Coordination

As part of our support for the conduct of clinical trials at research sites, we undertake the following tasks with our qualified colleagues, tailored to individual needs:

• Support for patient recruitment: pre-screening of patients based on protocol-specific criteria, active participation in patient recruitment campaigns initiated by the sponsor

• Comprehensive preparation and support for patient visits, including scheduling patient visits by phone

• Maintenance of site and patient-level study documentation (e.g., investigational product documentation, lab requests, imaging studies, questionnaires, appointment requests, etc.)

• Source document management: support in creating visit-specific templates according to the protocol, checking data, and collecting missing signatures

• Completion of electronic or paper-based Case Report Forms (CRF)

• Responding to queries, supporting data clarification processes, and administrative support for safety reports

• Communication with investigator team members (e.g., correcting data according to GCP, collecting training logs)

• Handling of study samples and related tools and supplies (sending, ordering, and tracking)

• Participation in the patient reimbursement process

• Participation in telephone and in-person monitoring visits and resolving administrative requests arising during visits