Business Continuity Plans (BCP) is not a novel concept, but COVID-19, with its global impact, unceremoniously put many companies’ BCPs to the test, steadily pushing the limits of BCP adaptability to our continuously changing landscape. With the uncertainty surrounding this pandemic, many companies are dusting off their BCPs to ensure they can weather this storm, no matter the duration.
In Clinical Trials, business and clinical trial continuity needs to focus on several key element, keeping subject safety, data integrity and GCP Compliance at the core of it all:
- Do you have a Business Continuity Plan?
- Do you have criteria and a process to determine critical needs and prioritize their business continuity roll out?
- Subject safety:
- Can you assure uninterrupted medical care of trial participants at investigator sites?
- Can you ensure uninterrupted subject trial treatment; both on and off site?
- Do you have plans for drug supply chain disruption mitigation/redundancies at Investigator sites and at patient’s home?
- How does the regional pandemic progress affect the trial activities in different regions?
- Data Integrity:
- Is it assured that - due to Force Majeure - any unplanned reaction on a situation (e. g. transfer of medication from Investigator sites to patients) will be appropriately scheduled, performed and documented?
- Do you have disaster-recovery in place to get supporting technology back up and running, or new technologies rolled out to adapt quickly to patient needs?
- Is your data and study materials backed-up?
- Do you have mitigations in place if it can’t be restored rapidly?
- In a pandemic event normal Clinical Trial execution might be not possible as health care professionals will deal with the pandemic; triage together with the sponsor the studies to determine a) new studies to be postponed b) set study on-hold, if patients safety permits c) identify studies that must continue
- Evaluation whether the oversight functions (monitoring, auditing) need to be remote or in person and in case remotely how long the remote oversight can continue?
- Which aspects of monitoring can be performed remotely, and which can only be performed on site?
- What systems do you have in place to facilitate remote monitoring; remote auditing and how to measure the quality of remote interactions?
- Communicate open the intended steps across CROs, Sponsors and Authorities, e. g. the activation of any BCPs
- Ability to work remotely:
- Establish horizontal and vertical communication lines to assure comprehensive flow of information
- Can your team’s work be done remotely (in the event the site is closed but staff are able to work from home)?
- What percentage and what type of your work requires on-site personnel?
- Prioritize work: what tasks require a timely work, or could be postponed without significant impact?
- What would be the minimum number of required personnel to keep the operation running?
- What are the specific activities that would require on-site personnel and what activities can be done remotely?
- Are the identified back-up personnel cross-trained to execute the required tasks?
- What are the essential systems and applications you need to continue your work?
- Subject safety:
- What contingencies are being developed if workers are limited or unavailable for on-site required functions, or if cannot complete their assigned duties?
- In the case that you have 3rd party contractors to support your operations, have they confirmed their business continuity plans with you?
- What is the end point of the BCP, to resume normal operations, is it the same across all functions, all regions?
And finally, when putting a BCP in motion – it kicks off with a bang but cannot be sustained at the same intensity indefinitely. Be aware and closely monitor and manage battle fatigue; communicate regularly and timely with all your stakeholders (internal and external).
How can Parexel help?
Parexel can conduct GCP investigator site audits remotely in this global restricted access period. We provide an independent evaluation of trial conduct and compliance as well as independent feedback of the continued standards of quality of clinical trials at sites that can no longer accommodate physical visits. The audit scope supports maintaining an oversight of the clinical trial whilst ensuring the rights, safety and wellbeing of the participants.
Additional information on how Parexel can assist with COVID-19 risk mitigation for your business operations, as well as, remote audit capabilities can be found here:
For more information please contact us.