All our services benefit from the cooperation with other companies of Hippocrates Group. Thanks to such interaction we are in a position to draw up effective e-CRFs and iPAD-supported clinical diaries, develop IT evaluation algorithms and computer-based clinimetric supports, get pharmacogenetic insights, carry out genetic screening of subpopulations and international trial expansions.
- PHASE I/IV
- MD (Medical Device Development )
We can offer to our clients the best support in all phase of clinical researches:
- Successful Phase I trials with particular expertise in design, methodology and statistical considerations for Phase I generally involve diagnosed patients.
- We have an huge expertise in Phase II trials, including helping Sponsors with proof of concept studies.
- Thanks to complete services offered, we are able to manage a complete project planning to build clinical trials from the early stages, taking into the 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.
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 1600 sites and with almost 50.000 pts enrolled. We turn out to be trial best recruiters at European and international level, often competing with world leading players.
Over the years, we have been conducting in Italy 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) studies.
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 an huge expertise in nutraceuticals clinical studies and the results originating from our studies, supporting their effectiveness as well as their general safety, have been also published on International Journals.
Also dermocosmetics have to satisfy severe standards in term 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, 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.
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 questionnaire to experimental centres; writing a research protocol; hearings with regulatory authorities in every country.
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.
Clinical sites selection
According to criteria such as 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.
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 centers conducted in the center or even remotely wherever necessary
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 research project.
Is performed followingclinical needs, Sponsor’s procedures, enrollment performance and data quality. We frequently position as best recruiters at European level in competitive and noncompetitive studies. We developed specific Standard Monitoring Procedures to perform, with the higher quality level, remote monitoring accordingly to the GCP and GDPR rules.
Hippocrates Research is accredited by EudraVigilance as a service provider for ICRSS data collection, medical reviews, literature reviews, global services, training, etc.
Data management and statistic
Our statistic unit, also thanks to a qualified partnership with stable vendors, could provide Full statistical services including: SAS programming (ADaM dataset), CDISC and SDTM standards.
Are in line with the procedural requirements of national and international regulations as well as data quality and the sharing of Sponsor’s objectives
Long term archiving
Hippocrates Research is Leader in Europe in the Long Term Archiving of documents produced by clinical sites related to trials.
Integrated marketing support
We manage press conferences, observational and spontaneous trials, CME events, we draw up information material and brochures in support of 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.