PHAROS GmbH Clinical Trial Elements and Procedures
	Concept
	Intended purpose of the study Regulatory requirements in countries for registration Anticipated date of submission for registration Resource and budget analysis Assignment of one single Project Manager
	Design and Documents
	Alternative study designs to select most appropriate Possible combination of endpoints into one single study ICH-GCP conform protocol, informed consent, CRF Optimised procedures prevent possible errors Virtually no post study corrections, reducing cost and time
	Ethical Approval, Authorities, Insurance
	All managed by PHAROS GmbH, BfArM submission included Ethical approvals for international registration Time requirements minimised No sponsor intervention necessary Volunteer insurance provided by PHAROS GmbH
	Study Population
	Large volunteer database Special populations, e. g. non-smokers, elderlies, sterilised females Optimised and fast recruiting and screening procedures All laboratory parameters available, incl. HIV-Test Volunteers' elegibility verified in central German database
	Clinical Performance
	39 to 45 overnight beds plus 7 intensive monitoring beds All routes of drug administration possible, including i.v. Unlimited in-house periods for up to 45 volunteers at a time 24 hours a day medical care and supervision All procedures highly standardised, including any diet
	Analytics
	GLP certified laboratories Sample work up and storage controlled continuously All methods validated according to international standards Methods include: HPLC, LC-MS, MS/MS, GC-MS, RIA, EIA Analyses include pre-study and in-process validation
	Biometrics
	Optimised documentation, avoiding transcriptions All data checked 100% within 24 to 48 hours of generation Used software are SAS, BIOQ, TopFit, Proda and others if required Custom programmed applications are validated  Validated electronic data transfer into any format
	Reporting and Archiving
	Continuous Clinical Trial Progress Report  Integrated final study report according to ICH-GCP Independent GCP-Audit incl. Audit Certificate  Standardised study master file according to ICH-GCP All study files archived for 15 years
	All activities controlled by our ISO9001 Quality Management System All activities regularly reported in Clinical Trial Progress Reports back to our Services