Clinical research

Clinical research

NeuroTransData GmbH conducts both phase II to IV clinical studies and non-interventional studies (NIS). Depending on the project and parties involved, NeuroTransData GmbH assumes the role of Site Management Organisation (SMO) or Clinical Research Organisation (CRO). NeuroTransData GmbH also develops its own ideas and concepts, testing them independently via its own study design in investigator-initiated trials (IIT).

Site Management Organisation (SMO)

As a Site Management Organisation (SMO), and in its role as a network of physicians, NeuroTransData GmbH is responsible for the coordination and guidance of the NTD centres involved. As the sponsor, the individual pharma company is ultimately responsible for the proper conduct of the study. In most cases, the individual pharma company will commission another Clinical Research Organisation (CRO) to conduct and manage the study. As an SMO, NeuroTransData GmbH takes on the task of Site Management of the CRO, with the following benefits for the sponsor and the CRO:

  • Access to a large number of experienced study centres in the physician network
  • Quick and easy centre identification via the NTD Intranet (CRO/sponsor ultimately selects the centres).
  • Central contract management via the NTD, where the negotiated conditions apply to all NTD centres.
  • Rapid and direct intervention with any problems, difficulties or deviations from the plan.
  • Continuous central flow of project status information via the NTD study platform, direct communication between CRO/sponsor and NTD.

Clinical Research Organisation (CRO)

As a Clinical Research Organisation (CRO) and in contrast to SMO activities, NeuroTransData GmbH is directly involved in the planning and implementation of clinical studies.The pharma company (sponsor) tasks NTD with carrying out the study in the role of CRO. Amongst other things, this includes producing the necessary documentation (study protocol, patient information and consent form etc.), submitting the study to the competent authorities and the Ethics Committee, centre identification (the sponsor is responsible for the selection), distribution of study documents, programming an electronic case report form for the study (eCRF), management during the study, pharmacovigilance, data management and the statistical evaluation and publication of results.

Pharma companies see the following benefits when they commission NTD as CRO:

  • Cost savings compared to engaging an international CRO.
  • Study planned and conducted with the participation of registered practising physicians, providing a practice-based study setting.
  • Direct contact with the clinical investigators, as they are NTD members.
  • Rapid handling of problems, difficulties and deviations from the plan by NTD.
  • Data entry via the NTD database (eCRF), for which NTD doctors and nurses receive special training.

Investigator-initiated trials (IIT)

NeuroTransData GmbH sets up and runs in-house ideas and concepts under its own responsibility as Investigator Initiated Trials (IIT). NTD is the study sponsor in this instance. Either internal resources or research funds acquired via public tenders or pharma companies with an interest are used for the study. NeuroTransData GmbH then publishes the project results in leading journals.