At eHealth Science, we offer a range of services to our clients, including regulatory affairs, clinical operations management, research design and analysis, project management, quality assurance, regulatory affairs support, clinical site assessment, data management including data collection (eCRFs), data entry (EDC), data processing (EDS/DME), data analysis as well as reporting. Our team of experts ensures that we provide customized solutions to each of our clients, depending on their specific needs.

Regulatory Affairs: Our team provides regulatory support to clients to ensure that they meet the requirements of regulatory agencies. We have a deep understanding of the regulatory process, and our experts provide guidance on regulatory strategy, preparation of regulatory submissions, and interactions with regulatory authorities.

Clinical Operations Management: Our team is well-equipped to handle all aspects of clinical operations management, from trial design to study execution. We have expertise in conducting trials across various therapeutic areas and have experience in managing trials of varying complexity.

Research Design and Analysis: We help our clients design studies that generate high-quality data that can be used to support regulatory submissions, market access, and reimbursement. Our team has experience in designing studies across various therapeutic areas and has expertise in various study designs, including randomized controlled trials, observational studies, and real-world evidence studies.

Project Management: We have a team of project managers who oversee all aspects of project execution, ensuring that projects are completed on time and within budget. Our project managers work closely with our clients to ensure that project goals and timelines are met.

Manufacturing Engineering: We provide expertise in manufacturing engineering to ensure that our clients' products are manufactured in compliance with regulatory requirements. Our team has experience in designing manufacturing processes, developing specifications, and validating manufacturing processes.

Facilities Planning & Procurement: Our team can assist clients in planning and procuring facilities for manufacturing and conducting clinical trials. We have experience in evaluating facilities for compliance with regulatory requirements and can assist clients in selecting appropriate facilities.

Supply Chain Management: Our team provides expertise in supply chain management to ensure that our clients' products are manufactured, stored, and distributed in compliance with regulatory requirements. We have experience in managing the supply chain for medical devices, IVDs, and digital health solutions.

Quality Assurance: We provide expertise in quality assurance to ensure that our clients' products are manufactured and tested in compliance with regulatory requirements. Our team has experience in developing quality management systems, conducting audits, and providing guidance on compliance with regulatory requirements.

Clinical Site Assessment: We can assist clients in evaluating clinical trial sites for compliance with regulatory requirements. Our team has experience in evaluating sites for clinical trials of various therapeutic areas.

Data Management: Our team provides expertise in data management, including data collection, entry, processing, analysis, and reporting. We have experience in managing data for clinical trials, real-world evidence studies, and observational studies.

Our expertise in regulatory affairs and clinical research extends to medical devices and in vitro diagnostics (IVDs). We help clients navigate the complex regulatory landscape for medical devices and IVDs, ensuring compliance with regulatory requirements and facilitating market access. Our team has experience in preparing regulatory submissions for various classes of medical devices and IVDs, including Class I, II, and III devices, as well as companion diagnostics.
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We provide support throughout the product development lifecycle, including product design and development, clinical trial design and execution, and postmarket surveillance. Our team is well-equipped to handle all aspects of medical device and IVD development, including risk management, usability engineering, and product testing. We work closely with our clients to ensure that their products are safe, effective, and meet the needs of patients and healthcare providers.

The field of digital health is rapidly evolving, and we at eHealth Science are at the forefront of this evolution. Our team has expertise in developing and evaluating digital health solutions, including mobile health apps, telemedicine platforms, and remote monitoring devices. We help clients navigate the complex regulatory landscape for digital health solutions, ensuring compliance with regulatory requirements and facilitating market access.
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We work closely with clients to develop evidence to support the safety and effectiveness of their digital health solutions. Our team has experience in conducting real-world evidence studies, evaluating the usability of digital health solutions, and developing health economic models to support market access and reimbursement. We also provide guidance on data privacy and security, ensuring that our clients' digital health solutions are compliant with regulatory requirements.

In addition to our services for eHealth Science clients, we also act as a Contract Research Organization (CRO) for portfolio companies and third parties. As a CRO, we provide a range of services, including study design, protocol development, site selection, project management, and data management. Our team has experience in managing trials across various therapeutic areas, including cardiology, oncology, and neurology. We work closely with clients to ensure that their trials are conducted efficiently and effectively, with a focus on data quality and patient safety. Our team has experience in managing trials of varying complexity, including global trials with multiple sites and complex protocol requirements. We also provide guidance on regulatory compliance, ensuring that trials are conducted in compliance with regulatory requirements.

At eHealth Science, we are dedicated to providing high-quality evidence to support the implementation of medical devices, in vitro diagnostics, and digital health solutions into healthcare systems around the globe. Our team of experts has extensive experience in regulatory affairs and clinical research, and we provide customized solutions to each of our clients, depending on their specific needs. We are committed to ensuring that our clients' products are safe, effective, and meet the needs of patients and healthcare providers. Whether you are a startup, SME, or Fortune 500 company, we are here to support your commercialization efforts and help you navigate the complex regulatory landscape.