Ing. Helmut Schütz

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Consultancy Services for Bio­equi­va­lence and Bio­avail­abi­lity Studies

BEBAC specializes in providing biostatistical services, con­trac­tor selection and supervision. We have wide ex­pe­rience with biostatistics, pharmaco­kinetics, and bio­analytics.

Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.

We are able to support you in designing and eva­lu­ating stud­ies, responding deficiency letters, as well as in the pre­pa­ra­tion for regulatory meetings.

Helmut Schütz is a chemical engineer by training and worked in the pharmaceutical industry as well as for twenty years in a Con­tract Research Orga­ni­za­tion, where he established a La­bo­ra­tory In­for­ma­tion Manage­ment Sys­tem cer­ti­fied accord­ing to the rules of GALP, helding senior man­age­ment posi­tions, most recently as head of the bio­sta­tis­ti­cal de­part­ment.

Since 2004 Mr Schütz is an inde­pendent consultant in the do­main of com­pa­ra­tive bio­avail­abi­lity studies; since 2022 he is a lec­turer at the Insti­tute of Medical Statistics of the Me­di­cal Uni­versity of Vienna.

He has extensive experience with GCP/GLP, bioanalytics, phar­ma­co­ki­ne­tics, and bio­statistics. His professional career spans 43 years and more than six hundred bio­avail­abi­lity studies.

Helmut Schütz is a member of the International Phar­ma­ceu­ti­cal Federation (FIP), the European Fe­de­ra­tion for Phar­ma­ceu­tical Sciences (EUFEPS), the American As­so­ciation of Phar­ma­ceu­ti­cal Scien­tists (AAPS), the Inter­natio­nal Bio­me­tric So­cie­ty (IBS), the Inter­natio­nal Society for Cli­ni­cal Bio­sta­tis­tics (ISCB), the Asso­ci­ation for Applied Hu­man Phar­ma­co­logy (AGAH), the Austrian Phar­ma­ceu­tical As­so­ciation (ÖPhG), the Euro­pean Net­work for Busi­ness and In­dus­tri­al Sta­tistics (EN­BIS), and the Austrian As­so­ciation of Con­sult­ing Engineers.

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