Business Continuity Planning for Investigative Sites
Do you have a business continuity plan?
Since March 2020, there has been a worldwide pandemic, fires in California, power outages in Texas and, most recently, war in Ukraine. In the latter case, sponsors will need to adjust the ways clinical trials are run in that region and deal with the impact of protocol deviations and other consequences of the disruption. To address that need, EMA has issued advice to sponsors on managing the impact of war in Ukraine on clinical trials. It can be accessed here: Advice to sponsors on managing the impact of the war in Ukraine on clinical trials | European Medicines Agency (europa.eu)
Uncertainty about what might happen, whether it is a natural disaster, a pandemic, or a geopolitical event, does not mean you have to be unprepared. To address any kind of significant business disruption, you should have a business continuity plan in place.
In the life sciences industry, we encourage sites to be inspection ready. In the same vein, having a business continuity plan is good business practice. ICH E6 Section 4.12 requires that if a trial is prematurely ended or suspended for any reason, the investigator should assure appropriate therapy and follow up. Conducting a Business Impact Analysis and having a Business Continuity Plan provides assurance to Sponsors, CROs and your study participants that you are prepared to manage any significant disruptions to the business.
Conducting a Business Impact Analysis (BIA)
A BIA provides a systematic approach for analyzing the impact of a disruption on the critical functions of the business, what resources will be required to continue operations, and your recovery time objectives.
Consider what resources will be needed to put contingency arrangements in place. This might include:
- Ensuring staff have the ability (and equipment) to work from home
- Contracting with a staffing agency to supply staff if your own staff must quarantine
- Ensuring all essential staff have external batteries, power banks and cables if power is lost
When doing the impact assessment, it is helpful to think of the impact over time and consider key deliverables, e.g., supply of study medication and collection and reporting of safety and endpoint data. For example, 3 hours, 1 day, 3 days, 1 week, 1 month. In guidance issued by FDA, Sponsors are encouraged to consider flexibility in visit windows along with the use of electronic communications, including social media platforms, and mobile medical professionals such as nurses and phlebotomists, to reduce the burden of trial participation for patients. Similarly, MHRA in their Risk-Adapted Approach to Clinical Trials and Risk Assessments guidance, has encouraged sponsors and clinical service providers to build flexibility into protocols, SOPs, and risk assessments to lessen the impact of a disruption.
Once you have all that information compiled, plan to review it periodically and update it, as necessary. When and if a disruption occurs, that is the information you will use to populate your Business Continuity Plan.
A Business Continuity Plan (BCP)
The purpose of the Business Continuity Plan is threefold:
- To respond to the disruptive incident, i.e., incident management
- Maintain delivery of critical activities or services (business continuity)
- Return to business as usual (recovery and resumption)
All staff, as part of their on-boarding training, should be made aware that in the event of an incident, there is a plan in place to manage incidents and restore business operations as soon as possible. They should be encouraged to keep their personal contact details up to date and, if assigned a role as part of the business recovery process, be trained on their responsibilities.
It is good practice to have a business continuity team identified in the BCP. They should all be alerted once the plan is activated.
The purpose of the incident management phase is to protect the safety of patients and staff, protect vital assets, ensure necessary communication takes place, support business continuity (e.g., conduct study visits via telemedicine), and support the Recovery and Resumption phase.
Actions To Support Business Continuity
Actions to support business continuity include recovery of vital assets and equipment so business can continue, determining key priorities, letting staff know what is required of them, publicizing interim arrangements so clients and study participants know the contingency plans, and keeping an incident log to document decisions made and actions taken and, last but not least, keeping a record of expenditures made.
Depending on the incident, each study protocol and the schedule of procedures should be evaluated, as should the individual participants’ circumstances.
Actions To Support Recovery and Resumption
The purpose of the Recovery and Resumption Phase is to resume normal working practices for the team. Where the impact of the incident is prolonged, normal operations may need to be delivered under new circumstances, e.g., from a different building, remotely or even from a different country. You should conduct a debrief and ‘lessons learned ‘and get the word out that ‘business as usual has resumed’.
The WCG Avoca Quality Consortium (AQC) develops leading practice tools and templates based on subject matter expertise and collaboration including AQC Leadership Advisory Boards (LABs) comprised of AQC Member representatives who advise on and review AQC workstream developments. AQC Members can access a Business Impact Analysis Template and a Business Continuity Plan Template developed by the Site Quality LAB in response to the pandemic, which can be tailored for any type of disruption.
Learn more about becoming a Member of the AQC to access over 1,000 leading practices and metrics that you can use to help you prepare.
Brigid Flanagan, BA, RN, CCRC, MSB