Über uns

P.R.I.S.M.A. is a German Clinical Research Organization (CRO) and dedicated to support the European portion of the pharmaceutical and biotech industries’ clinical development programs. We offer the following customised services either on a stand alone basis or as part of an integrated “full-service” solution:

• Feasibilities for national and pan-European clinical trials

• Development of study design and study protocol

• Development of paperbased Case Report Forms (CRFs)

• Preparation of all study related documents

• Recruitment of study sites

• Contract negotiations with study sites

• Insurance handling

• Request for authorisation of clincial trials at competent authorities

• Submission of clinical trials to Ethics Commitees (ECs) for favourable opinion

• Training of the study personnel

• Planning and conducting of investigator meetings

• Clinical project management

• Clinical monitoring (phase I - IV)

• Payment of investigator and/or study personnel fees

• Study supply management

• Pharmacovigilance / Drug safety

• Medical monitor

These services can support both European and locally managed projects.

Specialties

Early Phase Clinical Development - The right go/no-go decision is a critical step in drug development. We are focused on Proof of Concept studies in orphan drug diseases particularly Pulmonary Arterial Hypertension (PAH).

Impressum: http://www.prisma-cro.com/contact.html