Clinical Trials

As an independent institute, Conreso offers phase II-IV clinical trials across all sectors.

The focus here is on pediatric and oncological studies, and on the testing of vaccines.

The developmental path that turns an active ingredient into a pharmaceutical product is an expensive one. The efficacy and safety of medications and vaccines must be proven in clinical trials.

Our service secures crucial steps along this path, right up to their final approval.

                                   Clinical Trials - An overview of our Services                                      

Conreso provides comprehensive clinical trial services according to the requirements of the sponsor:

  • Study planning/consultation during study planning
  • Development of a clinical trial protocol/consultation during the development of a clinical trial protocol
  • Feasibility investigations and assessments
  • Statistic consulting
  • Verify and clear regulatory requirements
  • Obtain approval from the competent Federal Supreme Authority
  • Apply for a favorable opinion by the leading Ethics Committee
  • Transact the required processes with the involved local Ethics Committees
  • Fulfill the registration and information requirements of the regional supervisory authorities
  • Identify and recruit suitable trial centers
  • Create and procure study material
  • Study management and study logistics
  • Carry out investigator meetings
  • Train the site staff
  • Pre-study visits or visits to evaluate the trial centers
  • Initiation, monitoring and close-out visits
  • Monitoring with the great accuracy that sponsors highly value about Conreso
  • Conduct the study according to in-house SOPs or those of the sponsor
  • Log the study documents (Trial Master File)
  • Archive according to the requirements of the sponsor or Conreso SOPs
  • Subject/Patient insurance
  • Legal representative of the sponsor
  • Support for the safety follow-ups conducted by the Conreso Call Center
  • Collect and evaluate AEs
  • Collect, document and evaluate SAEs
  • Fulfill the reporting/information transfer requirements of the sponsor*
  • Annual Safety Reports (ASR) and SAE/SUSAR reporting*
  • Electronic reporting according to ICH-E2B*
  • Data Safety Monitoring Boards (DSMB)*

      *We provide these services in cooperation with the Hannover Clinical Trial Center (HCTC), our joint venture with the Hanover Medical School (MHH).


                    Medical Writing                     
  • Clinical Study Reports in ICH E3 format
  • Scientific and marketing-effective presentations

          Data Management and Statistics         
  • Concept and planning of databases
  • Planning process
  • Implement audit trails
  • Create CRFs (Case Report Forms)
  • Query check and query tracking
  • Plausibility check
  • Dual data entry for conventional CRFs
  • Data validation and data consistency check
  • Biometric statistics
  • Statistical evaluation and reporting
  • Consult on statistic questions