SERVICES

Monitoring:

  • Preparation of monitoring plans and forms

  • Evaluations for risk-based monitoring

  • Study initiation

  • Monitoring and SDV
  • Drug Accountability
  • Remote Monitoring

  • Document management at the study site

  • Co-monitoring

  • Study termination / close-out

Selection and organisation of study sites:

  • Feasibility process
  • Site selection
  • Prestudy evaluation visits
  • Guidance on compilation of the study team for your study protocol
  • Preparations of the study site prior to the conclusion of the contract in 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
  • Ethic committees submissions
  • Submission to health 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
  • Peparation of stdy documents
  • Preparation of Trial Master File and Investigator Site File
  • Document management and filing
  • Support of the monitor team

Data management:

In cooperation with our partners CDMS GmbH and HERMESOFT 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 enquiry.

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 international Guidelines and national laws)
  • Preparation of audits and inspections
  • Execution of audits (in-house and/or on-site)

Non-interventional studies:

  • Notifications to ethics committees and health authorities
  • Study support and monitoring
  • Data management
  • Analysis and reports