Peachtree BioResearch Solutions

Update on the Impact of COVID-19

The impact of the COVID-19 pandemic on everyday business operations and peoples’ lives continues to evolve. Different levels of quarantine and social distancing across the country are requiring flexibility and innovation to maintain some semblance of normal. The impact on the healthcare system is staggering, and further complicates the clinical trial research space that already operates in a rigid environment of subject safety, federal regulations, and data integrity.

Upon the earliest signs that the spread of the coronavirus could impact normal business operations, Peachtree took steps to minimize the disruption in business conduct to maintain the level of service our clients need and reduce the safety risk to our personnel. While normal operations at Peachtree include many work from home employees, and our systems have always been structured for remote access with full IT support, monitoring, and security, this pandemic has forced all companies to take additional measures until it subsides.

As an organization:

  • Implemented our Business Continuity Plan to incorporate work from home for headquarter based employees until at least mid-April

  • Notified all existing/prospective clients that Peachtree is open for business and has developed numerous strategies to maintain the continuity of clinical programs

  • Implemented weekly COVID-19 Department Operational Leadership Meetings to address impacts on resourcing, project deliverables, and concerns

  • Created initial strategic operational plans, SOP deviations, and revised monitoring plans for management of REMOTE Pre-study, Site Initiation, Interim Monitoring, and Site Closeout Visits

  • Developed technology strategy to either remotely access site EMRs (where allowed), load redacted source data into EDC systems

  • Developed potential processes to ensure the continued distribution and accountability of investigational product

  • Continuously monitor regulatory updates and new guidance. Some references that may be helpful:

    • FDA Guidance

    • MHRA

    • EMEA Guidelines

In addition, Peachtree has initiated a series of roundtable discussions involving our clinical research experts and interested industry representative to discuss current issues, concerns, and to brainstorm remedies to get through this period. From initial discussions, the primary concerns seem to relate to:

  • Impact of site closures/quarantine, staff reductions

  • Conduct of virtual visits or home visits – requirement for protocol/ICF amendments

  • Proper documentation of protocol deviations related to COVID-19

  • Impact on subjects in screening/qualification

  • Investigational product – accessibility and management

  • Potential IRB delays – new studies and notification of modifications to study conduct

  • Remote monitoring – access to source documents

  • Continuation of recruitment/enrollment

During this time, continued subject safety is the primary concern. The overall impact on trial integrity is unknown at this point. Taking steps now to minimize disruption with clear communication and robust documentation will not only keep a trial viable, but provide a framework for preparing for potential future major disruptions.

Peachtree is a resource – whether we are actively managing your program, or you desire to discuss issues affecting your program. Reach out to us at covid-19@peachtreebrs.com

And feel free to download some of our document resources:

Corona and regulatory requirements
23Mar2020
FDA Clinical Trial Conduct during
COVID-19 3-17-20

© 2019 Peachtree BioResearch Solutions, Inc.

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