Clinical trials rely on data and business continuity planning is a critical aspect to protect data during the required time. In the event of a disaster or even something as ordinary as a company going out of business in today’s economic climate, are your trial master files sufficiently safe?
If a site or contract research organization (CRO) closes down, who will keep information such as informed consents? And what about standard operating procedures (SOPs)? In the event that the CRO who conducted the study goes out of business, how can you ensure you will still be able to access all of the SOPs in such circumstances?
Escrow agreements are becoming increasingly relevant to ensure such relevant pieces of the clinical trial quality system and audit trail can still be retrieved in the event of an unanticipated event.
Business continuity can be defined as a proactive process which identifies the key functions of an organization and the likely threats to those functions and then, using this information, plans and procedures which ensure key functions can continue, whatever the circumstances can be developed.
If you need assistance to write your business continuity plan or to establish an escrow agreement for relevant clinical trial documents, contact us.
Did you know?
According to Symantec’s 2011 SMB Disaster Preparedness Survey, despite the fact that small and medium businesses are at risk, they are still not making disaster preparedness a priority until they experience a disaster or data loss. The data also reveals that disasters can have a significant financial impact on the companies.Contact us