Frequently Asked Questions

Yes, through an API, it is possible to link the ResearchManager Clinical Research Suite (CRS) with various external systems, including financial, HR, and EMR systems.

The CRS supports a wide range of clinical research, including drug studies (Phase I-IV), device studies, biological and non-biological intervention studies, observational studies, registrations, pivotal studies, pilot studies, and Post-Market Surveillance (PMS).

The ResearchManager Clinical Research Suite is used by various sectors and organizations, including CROs, (academic) hospitals, MedTech, BioTech, Pharma, Universities, and Ethical Committees. Supporting this diverse user base helps promote accurate data collection, regulatory compliance, and accelerates research processes, ultimately advancing the development of new treatments and therapies.

The Clinical Research Suite (CRS) offers several advantages for clinical research, such as improved data management, precise monitoring, and shortened timelines for clinical trials. It streamlines processes and enhances the overall research experience. Its unique flexibility allows easy adaptations to individual processes and studies without the need for programming knowledge, making it a valuable and adaptable tool for clinical research management.

The CRS serves clients globally, including Europe, the US, Australia, Africa, and Asia. Collaborations have been established with various companies and organizations worldwide.

The CRS is an integrated system that categorizes various modules into Clinical Data Management (EDC, ePRO, RTSM, eConsent) and Clinical Operations (CTMS, eTMF, RIMS, and LIMS). These modules work together to provide a comprehensive management system for clinical trials. They can also be used separately to meet specific user needs. Using the CRS allows for a secure and efficient platform at any phase of the Clinical Trial Journey.

The CRS enhances data collection efficiency by transitioning from paper-based processes to digital data collection and management. This reduces errors, speeds up data collection, improves data quality, and enables real-time analysis and decision-making. On the operational side, the CRS streamlines operational processes, allowing research teams to better plan, monitor, and manage clinical trials throughout their duration.

The platform provides control mechanisms such as automatic checks and validations and supports real-time data monitoring to ensure data quality.

Yes, the CRS offers researchers real-time access to data, enabling them to actively monitor ongoing studies and conduct data analyses as the research progresses.

Yes, the data management tool EDC within the CRS supports integration with wearables and smart devices for data collection, such as fitness trackers and other health monitoring equipment. It allows researchers to directly collect and integrate data from various health monitoring devices into clinical research, providing a more comprehensive view of patients and their health, strengthening the accuracy and depth of the collected data.

ResearchManager holds the ISO 27001 certification and has a Business Continuity Plan according to this certification. Optionally, an Escrow agreement can be arranged.

The CRS adheres to stringent security standards such as encryption, access control, audit trails, and compliance with global privacy regulations like HIPAA, GDPR, ISO 14155_2020 compliance, and 21 CFR PART 11 to ensure the safety and privacy of sensitive patient data.

The CRS complies with internationally recognized regulations, including ISO 27001 for data security, NEN7510 for healthcare information security, ISO 14155 compliance for clinical research with medical devices, HIPAA for healthcare data protection, 21 CFR PART 11 for electronic data and signatures, and GDPR for data protection in the EU.

Before the project, a kickoff session is arranged to discuss goals and expectations. This session marks the beginning of a customized implementation process for clients. The process begins with phase 0: project initiation, where the functional design and project plan are approved. Then, subsequent phases 1, 2, and 3 follow for further adjustments. After evaluation in the Go/No Go assessment, a monitoring phase ensues for any additional modifications. The entire process is designed to ensure that the custom implementation meets the unique demands and wishes of the customer.

Absolutely, ResearchManager has over 10 years of experience in implementing various organizations, from CROs to academic hospitals. Numerous successful custom implementations have been completed, tailoring the CRS to specific requirements and processes.

ResearchManager in the Clinical Research Suite (CRS) offers extensive customization for users. From forms and workflows to reports and Trial Dashboards, the platform is designed with a modular structure so it can be tailored to specific requirements and processes.

Yes, at ResearchManager, standard support is included in an SLA. We’re also always ready to make adjustments for specific needs in a customized SLA.

Yes, alongside the CRS, ResearchManager offers additional services such as consultancy and training. This includes data migrations, functional management, and customized adaptations.

Yes, global support is available. Our standard support is available on weekdays from 8:00 to 17:00 (CET) according to our standard SLA. Additionally, ResearchManager offers more comprehensive tailored support (e.g. 24/7) based on specific needs and requirements, which requires customized arrangements.

Yes, the CRS is entirely based on the Software as a Service (SaaS) model. The platform does not require local installation and offers immediate access via web browsers, providing users worldwide with efficiency and flexibility.

Regulatory Information Management System (RIMS) is widely used in the clinical research sector by various stakeholders, including Contract Research Organizations (CROs), Institutional Review Boards (IRBs), Ethical Committees (ECs), biotechnology companies, pharmaceutical organizations, and academic research institutions. These systems are an integral part of managing regulatory documentation and help streamline processes to comply with regulatory standards in clinical research.

The Regulatory Information Management System (RIMS) is essential in clinical trials to comply with strict regulatory standards. The system provides streamlined storage, management, and reporting of all regulatory documents required for clinical trials. This includes managing protocols, research reports, approvals, and other necessary documentation for regulatory compliance and audits.

ResearchManager LIMS automates and manages laboratory processes, making it more efficient to track samples, conduct tests, and analyze data. This leads to better laboratory management, increased accuracy, improved data integrity, and timely reporting of results.

Yes, there is integration between Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF). This integration streamlines the exchange of data and documents between systems, enhancing the management of essential documentation and regulatory requirements for clinical research.

ResearchManager eTMF, a tool within the Clinical Research Suite (CRS), automates the management of trial master files, making it easy for research teams to store, organize, track, and validate documents. The system promotes compliance through centralized, organized, and secure storage of essential documents, supporting inspection and audit preparation while readying the Investigator Site File (ISF). It also includes an integrated and validated eSign module for immediate signatures.

ResearchManager CTMS is highly adaptable, allowing customers to tailor functionalities to their specific needs. This includes the ability to customize reports, create customized dashboards, and configure workflows, enabling research teams to create a tailored solution that meets their unique requirements.

ResearchManager CTMS enhances operational efficiency by offering comprehensive functionalities such as managing workflows, approval processes, report generation, communication, and more. These features optimize project planning, resource management, and patient monitoring, increasing the operational pace and overall efficiency of clinical research.

ResearchManager RTSM, a tool within the Clinical Research Suite (CRS), is suitable for Randomized Controlled Trials (RCTs). RTSM encompasses powerful tools for randomization and inventory management. This feature simplifies the complexity of the inventory chain in clinical research and ensures strict adherence to protocols. Accurately delivering treatments contributes to the safety and integrity of the studies.

ResearchManager eConsent, a tool within the Clinical Research Suite (CRS), focuses on enhancing participants’ experience by providing them with interactive and understandable information about the research and consent procedures. This makes it easier for participants to engage in studies by providing clear and transparent consent, resulting in better participant engagement and an efficient consent process, whether on-site or remotely via the web, phone, or tablet.

ResearchManager ePRO, a tool within the Clinical Research Suite (CRS), enables patients to input research data from any location, whether through web, phone, or tablet. This enhances patient participation willingness and maximizes the quality of data recording by providing flexibility in collecting the right data at the right time, supported by schedules for automated data collection.

ResearchManager EDC, a tool within the Clinical Research Suite (CRS), provides benefits for data collection, such as real-time data collection, advanced data quality controls, and comprehensive reporting capabilities. These features enable researchers to gain in-depth insights, contributing to improved decision-making throughout the research process, including support for multicenter studies across multiple locations.