P.R.I.S.M.A.

Clinical Research Organization

Who we are

P.R.I.S.M.A. is a privately held German Clinical Research Organization (CRO) and dedicated to support the European part of the pharmaceutical and biotech industries’ clinical development programs.



In 2007 P.R.I.S.M.A. has been established by three senior founders, bringing together a wealth of experience from major global clinical research organizations as well as from the pharmaceutical industry. We provide comprehensive services for designing, managing, monitoring and reporting on Phase 1 – 4 clinical research. Our reputation is based on competence, personal commitment and an effective client-oriented cooperation. We are proactive, focused and consultative partners, delivering expert knowledge to every project, ensuring convincing solutions for your clinical trial. We offer the following customized services either on a “stand alone” basis or as part of an integrated “full-service” solution:
Study
Start-up
  • Feasibility for national and pan-European clinical trials
  • Development of study design and study protocol
  • Preparation of all study related documents
  • Recruitment of study sites
  • Contract and budget negotiations with study sites
  • Insurance handling
  • Training of the study personnel
  • Planning and conducting of investigator meetings
Regulatory
Affairs
  • Request for authorization of clinical trials at Competent Authorities
  • Submission of clinical trials to Ethics Committees for favorable opinion
  • Submission of substantial and non-substantial amendments to the Competent Authorities and Ethics Committees
  • Ongoing communication with Competent Authorities and Ethics Committees
  • Submission of annual safety updates to the Competent Authorities and Ethics Committees
  • Submission of the clinical study report to the Competent Authorities and Ethics Committees
Study
Conduct
  • Clinical project management
  • Vendor management
  • Site management
  • Support of subject recruitment
  • Review of subject eligibility
  • Clinical monitoring (1 -4)
  • Payment of investigator and/or study personnel fees
  • Study supply management
  • Drug safety
  • Medical monitoring
Project
Rescue
  • Clinical trials are the most costly phase of development. Increasing costs, growing complexity, longer timelines due to false starts,delays, issues and obstacles during the startup phase and study conduct. P.R.I.S.M.A. offers project-specific rescue strategies regarding the implementation of the relevant corrective steps and trouble-shooting in order to get a project back on track.
Legal Representative
Services
  • Article 74 of the EU Clinical Trial Regulation (CTR) requires every sponsor conducting a clinical trial in the European Union not being established in the Union, to ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation.
  • We offer Legal Representative Services to ensure that international clients without a registered affiliate in any of the EU member states meet their legal requirements as the European representation is essential for the purpose of conducting clinical research projects in the EU.


These services can support both European and locally managed projects.


Why P.R.I.S.M.A.?


Lean and agile organization – full attention and dedication to each awarded project
         →Quick decisions, fast action
         →Minimal staff turnover since inception

Creative and driven to provide highly individualized client-oriented services

Strong and experienced team

Proactive communication

Committed to quality

Proven client satisfaction