cardiabase - one steap ahead in cardiac safety
www.cardiabase.com
cardiabase - one steap ahead in cardiac safety
CENTRAL MANAGEMENT
OF CLINICAL DOSSIERS
Relying on its logistical know how, and as a complement to its core activities, cardiabase embarked on the centralization of clinical dossiers by allocating the resources necessary to manage the communication and circulation of documents between clinical sites, central reviewers and study teams.
The critical nature of the information collected and redistributed implies strictly controlled conditions
- Confidentiality
- Blinding control
- Specific filing, separate from the Study Files
- Re-distribution of information to designated parties
- Close adherence to reporting time lines
Key Advantages
cardiabase has appointed a dedicated team to manage these projects.

All team members are well versed in logistics and have developed a unique know-how.
Tasks and responsibilities include
- Design and distribution of specific documentation and forms

- Tracking and collection of source documents from sites

- Filing and preparation for review

- Submission of documents to Central Reviewers

- Interaction and correspondence with Central Reviewers including face-to-face meetings

- Collection and processing of interpretations from Central Reviewers

- Providing study-specific reports and tools
© CardiaBase : one step ahead in cardiac safety