Efficient project management is key to the success of your clinical trial. We offer:

– Project coordination: monitoring study progress and ensuring adherence to timelines and budgets.
– Quality management: Implementation of quality control measures to ensure data integrity and compliance with ICH-GCP standards.

We offer comprehensive monitoring and audit services to ensure study integrity:

– Study monitoring: regular review of study sites to ensure protocol compliance and data accuracy.
– Audits: Independent assessments to ensure regulatory compliance and identify areas for improvement.

The requirements for submitting studies to the authorities are complex. We are happy to support you with:

– Submissions to Ethics Committees
– Submissions to Competent Authorities
– Submissions to the Federal Office for Radiation Protection (Germany)

– Patient information and informed consent forms
– Protocol synopses
– CRFs (Case Report Forms)
– Submission documents
– Other documents

Are you lagging behind with data entry or do you need someone to update your investigator site file?

We gladly support you with

– Data entry into the database
– Planning patient visits, including preparation and follow-up