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.

study site

CRO

gene therapy

Clinical trials of all phases

- - AMG, MDR and professional-regulation-studies according to ICH-GCP
  - IIT- 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)

Planning and consulting for preclinical studies

- - 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

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

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

Partners

- - Egon Schumacher Stiftung