Spectrum of Services by SMO


For clinical trials of industry sponsors as well as those of publicly funded (grant holding), established study groups, the ZKS Leipzig - SMO offers active support to the primary investigator directly in the specific hospitals and private practices involved.

Services Offered:

  • Unburdening of hospital physicians from technical-administrative tasks through trained study assistants:Documentation (transfer the data into the CRF, inventory of medicine, study-associated forms and lists etc..)
  • Production and monitoring of patient visit schedules, visit scheduling for walk in patients
  • Visit preparation (e.g. pre-entry into a CRF, vial labelling and collection of spent medicines, filling out laboratory -, X-ray -, and CT forms)
  • Support with patient visitation (e.g. blood pressure, weight, blood draws, - preparation and - dispatch, mailing of samples or graphics to reference centres, dispersal and collection of patient questionnaires etc..)
  • Administration of test medicines or test products (e.g. reorder of tablets, confirmation of acceptance, patient expenditures, counting of returned patient tablets, monitoring of the expiration dates, return of medication to sponsors)
  • Management of primary investigator files (current actualization of essential documents, filing of correspondence)
  • Supporting the monitor with comparisons of the original data, correction of incorrect CRF entries
  • Continuous support of patients and documents in interdisciplinary trials (e.g. during cancer trials), after transfer as well as in partly ward based, partly ambulatory running clinical trials


Last updated: 15-Jun-2015