According to the directive 2000/38/CE, Pharmacovigilance establishes major and heavy charges and responsibilities for the Pharmaceutical Industry.
Hippocrates Research has studied an innovative package of economical and effective Services.
Hippocrates Research offers different kinds of Pharmacovigilance solutions, one independent from the other, able to cover a wide range of requirements, maintaining a very competitive price.
“Entry level" Package
A customized solution that enables you to enter your own Pharmacovigilance database without using other modules purchased by the Client
A number of ADR lower than 6-8 per month allows Pharmaceutical Companies to obtain really competitive and economical options.
Entry Level includes user registration in the EudraVigilance System and the introduction of his own products in the Data Base.
This basic package provides, in addition to database management and maintenance, reports production, periodic back-up, a help-desk service,
Entry Level allows complete Pharmacovigilance management, from data entry to data transmission to EudraVigilance; it is not inclusive of the services listed below.
Warning Data Collection
The Entry Level package can be integrated with the single case collection activity for clinical data, once the source (ex:. Welfare facilities, G.P.) has been notified by the Sponsor or, the source has made direct contact with Hippocrates Research.
The activities of this package include also getting in touch with the source of the notification, data collection data cleaning and MedDRA encoding.
Medical advice on the events and related reporting
The drug adverse events data has to be reviewed by a qualified Physician to place them in the correct clinical context and to report them properly.
This package includes the evaluation, performed by Hippocrates medical staff, of the events nature and of internal and external reports production. The evaluation of scientific literature related to the event and the management of cases of pregnancy of patients participating in clinical trials are included.
Scientific literature monitoring
Regulations establish that adverse events reported by international scientific literature are also to be notified to the Pharmacovigilance system.
This module features a periodical monitoring of clinical and toxicological publications related to the products included in the Sponsor’s price list.
24-hour-availability
For some kinds of clinical trials, of not very well known products or blind studies, Investigators are often required to contact the Sponsor in case of emergency (access to the randomization codes, products information).
This package guarantees a 24-hours-availability, 365 days/year with a telephone service (information supplying), within one hour during office time, within 12 hours out of office time , during working-days and within 24 hours during non-working days.
Training
This package provides a periodical update on the new Pharmacovigilance regulations, and “field force” recurrent training with production of documents and teaching materials.
Pharmacovigilance full responsibility assumption
Taking of responsibility for the Pharmacovigilance Manager’s functions. This package includes a general feasibility study for each Pharmaceutical Company.
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