Services

As a study centre of the Eye Hospital Tübingen, we are a reliable partner for all matters concerning clinical trials. We are part of the EVICR.net network of excellence for studies in ophthalmology. Our EVICR.net certified SOP system guarantees high standards.

- - AMG, MDR and professional-regulation-studies according to ICH-GCP
  - IITs and industry-sponsored studies
  - EU projects
  - Projects of the Federal Ministry of Education and Research (BMBF)
  - Projects of the Deutschen Forschungsgemeinschaft (DFG)
  - Projects of the Foundation Fighting Blindness (FFB)

Clinical trials of all phases

Planning and consulting for preclinical trials

- - Development of new therapeutic approaches
  - Ophthalmological examinations and specific functional diagnostics in vivo
  - Protocol development

Regulatory Processes

- - Writing and compiling essential documents
  - Submissions to ethics committees and higher federal authorities
  - Constant exchange with the authorities

Device Development

- - Pupillographic Sleepiness Test (PST)
  - LUVIS and LUVISmini

Gene Therapy

- - Regulatory processes
  - Central operating center for multicenter, international gene therapy studies
  - 8 ongoing and/or completed gene therapy trials
  - Indications to date: Retinitis Pigmentosa, Achromatopsia, Choroideremia, Leber Congenital Amaurosis (LCA), Geographic Atrophy in AMD.

Investigator Initiated Trials (IITs)

- - Advice on planning and conducting IITs
  - Gene therapy IITs since 2015
  - Current funding of our IITs by DFG, BMBF and other foundations
  - Project management
  - Development of study documents

CRO Services

- - Protocol development
  - Consultation
  - Planning
  - Preparation
  - Submission
  - Implementation
  - Analysis/Final reports