February is Heart Month, a time to reflect on the importance of heart health and the incidence and impact of heart disease in the United States and worldwide. Despite advance in treatments and therapeutics, heart disease continues to be the leading cause of death in the United States and worldwide. Approximately one in four deaths, or more than 600,000 people, in the U.S. are a result of heart disease. Family history, presence of comorbidities and lifestyle factors are all key contributors to the risk of heart disease.
Thankfully, due to the contributions of our customer and partners, advances in medicine are leading to the development of new life-saving treatments, significantly reducing the risk or morbidity resulting from heart disease.
Cardiovascular studies can span all phases and types of research, including both medical device and pharmaceutical studies. These types of studies typically require collection of detailed information about specific blood vessels, lesions or devices, depending on the type of study. The flexible form design capabilities in iMednet allows designers to create embedded logs within the CRF to capture this detailed information.
In addition, new technologies and data sources, including wearables and other tools to regularly capture key biometrics, like blood pressure, outside the clinical trial site are being incorporated in cardiovascular study designs more and more. These types of studies are also often event-driven, meaning it can take many years to enroll patients. As such, ongoing engagement and retention can also be a barrier, so tools to support and enhance patient engagement are critical. Cardiovascular research teams need comprehensive, flexible eClinical and electronic data capture (EDC) solutions to meet the evolving requirements of study designs.
As new tools and technologies become more prevalent and the number of data sources increase, research teams need comprehensive yet flexible EDC technologies that allow them to seamlessly adapt. These new data sources present both new opportunities and challenges, and they require clinical research teams adopt new processes for collection, storage, analysis and reporting of data. The Mednet API is designed to simplify and streamline integration with other clinical research technologies, making it easier to collect, store, analyze and leverage clinical research data. The easy-to-use API enables research teams to quickly import and export data with a wide range of external applications and tools.
Extensive and complex adverse event (AE) collection is often a typical component of cardiovascular research studies. EDC systems typically require a separate event for the various types of cardiovascular events, such as stroke, bleeding, myocardial infarction, etc. Each type of adverse event will also have extensive Clinical Event Committee (CEC) forms, and operationally, the event type must trigger a specific event form related to the adverse event.
In the iMednet platform, adverse event forms can be collected with an identifiable event type, which triggers the specific event form, saving time while also reducing error rates, providing better data quality. The capabilities also enable the use of key words in the forms as automated process triggers. Patient type reports displayed on a patient record page help to tell the story for each trial participant.
The native iMednet Adjudication module also enables the CEC to easily access and record critical safety data, while managing the process online with a quick glance reporting tool and dashboards allowing for complete visibility to individual AEs, adjudication results, and summary metrics. The capabilities also enable the Adjudication Manager to easily see AEs still requiring adjudication along with those that are complete.
Understanding the unique nuances and requirements of cardiovascular studies is critical to success. Whether Mednet is building the study or supporting the process, Mednet’s technical project operations team leverages their deep therapeutic category experience to optimize the process and help research teams get their studies up and running quickly. Medical device, biotechnology and pharmaceutical companies, along with contract research organizations (CROs), around the world have leveraged the iMednet platform to conduct hundreds of cardiovascular trials of all types and phases, ranging from small, early-stage studies to large, global, registry trials. In fact, since Mednet’s founding over 21 years ago, the cardiovascular therapeutic category is the most widely researched on the platform. Mednet is proud to have supported customers conducting research to identify new and innovative ways to advance the care and treatment of heart and vascular diseases.
Mednet’s comprehensive EDC-centric, clinical data management system (CDMS) is designed to be highly flexible to enable fast and efficient study builds and execution of any type of clinical research. We’re here to help research teams access the tools they need to get their critical studies up and running as quickly as possible.
To learn more about the flexible iMednet platform and the team’s therapeutic category expertise, contact us.