Services > Study Management

ACC GmbH Analytical Clinical Concepts is involved in the conduct of studies. This could be related to the complete study performance or only parts of the study (e.g. preparing of protocol, clinical part, analytical part, data evaluation, audits, preparing of study report) The studies refer to investigations on bioequivalence and bioavailability (e.g. influence of food, PK-interaction, dose proportionality, studies on dermal resorption) in healthy subjects and patients as well as special collectives (e.g. renal insufficient patients, hepatic insufficient patients, hypogonodale patients, renal transplanted patients and studies with elderly patients, postmenopausal women).

ACC GmbH has experience in the conduct of more than 400 studies and provides along with study management the following services.

Study planning
  • Development of suitable study programs and study designs
  • Selection of clinic unit
  • Investigation of pharmaceutical quality of the study medication
  • Collaboration on preparing the IMPD
  • Compiling and submitting the relevant study documents to authorities and ethic committees
  • Request of EudraCT number
Study organisation/-coordination
  • Time scheduling and monitoring of dates (protocols, approvals, approval of narcotic drugs (where applicable), shipment of study medication, clinical part, shipment of study samples, analytical part, biometrics, reports, documentation and archiving)
  • Preparing of status reports for the sponsor and exchange of information between involved parties
  • Shipment of study medication under temperature controlled conditions
  • Shipment of study samples under temperature controlled conditions
  • Audits (system audits, study audits)
  • Monitoring of studies in cooperation with partners
Study documentation
  • TMF and documentation according to GCP
  • Medical Writing
  • Archiving according to GCP