SPECIALIZED SITES
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Research sites with CVD experience, patient access and strong operational structure
WIDE COVERAGE
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countries covered
SCIRENT combines the strengths of an academic research organization and a clinical research organization. It brings together deep scientific and medical expertise with operational capabilities. In addition, knowledge about medical standards in different geographies is key to success in successfully executing highly complex cardiovascular studies.
Despite international medical guidelines for cardiovascular diseases, differences in diagnostic and therapeutic standards still differ significantly within distinct geographic areas. Often, disparities exist between hospitals within the same country. These differences, as well as variances in reimbursements and access to technologies, may be critical for the success or failure of a clinical study when selecting the right research sites. Especially if a study requires enrollment of a specific disease subgroup, an in-depth knowledge of diagnostic and therapeutic established standards within different hospitals may be essential for your clinical investigation. Sometimes, smaller hospitals and private practices may lead to better recruitment pace and quality results compared to large tertiary referral centers. With that in mind, SCIRENT staff can provide an excellent network of hand-picked cardiovascular research sites that perfectly fit the individual research. One of our key competencies is the personal connection with the study sites and investigators and the ability to identify and solve problems to overcome recruitment or quality barriers.
At SCIRENT, our study start-up process is designed to accelerate cardiovascular clinical trials while ensuring compliance and accuracy. We specialize in site identification, site qualification, and EC/RA submission preparation to streamline the initiation phase. Our experienced team works diligently to optimize regulatory strategies, ensuring rapid site activation. With a focus on cardiovascular health, we leverage our extensive network of sites and investigators to identify the best locations for your study, reducing delays and facilitating a smooth start to your research journey.
Research sites with CVD experience, patient access and strong operational structure
countries covered
We believe in proactively mitigating risk and working closely with our sponsors to ensure their protocol aligns with site operations and patient perspectives. On that basis, our experts review study synopsis and protocols, bringing clinical and regulatory expertise in protocol development.
Beyond the review, we’ve also established a study specific internal leadership committee inclusive of a cardiologist, a medtech expert, a clinical pharmacologist, a project manager, a regulatory affairs officer, a lead CRA and key opinion leader (KOL) from our network that are based in the respective trial regions. This collaborative approach enables additional insight and proactive mitigation of risks as well as analyses of important performance drivers.
One of the primary challenges during the Study Start-up phase is navigating the complex and often varying regulatory and ethical requirements across different jurisdictions. Especially for medical device trials, each country and sometimes each region within a country still has unique submission processes, documentation requirements, and review timelines. These variabilities may offer significant advantages if one understands and knows how to best exploit the different local regulations. A meticulous approach to preparing submission packages avoids delays in study approval.
Identifying and activating suitable trial sites is another significant step during study start-up. Sites must be able to conduct the trial according to the protocol and have access to the appropriate patient population. SCIRENT evaluates the sites’ infrastructure, experience, and performance history, ensuring that sites are fully prepared and compliant with study requirements. SCIRENT has developed a robust and study-specific site qualification/selection process to minimize operational, logistical, and performance risks during study conduct. This is an important consideration as we fully recognize the significant impact such problems could have on your development strategy, funding milestones, and corporate objectives.
During the formal site qualification and selection process, we will evaluate important parameters such as:
Patient demographics and accessibility
Study support resources
Investigator accessibility and expertise
Specialty staff and assessment capabilities
The main reasons for failure are related to insufficient recruitment of study participants. Thus, developing an effective patient recruitment strategy is crucial during the Study Start-up phase. In chronic conditions like heart failure or valve disease, patients may be informed about an upcoming study, and the time for regulatory approval can be used to line up patients for screening and have them “ready” once the study is initiated. Also, after the study starts, there are multiple options for enhancing enrollment on an investigational site. At first, the real cause for underperforming must be identified to overcome. Mostly, the reason is staff shortage. Often, the study personnel of the research site is overloaded with multiple different items, and screening and enrollment of additional trial participants would result in a further increase in workload. Therefore, from the perspective of a research nurse or coordinator, low recruitment and enrollment rates are only understandable. That is why we at SCIRENT believe supporting the study sites is the key to success. Flying study coordinators that overtake different aspects of the study conduct (e.g., data entry in EDC, identification of potential patients in a hospital database) often significantly increase site performance and quality. In addition, sites with a trustful personal relationship to, e.g., CRA and sponsor representatives, are likely to perform better in patient enrollment.
Establishing a robust data management plan is essential from the outset. This includes selecting appropriate data collection methods, ensuring the interoperability of data systems, and planning for data storage, processing, and analysis. The challenge lies in anticipating the trial’s data needs, including the volume, variety, and velocity of data, and setting up systems that are both compliant with regulatory standards and capable of handling these requirements.
SCIRENT is always prepared to adapt to regulatory requirement changes, sponsor priorities shifts, or unforeseen challenges at trial sites. Flexibility and agility in responding to these changes are crucial to keeping the study on track.
Addressing these challenges requires expertise, meticulous planning, and effective communication. By recognizing and proactively managing these potential obstacles, SCIRENT is streamlining the Study Start-up process, laying the groundwork for a successful clinical trial.
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