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Our goal is to translate innovation into the most efficient clinical development plan.

We are strategic clinical development experts with a focus on indication selection, market evaluation, clinical regulatory expertise, development of study designs and study protocols, "Scientific Advice" up to "Full Service" in the execution of early phase studies for biotech, pharmaceutical and medical device companies.

www.gouya-insights.com
As an Austrian training company we offer you courses/seminars/trainings on the following topics:
  • AMG und EU CT Regulation
  • MPG und Medical Device Regulation
  • GCP/GMP/GLP
  • Statistics/Biometrics
  • Safety/Vigilanz
  • Clinical trials
  • PASS
  • NIS
  • PMCF
  • IIT
  • RWE
Our seminars are your key to success! Andreas Raffeiner and DDr Alexander Hönel www.gxp-konkret.com
Customised and individual contract research
  • STUDIES Planning/Monitoring/Analysis: Clinical drug and medical device studies
  • DATA acquisition and management: CRF/eCRF, DMP, DVP, database creation
  • MEDICAL WRITING: Study documents, abstracts, publications, posters, newsletters
  • BIOMETRY & CODING: Post hoc analyses & biometric data analyses, SAP, randomisation, data preparation, final report MEdDRA, ATC coding, conversion of legacy data
  • PHARMACOVIGILANZ: AE/SAE Management, SUSAR- Reporting
  • AUDIT-GCP/GDP
  • QUALITY MANAGEMENT: Consultant activities, SOP creation, QM support
  • PROJECT MANAGEMENT
www.cw-rm.com
 
  • ISO certified Austrian company
  • Supervision of clinical drug studies
Our services
  • Project management and monitoring of clinical trials and NIS (AMG & MPG)
  • Data acquisition, safety reporting and data management - user-friendly eCRF system: StudyMate
  • Patient recruitment services
  • SUSAR-Reporting
  • Corporate consulting and speaking engagements
  • Audits at test centres, at CROs or at the customer's premises
www.studien-monitor.at
 
  • Design of study protocols for clinical trials
  • Initial contact and centre selection for clinical trials
  • Support with patient recruitment
  • Global network and solutions for Phase I, IIb & III
  • Access to case studies and regulatory intelligence solutions
  • Optimisation of clinical development and commercial analysis
  • Mapping local demand in the hospital and pharmacy market
  • Forecasting and pipeline management
  • Quality, compliance and content management
  • Leading address database for HCP
www.iqvia.com
Celerion, a global leader of early clinical development services to the pharmaceutical industry, offers a unique combination of: medical expertise - clinical operations - scientific excellence First-in-Human to Proof-of-Concept as well as larger Phase II studies:
  • clinical study conduct, data management and biometrics, PK/PD analysis, bioanalytical services (onsite laboratories), medical writing,regulatory and drug development program management.
  • safety/tolerability, bioequivalence and bioavailability, drug-drug interaction, cardiovascular safety, ADME, renal & hepatic, respiratory, vaccines, infectious disease and oncology
  • Exploring drug effects in both healthy volunteer and patient studies
www.celerion.com

German Society for Pharmaceutical Medicine e.V.

The 'Deutsche Gesellschaft für Pharmazeutische Medizin e.V.' (DGPharMed) is a scientific-medical society that deals with the discovery, research, development, benefit/risk assessment, authorisation and marketing and continuous monitoring and safety of medicinal products, medical devices and biotechnological products, as well as with information and medical communication about them, for the benefit of patients and the public health system.

IFAPP, International Federation of Associations of Pharmaceutical Physicians & Pharmaceutical Medicine

The mission of the International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) is to promote Pharmaceutical Medicine by enhancing the knowledge, expertise and skills of pharmaceutical physicians and other professionals involved in all scientific disciplines with regards to the discovery, development, research and use of medicines world-wide, thus leading to the availability and appropriate use of medicines for the benefit of patients and the society.

SwAPP, Swiss Association of Pharmaceutical Professionals Inc.

SwAPP was founded in 1995 as the professional association for qualified specialists working in one of the many fields of pharmaceutical medicine and drug development. SwAPP members come from pharmaceutical companies, contract research organisations, health care institutions, biotech companies, health authorities and ethics committees.