SERVICES

Monitoring

  • Initiation of Studies
  • Monitoring and SDV
  • Drug Accountability
  • Termination of Studies

Selection and organisation of study sites

  • Feasibility process
  • Site selection
  • Prestudy evaluation visits
  • Preparations of the study site prior to the conclusion of the contractn order to achieve a prompt start of the study
  • Support regarding the internal site organization
    (SOP‘s for sites, definition of responsibilities at the site, support regarding the contract design)

Project management

  • Coordination of the project and the personnel
  • Communication with international study teams
  • Preparation and transfer of necessary papers to Ethics Committees
  • Preparation and transfer of necessary papers to supervising authorities
  • Preparation and conclusion of contracts
  • Selection of external services (central labs, central ECG etc. ...)
  • Organization of Investigator Meetings
  • Implementation of measures to expedite patient recruitment

Data management

In cooperation with our partner CDMS GmbH we are able to offer data management services
based on validated and user-friendly systems (electronic or paper based CRF)

  • Data Management Plan
  • Statistical Analysis Plan
  • Creation of CRF
  • Database Setup
  • Data Entry
  • Query process
  • Data Transfer
  • Statistical Analysis
  • Tables & Listings
  • Study Report

Trainings

Training of personnel in the field of:

  • GCP
  • Monitoring
  • Patient recruitment,
  • Project management
    • study preparation
    • study execution
    • study termination

We also offer project specific training for clinical studies.

  • Training on other topics in clinical research on inquiry
  • Training for Study Sites (study coordinators, study nurses, investigators) in the field of:
    • GCP
    • patient recruitment
    • organization of sites

Quality management

  • Implementation of quality management systems and SOP‘s
    (based on ICH GCP Guidelines, EU guidelines and national Drug Laws)
  • Preparation of audits and inspections
  • Execution of audits (in-house and/or on-site)

Non-interventional studies

  • Notifications of the Ethics Committees and state authorities
  • Study support and monitoring
  • Data management
  • Analysis and reports