Ispharm s.r.l.
Via Dorati, 117 55100 LUCCA
Tel / Fax + 39 0583 56899
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Services
Ispharm (s.r.l.) is a leading Italian Contract Research Organisation (CRO), specialised in providing quality service to the Italian pharmaceutical industry and any correlated industry in the following areas :
1. clinical research & pharmaceutical research
2. registration procedures
3. development
4. scientific communication
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The firm is composed of specialists who have been working in this field for several years an who have previous experience in the pharmaceutical industry and CROs. Physicians, pharmacologists, research chemists, biochemists, chemists, biologists, statisticians, computer scientists and graphic designers, with profound knowledge of the problems connected with the various phases of clinical and pharmacological research, of registration and development, of data management and of scientific reports, work in cooperation with ISPharm.
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ISPharm owns a particularly interesting sector, which is institutionally oriented to the management of problems related to drug legislation and to relations with the Regulatory Authorities.
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The firm is able to offer a wide range of services in the pharmaceutical field from an integrated development of pre-clinical and clinical study planning to the presentation of the scientific data, which can be used either for registration, information or promotion.
The activities of the firm extend to the sector of medical devices. The various services can be offered in one single package deal, or managed individually according to the objectives; always with the maximum flexibility regarding the customer's needs.
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ISPharm is helped by direct experience in the study of :
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- ACE-inhibitors
- Anxiolytics
- Platelet anti-aggregants
- Antibiotics
- Antidepressants
- Steroids
- NSAIDS
- Anti-asthmatics
- Antihypertensives
- Antimycotics
- Antispastics
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- Anti-ulcers
- Bronchodilators
- Chondroprotectors
- Oral hypoglycaemic drugs
- Hypolipidaemic drugs
- Profibrinolytic agents
- Thrombolytics
- Vaccines
- Vasoprotectors
- Vitamins
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Ten years experience acquired through cooperation with numerous national and international pharmaceutical companies, with thousands of patients observed
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(*) The authorization has been given by the local ASL (Azienda Sanitaria Locale), “Azienda USL n° 2, Lucca) with doc. Prot. N. 94/1/7.3.5.1 of 16th February 1999 released in conformity with the Health Department Order of the 19th March 1998 (G.U. n 122 of 28/05/1998) and with the Health Department Order of 7th October 1998 ( G.U. n. 274 of 23/11/1998). The Qualification has been registered at the Ministry of Health Department for evaluation of medicines and Pharmacovigilance – Office II Clinical Experimentations with letter dated 22/02/1999.
(**)The clinical research of bioequivalence and bioavailability are conducted in conformity with the EEC guideline “Investigation of bioequivalence and bioavailability” (Discipline related to drugs in the European Community, Volume III, supplement 2 of May 1992) and “Note for guidance on the investigation bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98 draft).
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