Phlexglobal offers a dedicated, confidential and efficient approach to archiving management, supporting current legislation regarding archiving and document management. This service includes assuring the sponsor that clinical trial data is securely stored in environmentally controlled conditions and can be retrieved in a timely manner. The investigator archiving service ensures the investigator site data is held independently of sponsor company control.

Sponsor Archiving Service

Phlexglobal provides an Archiving Consultant to take responsibility for the operational planning and liaison between the sponsor company and our archiving storage associates. We can manage your archiving "in-house" using your existing systems and processes or we can take complete responsibility for your archiving, following Phlexglobal's systems and processes before transferring the archiving off-site to one of our professional alliance partners or the client's archive facility.

Phlexglobal can provide the sponsor company with a suitably qualified and experienced archivist in accordance with the requirements of the European Directives, on a short term or long term basis for a variety of services including SOP writing and review, full logistical support, complete and timely retrieval and return to archive service and secure and confidential destruction.

Investigator Archiving Service

The EU Directive has placed the responsibility with the investigator for archiving their data to the same standards as those of a sponsor company. The investigator must provide the same levels of security, environmental controls and document tracking as the pharmaceutical companies. However, the Directive recognises the difficulties this can cause the investigator and allows for the sponsor to help the investigator financially.

Phlexglobal can give essential support to Investigator Sites in how to manage the volume of data and documentation that arises out of every clinical trial. The problem of storing bulky Case Report Forms and associated documents has been growing at an alarming rate over the past few years. The investigator must be able to produce this data, in a timely manner, when requested to do so by the regulatory authorities.

Many sponsors now offer their investigators assistance in the long-term storage of clinical documents; indeed, such an offer is increasingly recommended. Phlexglobal provides a ‘firewall' between sponsor and investigator to ensure the integrity of the data: providing a professional storage facility for the investigator site, while assuring the sponsor that the data is being securely stored and can be retrieved in a timely manner.

Phlexglobal can provide an archivist to participate in study close-out visits, provide training to clinical research staff and investigators in archiving procedures and write or review investigator archiving SOPs.