Services

Our services

All our services benefit from the cooperation with other companies of Hippocrates Group. Thanks to such interaction we can provide ePRO solutions, develop IT evaluation algorithms and computer-based

clinometric supports, get pharmacogenetic insights, carry out genetic screening of subpopulations and international trial expansions.

Our experience

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PHASE I/IV

We can offer our clients the best support in all phases of clinical research:

> Successful Phase I trials with particular expertise in design, methodology and statistical considerations for Phase I generally involving diagnosed patients.

> We have a huge expertise in Phase II trials, including helping Sponsors with proof of concept studies.

> Thanks to the full complete services offered, we are able to manage a complete project planning to build clinical trials from the early stages, taking into account risk strategies, time and budget planning, optimizing the performance of the management to respect all milestones.

> Phase IV & Post-Market. We have the required experience to carry out post-market and observational studies across all therapeutic areas.

NIS/PASS

Non-interventional studies (NIS) are an essential part of the clinical development program of new drugs. Non-interventional trials – which include post-marketing surveillance studies (PMS), post- authorization safety studies (PASS), cohort studies, case-control studies, and register studies – are crucial to integrate the information available at the time of the drug authorization with additional information on safety and, in some cases, also on the efficacy of medicinal products for human use authorized in accordance with Regulation (EC) no. 726/2004.

We have an huge expertise in NIS/PASS both on drugs and MD, conducted in more than 19600 sites and with almost 650.000 pts enrolled. We turn out to be the best trial best recruiters at European and international level, often competing with world leading players.

NUTRACEUTICAL

Nutraceuticals are natural bioactive, chemical compounds that have health-promoting, disease-preventing, or medicinal properties. They are a group of products that are more than food but less than pharmaceuticals but, even if there isn’t an internationally accepted definition of these products, from a safety point of view nutraceuticals are trusted products even if they are not approved by authorities like pharmaceuticals. Nutraceutical trial design presents several unique challenges for researchers and we support manufacturers to develop unique claims to use in marketing efforts.

We have a huge expertise in nutraceuticals clinical studies and the results originating from our studies, supporting their effectiveness as well as their general safety, have also been published on International Journals.

DERMOCOSMETIC

Also, dermocosmetics have to satisfy severe standards in terms of safety and efficacy especially if they are addressed to a paediatric population. Moreover, any claims a Company wishes to make for its product must have robust documentary evidence.

For this reason, this kind of product, which is used in a variety of skin disorders, is realized in cooperation with specialists such as dermatologists, paediatricians, and ophthalmologists and their characteristics are supported by results obtained from clinical studies.

We are able to assist our clients in this new branch of dermatology which is a valid source of innovative products alternative to drugs.

MD and SaMD

Over the years, we have been conducting many clinical trials on Medical Devices of all classes, both for pre-market and post-market studies, in most Therapeutic Areas.

With the new EU Regulation (EU 2017/745) enforceable beginning 26 May 2021 we are proceeding in the same way with innovative and dedicated solutions in a constantly growing market; in order to perform pre-market clinical trial to support the CE marking of medical devices and conducting PMCF (Post-market clinical Follow-up) also for SaMD.

A solution for every stage of the project

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Trial feasibility studies

Or drug development project are carried out quickly thanks to: an accurate literature research; evaluation of regulatory issues; anonymous consultation with our Key Opinion Leaders and with clinical excellence centres; submission of questionnaires to experimental centres; writing a research protocol; hearings with regulatory authorities in every country.

Clinical monitoring

Is performed following clinical needs, Sponsor’s procedures, enrollment performance and data quality. We are frequently positioned as the best recruiters at the European level in competitive and noncompetitive studies. We developed specific Standard Monitoring Procedures to perform, with a higher quality level, remote monitoring according to the GCP and GDPR rules.

Clinical sites selection

According to criteria such as the outcome of literature review, speed of activation of the site in ethical and administrative terms, human resources available and our previous experience, which, after more than 25 years of activity, cover all therapeutic areas in drugs, medical devices, food supplements and cosmetics.

Regulatory affairs

We offer regulatory and pre-IND/IND meeting consultation services.

Activation of sites

Thanks to a careful and trustworthy feasibility process and the experience gained in the negotiation of contracts and budgets with the sites’ administrations, we are able to offer the fastest and most efficient activation service for sites activation even remotely wherever necessary.

Project management

Our Project Management focuses on achieving scientific and clinical trial objectives, relying on the protocol-specific expertise in the relevant therapeutic area of every research team, sharing Sponsor’s KPIs (often sharing those required by head office to its subsidiary) and carefully evaluating clinical sites’ issues related to the research project.

Long term archive

HR is Leader in Europe in the Long Term Archiving of documents produced by clinical sites related to trials.

Pharmaco- vigilance

HR is accredited by EudraVigilance as a service provider for ICSRs data collection, medical reviews, literature reviews, global services, training, etc.

Data management and statistic

Thanks to a qualified partnership with stable vendors, our statistic unit could provide full statistical services including: SAS programming (ADaM dataset), CDISC and SDTM standards.

Integrated marketing support

We manage press conferences, observational and spontaneous trials, CME events, we draw up information material and brochures in support of the product.

Creation and management of registries

HR has contributed to the creation and management of a number of National Registers for patients with IBD, Lacrimal Dysfunction, Glaucoma, Migraine, Thromboembolism and more.

Drafting of research protocol & CRF

In accordance with study-specific needs, in compliance with ethical requirements and legislation in force, considering physician and patient compliance.

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

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