Expediting an Urgent Sub-study for COVID-19 Treatment

During the global pandemic of 2020, Westat pivoted with urgency to help leverage existing infrastructure from an ongoing influenza study toward a sub-study for a COVID-19 treatment. Despite the challenges posed by the pandemic, our experts successfully implemented remote site monitoring and new safety procedures.

When a small commercial biopharmaceutical sponsor in the United States received positive signals from its influenza study drug, its researchers hypothesized the study drug could be a potential aggressive treatment option for COVID-19 patients. The evolving nature of the virus meant that a rapid start-up of a sub-study was imperative, and the sponsor called on Westat to support it. Leveraging the existing infrastructure, clinical sites, and vendors, our clinical trials experts went into high gear to efficiently achieve the sponsor’s goal: to rapidly onboard sites and recruit trial participants. 

Accelerating Site Participation

When it comes to choosing a CRO, you have a lot at stake: significant R&D investments, reputation, multiple stakeholder expectations – and always, the patients who stand to benefit from the treatments you’re developing. Our team pivots to address shifting priorities during the clinical research process. We pride ourselves on creative problem solving, especially for trials that pose unique challenges. We understand common challenges of trial implementation and develop solutions that efficiently bring treatments and therapeutics to market. Our team has experience designing and implementing clinical trials for oncology, infectious diseases, vaccines, rare and emerging diseases, and more.

Managing the Hurdles of COVID-era Trial Management

Trial management during COVID-19 was not without obstacles. Clinical site staff had to function remotely and their task loads were heavy; remote monitoring itself was difficult. Known for our creative problem-solving skills along with flexibility and innovation, our staff was up to the challenge. A hallmark of Westat’s unique experience, our proprietary standard operating procedures (SOPs) ensured study continuity fostered by seamless telework coverage and remote connections; use of virtual meeting systems; and immediate access to our staff – even stretching to weekends and holidays when critical needs arose.

Tackling the Challenges of Remote Site Monitoring

To navigate complex remote site monitoring issues, we seamlessly developed and implemented new procedures. These included surveying the sites to assess remote monitoring capabilities; flexibly adapting current remote monitoring SOPs to various site situations; and exploring new technologies to enhance remote monitoring resources (e.g., sites screen-shared with our clinical research associates and source documents uploaded to a secure Web-based system).

Delivering Trusted Outcomes During Times of Uncertainty

Despite the turbulence of COVID-19, the sponsor remained confident that our clinical trial experience, management prowess, and integrity would ensure compliance to the study protocol, attention to patient safety and confidentiality, and delivery of statistically sound and credible research data. We met that confidence with a commitment to transparency, collaboration, and the highest standards of excellence, accomplishing the sponsor’s project goals on time and on budget during a global pandemic.

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