Services
Our services
All our services are enhanced through close collaboration with the other companies within the Hippocrates Group. This integrated ecosystem enables Hippocrates Research to deliver innovative, technology-driven solutions across the clinical development continuum.
Through this collaboration, we provide ePRO solutions, develop AI-powered platforms to support clinical studies, design advanced IT evaluation algorithms and computer-based clinometric tools, and generate pharmacogenetic insights, including genetic screening of targeted subpopulations.
In addition, our Group structure supports international trial expansion, allowing sponsors to scale their clinical programs efficiently across multiple geographies.
Our experience
Hippocrates Research provides comprehensive, end-to-end support across all phases of clinical research, combining scientific expertise, operational excellence, and strategic project management.
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PHASE I/IV
HR supports sponsors throughout the full clinical development lifecycle, from early clinical phases to post-marketing activities:
- Proven expertise in the design, methodology, and statistical planning of Phase I trials, with particular focus on studies involving diagnosed patients. Extensive experience in Phase II trials, including support for proof-of-concept studies, helping sponsors make informed go/no-go decisions. Thanks to a full-service approach, HR manages complete clinical development plans from early-stage design through execution, integrating risk mitigation strategies, timeline optimization, and budget control to ensure milestone achievement. Phase IV & Post-Market. Strong capabilities in post-marketing and observational studies across all therapeutic areas.
NIS/PASS
Non-interventional studies are a critical component of modern clinical development, supporting the generation of real-world evidence to complement data obtained at the time of marketing authorization.
HR has extensive experience in NIS and PASS for both drugs and medical devices, including post-marketing surveillance, post-authorization safety studies, cohort and case-control studies, and registries.
With over 3000 sites and nearly 70000 patients enrolled, HR is recognized as one of the leading trial recruiters at European and international level, consistently competing with global CROs. Medical Devices & Software as a Medical Device (MD / SaMD)
Hippocrates Research has conducted numerous clinical investigations on medical devices of all risk classes, supporting both pre-market and post-market studies across a wide range of therapeutic areas.
In line with the EU Medical Device Regulation (MDR – Regulation (EU) 2017/745), HR provides innovative and dedicated solutions to support:
- Pre-market clinical investigations for CE marking
- Post-Market Clinical Follow-Up (PMCF) activities
- Clinical evaluation of Software as a Medical Device (SaMD)
NUTRACEUTICAL
Nutraceuticals represent a rapidly growing area between food and pharmaceuticals, requiring robust clinical evidence to support safety, efficacy, and product claims.
HR has extensive experience in the design and execution of nutraceutical clinical studies, supporting manufacturers in overcoming the unique methodological challenges of this field and in developing credible, market-oriented claims.
Results from HR-supported studies have been published in international scientific journals, confirming both effectiveness and safety.
DERMOCOSMETIC
Dermocosmetic products must meet stringent safety and efficacy standards, particularly when intended for sensitive populations such as paediatric patients.
Hippocrates Research supports companies in this innovative branch of dermatology through clinical studies conducted in collaboration with dermatologists, paediatricians, and ophthalmologists, generating robust evidence to substantiate product claims.
HR assists clients in developing innovative, drug-alternative dermocosmetic solutions, supported by high-quality clinical data.
Medical Devices & Software as a Medical Device (MD / SaMD)
Hippocrates Research has conducted numerous clinical investigations on medical devices of all risk classes, supporting both pre-market and post-market studies across a wide range of therapeutic areas.
In line with the EU Medical Device Regulation (MDR – Regulation (EU) 2017/745), HR provides innovative and dedicated solutions to support:
- Pre-market clinical investigations for CE marking
- Post-Market Clinical Follow-Up (PMCF) activities
- Clinical evaluation of Software as a Medical Device (SaMD)
A solution for every stage of the project
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Trial feasibility studies
Trial feasibility studies are conducted efficiently through accurate literature research, evaluation of regulatory requirements, anonymous consultation with Key Opinion Leaders and clinical excellence centres, submission of feasibility questionnaires to investigational sites, drafting of research protocols, and scientific and regulatory interactions with competent authorities in each country.
Clinical monitoring
Clinical monitoring is performed according to clinical needs, sponsor procedures, enrolment performance, and data quality requirements. Hippocrates Research is frequently recognized as one of the best recruiters at European level in both competitive and non-competitive studies. Specific Standard Monitoring Procedures have been developed to ensure high-quality remote monitoring activities in full compliance with GCP and GDPR requirements.
Clinical sites selection
Clinical site selection is based on criteria such as the results of literature reviews, the speed of site activation in terms of ethical and administrative procedures, the availability of human resources, and HR’s extensive experience. After more than 30 years of activity, this experience spans all therapeutic areas and study types, including drugs, medical devices, food supplements, and cosmetics.
Regulatory affairs
Regulatory affairs services include regulatory consultancy and support for pre-IND and IND meetings with competent authorities.
Activation of sites
Site activation is supported by a reliable feasibility process and extensive experience in contract and budget negotiations with site administrations, allowing Hippocrates Research to provide fast and efficient site activation services, including remote activation whenever required.
Project management
Project management activities focus on achieving scientific and clinical trial objectives, leveraging protocol-specific expertise within dedicated research teams. This approach includes alignment with sponsor key performance indicators, often shared with headquarters, and careful evaluation of site-related issues throughout the project lifecycle.
Long term archiving
Long-term archiving services position Hippocrates Research as a European leader in the secure archiving of clinical trial documentation produced by investigational sites.
Pharmacovigilance
Pharmacovigilance activities are provided through a qualified and experienced partner. These services include ICSR data collection and management, medical review, literature review, global pharmacovigilance support, and dedicated training, ensuring full compliance with applicable regulatory requirements.
Data management and statistic
Data management activities are performed internally by Hippocrates Research through dedicated and experienced teams, ensuring full control over data quality, consistency, and compliance throughout the study lifecycle. Statistical services are delivered through qualified and long-standing partnerships, enabling the provision of full statistical support, including SAS programming, ADaM datasets, and compliance with CDISC and SDTM standards.
Drafting of research protocol & CRFs
Drafting of research protocols and CRFs is performed in line with study-specific requirements and in full compliance with applicable ethical standards and current legislation, while also taking into account both patient and investigator compliance throughout the study.
Integrated marketing support
Integrated marketing support includes the management of press conferences, observational and spontaneous studies, CME events, and the development of informational materials and brochures in support of products.
Creation and management of registries
Hippocrates Research has extensive experience in the creation and management of national patient registries, contributing to registries in areas such as inflammatory bowel disease, lacrimal dysfunction, glaucoma, migraine, thromboembolism, and other conditions, supporting the generation of real-world evidence.
Final report and study publication
Final reports and study publications are prepared in accordance with national and international regulatory requirements, ensuring high data quality and alignment with sponsor objectives, and supporting sponsors through to the completion of final documentation and scientific publications.
Scientific communication & information
Scientific communication and integrated marketing services include advisory boards and expert opinion meetings, medical information activities such as bibliographic research and data analysis, dissemination and training initiatives, medical writing and editorial support, and the development of educational materials and scientific publications. HR also supports sponsors through integrated marketing activities, including press conferences, CME events, and the development of informational and promotional materials.
Final report and study publication
In line with the procedural requirements of national and international regulations as well as data quality and the sharing of the Sponsor’s objectives, we can assist till drafting of final report and publications if needed.