Achieving Excellence in Renal Research Despite Disruptions

To say the year 2020 was “unprecedented” is simultaneously accurate and an understatement. The pandemic entirely disrupted modern life while also bringing about much-needed change in the clinical research industry — change that was, in many cases, overdue. Fresenius Medical Care’s Global Medical Office developed a Global Pandemic Master Plan to provide structure and consistency in a world disrupted by a global crisis. As a Fresenius Medical Care company, Frenova benefited from this master plan.

While no one knows what the future holds, this plan is a solid foundation to prepare for any uncertainty, and our approach, focusing on four main areas of activation — people, product, process and policy, is a solid model that can help both sites and sponsors create their own actionable plan moving forward. 

People

The health and safety of patients and staff is always the top priority, so the master plan called for a fast and aggressive approach to personal protective equipment (PPE) to both mitigate the risk of exposure and help curb the virus’ spread.

Further, it created an efficient, effective restructuring of care logistics — changing dialysis shifts, providing PPE at a large scale, evaluating and modifying the layout of sites — while facilitating arrangements to allow patients to travel to and from treatment sites, adapting on the fly for patients involved in clinical trials with Frenova. Shift scheduling and time management further addressed any staffing challenges. Keeping patients, staff and associates as the main focus of your plan will allow you to create a people-centric approach that protects and supports your most important priority.

Product

The pandemic highlighted and exacerbated existing weaknesses across the clinical product supply chain as distributors struggled to get essential equipment and therapeutics to the front lines. As a result, many of those actively participating in trials faced disruptions.

The pandemic showed that the study drug supply chain can be affected. Even with meticulous planning, strategies — home health services for clinical study drug administration for example — study drug supply could still be an issue. Creating contingency plans to prepare for future material shortages, while also working with supply chain providers to secure critical products, are wise steps toward being prepared for any future disruption.

Process

As the pandemic’s impact across the globe spread rapidly, streamlining logistics and creating efficiencies to handle challenges that unfolded were keys to short- and long-term success. Adapting to use remote monitoring and home health care services was one approach, as well as video conferencing solutions to aid in recruitment and enrollment for clinical trials.

Staying agile and responsive while incorporating technology into your solutions will help keep your organization running smoothly during times of crisis. For Frenova, this provided the ability to draw on experiences across Fresenius Medical Care’s network of dialysis centers to provide insights for our clinical trial sites and patients.

Policy

At Frenova, we collaborated with our managed and partner sites to ensure patient safety at every level while closely monitoring guidance on COVID-19 infection control recommendations in the chronic, outpatient dialysis environment and beyond. Public health policy affected how sites and sponsors could operate. Being clear on your policies — both within your company and externally while actively communicating with your partners — helps ensure and maintain the safety of all patients at all times.

Plan for the Future Now

Planning now to address evolving challenges your site might face will benefit every stakeholder. Having a solid plan not only prevents disruption during a crisis, but it helps create stability during times of calm, as well. Knowing your organization has proactively created a crisis plan will help your patients and staff worldwide to feel safe and confident, regardless of what the future holds.

Want to ensure your organization is as well-prepared as possible? Please reach out and connect with us.

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