overcome before these physicians can be considered as candidates for participating in industry-sponsored trials.
Infrastructure
The infrastructure for cardiology clinical trials is increasingly complex, and the CRO industry is adapting. To meet this growing demand, Cardiology CROs is forming strategic alliances with regional CROs and develops operational infrastructure to support these trials. These partnerships help the CRO commodities processes and scale them globally. Vial is one such next-generation Cardiology CRO, with over 125 employees and contributions to over 700 clinical trials.
Its goal is to improve clinical development by supporting a range of clinical research projects and accelerating the process. A well-established IT infrastructure will help a CRO speed up the clinical development process, but it needs to be accompanied by human coordinating processes. In this paper, we examine the genesis of the partnership between Genentech and Corning Besselaar, outline the key elements of the infrastructure, and describe the coordinating processes used to make this partnership a success.
Cardiology CROs is increasingly gaining market share in the biotechnology and pharmaceutical industry. As biotech and pharmaceutical companies to invest in the r&d, they are outsourcing an increasingly larger proportion of clinical trials to CROs. China, for example, has experienced a 79% increase in clinical sites from 2016 to 2018. The region also comprises more than half of the global population, making it a prime location for clinical trials.
Independence from industry sponsor
Independence from industry sponsor in cardiology CROs can be achieved through several ways. First, it promotes objectivity. Second, it reduces the possibility of bias and increases the credibility of a trial. Third, it protects the sponsor from securities issues. Finally, it preserves the right to modify a trial if needed.
Third, independent monitoring groups can identify issues that internal groups would miss. These groups evaluate individual events and the overall rates of study events and advise the sponsor about emerging concerns. While sponsors typically form internal groups to monitor their clinical trials, the input of external reviewers is often more objective and less biased.
Read also: Contract Research Organization List
Cost of clinical research
Cardiology clinical research is expensive. The cost of one cardiovascular drug trial alone topped $346 million. In the same year, a trial of a combination drug, sacubitril-valsartan, cost $174.3 million. The study’s results showed that the combination was superior to existing drugs, enalapril, and warfarin. However, the cost of cardiovascular drug development hasn’t always been this high.
For example, registry-based trials are more economical than conventional randomized trials. These studies typically pay a fee of $5,000 to $10,000 per participating site. The cost difference varies greatly based on study characteristics. The number of patients in a clinical trial, the number of data elements per patient in the registry, and the speed of research coordinators to manually abstract data were all factors that determined the cost savings.
A study by the Tufts Center for the Study of Drug Development found that one-third of trials require amendments that are avoidable. A major part of these trials involves monitoring and source data verification, which can take a significant amount of time. Furthermore, clinical trials are expensive because they often recruit too few patients.
In terms of length, cardiology clinical trials last an average of eight months. In contrast, respiratory and oncology trials last about five months and 36 months, respectively. Overall, the cost per patient per month for these trials is $2,375. This cost may be less if the trials are shorter than this.
Cost estimates are also subject to interpretation because they are based on standardized reporting and differing terminology. Therefore, studies using these data cannot properly adjust for disease severity.
Cardiology CRO and Women in Clinical Trials
In terms of cardiology trials, gender diversity is important. Women have historically been underrepresented in cardiovascular trials, and women are less likely to be considered as trial participants. Adding more women to the patient pool can help trials are more manageable and less time-consuming. According to the American Heart Association, women are more likely to die from ischemic heart disease than men, so it is critical that trials include more women. However, the low percentage of women in trials can also skew the results.
Vial CRO
Vial CRO is a next-generation Cardiology CRO, helping scientists discover new therapies for all types of human diseases. They use a technology platform to streamline clinical trials across the entire health care continuum. The company employs more than 125 people and has contributed to more than 750 clinical trials. The company is also beefing up its expertise in the field of oncology. It recently appointed Dr. Arati Rao as an initial member of its Scientific Advisory Board.
Vial’s technology platform enables end-to-end trial execution, making it one of the first CROs to offer a complete clinical trial management solution. This platform includes a modern Electronic Source and powerful tooling for CRAs. Vial is headquartered in San Francisco and employs more than 125 staff worldwide.
CROMSOURCE
CROMSOURCE is an ISO-certified international contract research organization that specializes in cardiovascular clinical trials. The company has offices in Europe and North America and has extensive experience in cardiovascular device development. Its expertise includes cardiac valves, vascular imaging media, and drug-elating stents.
CROMSOURCE leverages nearly 25 years of experience in drug development to provide clients with custom, tailored solutions. CRO professionals understand the critical importance of maximizing efficiency, time, and cost. They work with clients to meet their goals and budgets. They are also able to provide consulting services across a variety of disciplines and are flexible enough to work with a variety of timelines.
The medical device CRO market is highly fragmented, with a combination of established players and smaller startups. The largest market participants include CROs with more than 1,000 employees. Other emerging players include newer CROs with niche expertise.
