Clinical Trial Management

At SCIRENT, we specialize in providing comprehensive clinical trial management services that cater to the intricate needs of clinical research. SCIRENT has developed a robust and study-specific site qualification and 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

With a steadfast commitment to advancing medical research, we leverage innovative strategies and state-of-the-art technologies to ensure the success of your clinical trials. Discover how our tailored approach can enhance your research endeavors and ensure compliance with the highest regulatory compliance standards.

Site Identification, Selection, and Management

As a specialty provider of cardiovascular research services, our clinical trial management services commence with an unmatched proficiency in Site Identification, Selection, and Management. Our team understands the pivotal role that the right site plays in the success of a clinical trial. Thus, we employ a meticulous approach, utilizing rigorous criteria and comprehensive evaluation processes to identify and select the most suitable sites for your studies. Our management practices are designed to ensure that each site operates at its optimal capacity, adhering to the strictest quality and compliance standards. Having conducted studies across all phases in 20 countries and 100 research sites in Europe, SCIRENT is well positioned to enable effective access to specialized, high performing and very responsive research sites while leveraging industry leading recruitment rates and mitigating potentially rate limiting challenges associated to: linguistic barriers between countries, differences in regulatory submission pathways, cultural variances between regional resources and study oversight staff.

Group of hospital personnel in a discussion, symbolizing SCIRENT's expertise in site management for cardiovascular clinical trials, ensuring optimal site performance and adherence to international standards across Europe

Our key differentiators are:

Longstanding relationships between SCIRENT and Lead Investigators

Regular motivational visits (video calls, onsite) to maintain Investigator engagement

Familiarity between the SCIRENT study team and proposed research sites

Delegated CRAs will be onsite to support with first screenings

Availability of flying study nurses or coordinators to promote quality and adherence

Direct and regular SCIRENT Leadership involvement during study conduct

Low turnover rate during project life cycle resulting in operational stability

Real time updates on study progress in addition to weekly meetings

Patient Recruitment

In clinical trials, Patient Recruitment efficiency significantly influences the timeline and success of your study. At SCIRENT, we employ innovative strategies and tools to streamline the recruitment process. Our approach is centered on identifying and engaging potential trial participants efficiently, ensuring a high retention rate and diversity within your study cohort.

In most clinical studies, only a few sites recruit a significant number of patients, while many active clinical sites fail to enroll patients. This discrepancy underscores the need to understand and address the reasons behind low recruitment rates.

Our experience has shown that sites that do not enroll patients within the first six months of initiation are unlikely to recruit at all. In such cases, closing these sites early to optimize resources is often more effective.

 

To enhance recruitment efforts, we adopt different strategies for chronic and acute conditions:

For chronic conditions, the key to successful recruitment lies in early identification and engagement. Before the study is officially approved and initiated, we identify suitable patients and inform them about the upcoming study. This proactive approach ensures that a pool of pre-identified patients is ready to participate as soon as the study begins, facilitating a smoother and quicker recruitment process.

For acute conditions, it is crucial to ensure that a larger team is fully aware of the clinical study and capable of independently identifying, consenting, and screening patients around the clock. Clinical staff trained on the trial must be present in the clinic or emergency room at all times to avoid missing any potential patients. Additionally, an investigator should be either onsite or readily available on call to provide immediate support and oversight.

By tailoring our recruitment strategies to the specific needs of chronic and acute conditions, we can significantly improve patient enrollment and enhance the overall success of clinical studies.

Adaptation of Study Documents

As your clinical trials expand across borders, the need for accurately adapted and translated study documents becomes paramount. SCIRENT excels in adapting and translating study documents, including study synopses, Informed Consent Forms (ICF) according to regional specifics, and patient questionnaires. Our team of experts ensures that all materials are customized and localized for different regions, adhering to local cultural sensitivities and regulatory standards. This meticulous process guarantees that your clinical trials are conducted seamlessly worldwide, maintaining the highest levels of accuracy and compliance.

Financial Administration

At SCIRENT, we understand the importance of efficient financial administration in clinical trials, particularly concerning site and investigator payments. Our services are tailored to offer streamlined and transparent handling of financial matters, ensuring timely and accurate compensation for European sites. Our expertise alleviates the administrative burden, allowing you to focus on the critical aspects of your clinical research.

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