Sponsor Archiving Service
The recognition that archiving is vitally important has added to and increased the demands on archiving in every aspect of pharmaceutical development. With the sponsor company (or CRO) in mind, Phlexglobal offer a dedicated, confidential and efficient solution to your archiving management. Whether providing a single archivist or a full team of archiving professionals, Phlexglobal has appropriately experienced and trained personnel.

In all projects a "Nominated Archivist” will be assigned to take responsibility for operational planning and liaison between the sponsor company and Phlexglobal archiving storage associates. We can manage your archiving “in-house” using your existing systems or processes or we can take complete responsibility by removing the archive off-site to one of our professional alliance partners. The high price of office space makes the option to store documentation off-site particularly attractive to sponsor companies.

Phlexglobal can provide the sponsor company with a suitably qualified "Nominated Archivist" for a variety of services, for example,

• Provision of quality & qualified archivists (short or long term)
• Storage of clinical research documentation
• Full logistical support (e.g. supply of boxes, couriers, cataloguing)
• Complete & timely retrieval and "Return-to-Archive Service"
• Secure and confidential destruction.

Investigator Archiving Service
The EU Directive has placed the responsibility, clearly 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 does recognise the difficulties this can cause the investigator and does allow 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. We provide 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 the Investigator Site with a suitably qualified ‘Nominated Archivist’ for a variety of services, for example,

SOP writing and/or review, on-site assistance, provision of quality & qualified archivists (short or long term), storage of clinical research documentation (BS5454 compliant, full logistical support (e.g. supply of boxes, couriers, cataloguing), complete & immediate retrieval and "Return-to-Archive Service", secure and confidential destruction.

Contact Karen Roy at Phlexglobal today (01494 720420, kroy@phlexglobal.com) for more information.