GXP Engaged Experience

Sponsor Location	Scope of Work	Tasks	No. of Audits	Target Countries
Germany	Qualification of Suppliers, On-site audits	Supplier audits, On-site audits, QA trial oversight	14	Russia, Ukraine, Poland, France, UK, Germany, Romania, Netherlands
Austria	Qualification of Suppliers	Supplier audits	2	Germany, US
Austria	Qualification of Suppliers	Supplier audit	2	Germany, Austria
Israel	Qualification of Suppliers	Supplier audit	2	Germany
Germany	Qualification of Suppliers	Supplier audit	1	Germany
Austria	Qualification of supplier	Audit of medical device company	1	UK
Germany	QA surveillance	Audit of sites, Support trial QA	15	Russia, Germany
Austria	QA surveillance	Supplier audits, Audit of sites, Support trial QA	25	Russia, Romania, Austria, Germany, India, Baltic States
Germany	QA surveillance	Audit of sites, TMF audits, support trial QA	8	Germany
Germany	QA surveillance	Audit of sites, QA trial oversight	2	Germany, Slovakia
US	QA surveillance	Audit of sites, QA trial oversight	15	India, Germany
Austria	QA surveillance	Supplier audits	2	Austria, Germany
Germany	Documentation audits	Audit of Clinical Study Reports	10	Germany
US	Inspection preparation (FDA)	Training and audit of laboratories and sites, root cause analysis of results, inspection participation	10	India, Singapore
Germany	Inspection preparation (FDA)	Training and audit of sites, inspection participation, inspection participation	3	Germany
Austria	Inspection preparation (EMA)	Audit of site	1	Austria
Austria	Inspection preparation (FDA)	Audit of site	1	Russia

Company	No. of SOPS	No. of Forms	Scope of Work	Tasks
Switzerland	10	-	Clinical Research + Pharmacovigilance	SOP writing
Germany	45	75	Clinical Research	Review of existing, Writing of additional SOPs
Switzerland	36	46	Clinical Research + Pharmacovigilance	SOP writing
Switzerland	31	44	Clinical Research	Establishment of new QM system incl SOPs
Austria	30	52	Clinical Research	Establishment of new QM system incl SOPs
Germany	26	44	Clinical Research + Administration	SOP writing and updating
Austria	25	-	Clinical Research + Pharmacovigilance	Establishment of new QM system incl SOPs
Germany	10	25	Clinical Research	SOP writing
Germany	32	-	Clinical Research	Establishment of new QM system incl SOPs
France	76	Ca. 180	Clinical Research	Establishment of new QM system incl SOPs
Belgium	22	47	Clinical Research, Pharmacovigilance, Regulatory Affairs, Human Resources, Finance, Sales and Marketing	Establishment of a new QM system incl Quality Manual and SOPs