eighteen years hippocrates sponsor giqar · hippocrates research hippocrates research is a...

EIGHTEEN YEARSHIPPOCRATESSPONSOR GIQAR

We’ve come of age.

Company profile

Who we are02

Our mission isCustomer Satisfaction

If Quality inspires your logic, Customer Satisfaction plays a key role in setting priorities and company policies. Starting from our Sponsors’ needs and relying on a tailored approach we integrate Key Performance Indicators (KPIs) in our workflow management and data management systems in order to completely adapt our structure to the objectives agreed upon with our Sponsors. We have been on the market since 1995 and are still willing to learn from young people because we believe in helping genuine talents to blossom.

Passion and enthusiasm for our work are our two guiding principles.

Hippocrates Research

Hippocrates Research is a full-service Contract

Research Organization



03

We have been in the futurefor twenty years

Understanding our Sponsors’ vision is our starting point and from there we get underway from the selection and identification of a new molecular entity to feasibility and development studies, from Phase I to Phase IV clinical trials. We operate in 16 countries and 3 continents.

Here’s why you should choose us

ACCRedited by:ema

EUdraVIgIlancE

eNCePP databaseEUroPEan nEtWork of cEntrES

for PharmacoEPIdEmIlogy and PharmacoVIgIlancE

aiFaagEnzIa ItalIana dEl farmaco

PrESSo Il rEgIStrocro – USEroSSc

isO 9001:2015CeRtiFied



Who we are

United we… research

04

At Hippocrates Research we are in a position to accompany our Sponsors from Phase I studies to product launch also thanks to other companies belonging to Hippocrates Holding.

Hippocrates Sintech is an information technology company focusing on communication in the healthcare and pharmaceutical industry.

Hippocrates Pharma Genetics, is a company operating in the pharmacogenetics and pharmacogenomics fields.

PSN Research (US full-service CRO) enables us to be both national and international players.

Nyali Swiss, a management consulting company based in Lugano able to support our Customer in the validation and implementation of market and organizational strategies, to improve the overall performance of its own business.

We expand perspectives

Membership:

simeFSocIEtà ItalIana dI mEdIcIna

farmacEUtIca

GiQaRgrUPPo ItalIano QUalIty aSSUrancE nElla rIcErca

rESPonSabIlE

sismeCSocIEtà ItalIana dI StatIStIca

mEdIca Ed EPIdEmIologIa

sOCiety FOR CliNiCaldata maNaGemeNt

GlObal COmPaCtOF UNited NatiON ORGaNizatiON


Il Gruppo Hippocrates:





Who we are

05

Are carried out quicklythanks to: accurate literature research

evaluation of regulatory issues

anonymous consultation with our Key Opinion Leaders and with clinical excellence centers

submission of questionnaire to experimental centers

drawing up a research protocol

hearings with regulatory authorities in every European country

Services

data Quality



Feasibility studiesof clinical trial or

drug development project

06

drawing up the research Protocol and crfin accordance with study-specific needs, in compliance with ethical requirements and legislation in force, considering physician and patient compliance.

clinical sites selectionAccording to criteria such as outcome of literature review, speed of activation of the site in ethical and administrative terms, human resources available, our previous experience, which, after 20 years of activity, cover all therapeutic areas in drugs, medical devices, food supplements and cosmetics.

clinical monitoringWe are keeping sensitive to clinical needs, Sponsor’s procedures, enrollment performance and data quality. We often turn out to be best recruiters at European level in competitive and non-competitive studies.

our Project managementfocuses 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.

data management and drawing upthe final reportare in line with the procedural requirements of national and international regulations as well as data quality and the sharing of Sponsor’s objectives.

all these services benefit from the interaction 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.

Services

All servicesare tailored on our

Sponsors’ needs



07

Key strengths:

Post-Authorisation Safety Studies (PASS)

“First-in-Man” studies

Clinical trials with GPs

Creation and Management of Registries

Medical Device Development

Integrated Marketing Support

Pharmacovigilance

Strategic Partnership

Long Term Archiving®

Hearings with Regulatory Authorities

Accreditation of Phase I Centers

exclusive services

We provide youwith excellence



08 exclusive servicesEIGHTEEN YEARSHIPPOCRATESSPONSOR GIQAR


Post-authorisation Safety Studies (PaSS):we turn out to be trial best recruiters at European and international level, often competing with world leading players.

“first in man” studies:HR has proven experience in managing operative and scientific issues of trials implying “first in man” new chemical entities.

clinical trials with gPs:a network of 400 General Practitioners with experience in interventional, regulatory and non-regulatory, observational and epidemiologic trials.

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.

medical device development:We have been involved, for years, in the clinical development of Medical Devices of all classes under European Directive a 2007/47/CE.

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

Pharmacovigilance:HR is accredited by EudraVigilance. It provides services such as medical reviews, ICRSS data collection, literature reviews, global services, training, etc.

Strategic Partnership:a broader definition of services includes communication, regulatory, and archiving competences which have been developed with Partners playing leading roles in their fields.

long term archiving®: HR is a European leader in long term archiving of clinical sites’ trial documents.

hearings with regulatory authorities:HR promotes and manages hearings and assists Sponsor in hearings with regulatory Authorities.

accreditation of Phase I centers:Support for obtaining accreditation and compliance with the requirements for public health facilities, which carry out phase 1 trials, as set out in AIFA determines June 19, 2015.

09

Customer Satisfactionis the key word on our resumé

Customer Portfolio

A team full of passion for its work is the reason why our customers keep

recommending us



10

A competitiveattitude

Open-ended contract staffNo freelance staff, low staff turnover, average length of service: 7 years.

Financial indexesFinancially reliable according to Basel 2.Bank references and certification available on request.

Professional liability insurance Limit up to 10.000.000,00 €.

e-CRF In accordance with the standards laid down in21 CFR PART 11 FDA

training and communicationOrganization of events, seminars and congresses for trial support.

Pharmacovigilance Accredited by EudraVigilance (EMA).



Competitive edge

via XX Settembre 30/12 - 16121 Genova, ItalyTel. +39 010-545481 Fax 010-8932548/010-8936856

e-mail: [email protected] e P.IVA: 02853730279

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www.hippocrates-research.it

Wherever the art of Medicine is loved, there is also a love of Humanity.

(Hippocrates, c. 460-370 bC)



eighteen years hippocrates sponsor giqar · hippocrates research hippocrates research is a...

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