ZAS: Your central archiving partner for CRO services

The required retention period depends, among other things, on the type of study, regulatory requirements and sponsor specifications. ZAS supports CROs in the structured management of different retention periods.

Yes. Archive records from different studies and sponsors can be managed separately and traceably. Responsibilities, access rights, retention periods and archive records are structured according to the respective requirements. This enables the CRO to organize different sponsor requirements through a single central archiving partner.

Yes. ZAS can be integrated as a central archiving partner into the CRO service model. This enables the CRO to offer archiving as part of its own service to the sponsor while transferring operational execution to ZAS. In this way, archiving volumes can scale with new studies and customers without requiring the CRO’s own infrastructure to grow to the same extent.

ZAS has scalable archive capacities for different archive materials and data volumes. New studies, additional sponsors or larger archive volumes can be integrated into existing standardized processes. This allows the CRO to take on additional projects without having to build its own storage space, systems or additional archive structures for every increase. ZAS has more than 50 high-security archives and corresponding infrastructure for different archiving requirements.

Required archive materials can be specifically located and provided through a defined retrieval process. Digital data and scans can be provided at short notice; physical archive materials at ZAS in Germany are generally available within 24 hours. The processes and movements of archive materials are documented in a traceable manner.

Retention periods can be defined by study and customer and taken into account in archive management. This makes it possible to manage different retention requirements within a central archiving model. The CRO does not need to establish separate processes and archive structures for each sponsor.

Yes. ZAS can integrate the transfer and transportation of archive materials into the archiving processes. This also allows international projects and holdings from different locations to be organized centrally through a single archiving partner.

Yes. In addition to documents and electronic data, ZAS also takes over the archiving of suitable biological samples and retention samples under defined storage conditions. This allows different archive materials from a study to be organized through a single central partner.

ZAS performs data integrity checks upon receipt and throughout long-term archiving. Corresponding checks are also performed when migrating to other storage media. Integrity information can be provided for audits and inspections.

Existing data holdings from older systems or storage media can also be transferred as part of a controlled migration process. ZAS supports the process from data transfer and integrity checks through archiving to long-term retrieval and, where applicable, compliant destruction.

The CRO reduces its own effort for archive space, infrastructure, personnel and operational management. At the same time, it gains access to specialized GCP-compliant archiving processes and can organize different archive materials through a single central partner. Particularly with growing study volumes, this enables scalable archiving without the CRO’s own organization having to grow proportionally.

Key criteria include GCP compliance, experience with clinical studies, traceable processes, retrieval speed, data integrity, data security, flexible capacities, international logistics and a personal contact person. For CROs, it is also important that the archiving partner can map different archive materials and sponsor requirements in a scalable model.

Yes. In addition to physical archiving, ZAS also handles digitization and digital data management. This allows physical holdings to be digitized as needed and electronic archive records to be centrally managed and provided.

ICH GCP E6(R3) requires traceable management and retention of the records that are essential to a study. These include, among other things, clear identification, version control, controlled filing and the ability to specifically search for and provide records. If archiving or other study-related tasks are transferred to service providers, their management and long-term retention must also be regulated. ZAS supports CROs in implementing these requirements with standardized and GCP-compliant archiving processes.

ZAS handles the structured transfer, archiving, management and retrieval of study documents and electronic study data. Archive materials are recorded and managed in a traceable manner and kept available throughout the entire retention period. This allows CROs to integrate archiving processes as a fixed part of their own service model without having to build extensive in-house archive structures.

Large data volumes can also be transferred to ZAS in a structured manner and archived over the long term. Together, data types, formats, metadata, retention periods and access requirements are first defined. The transfer can then be carried out in a controlled manner; ZAS performs data integrity checks and ensures the long-term availability and retrieval of the archived data. ZAS already has experience with more than 50 TB of archived electronic data.

ZAS archives, among other things, electronic Trial Master Files (eTMF), raw data, database dumps, electronic laboratory data, and image and video data. Data from existing systems or older storage media can also be transferred as part of a controlled migration process.