Mitigate risks before they can happen with our Risk Management Services

We help you establish and maintain a proactive risk management strategy, so you can identify, track, and mitigate risks efficiently before they impact your clinical trial and patient safety.

Benefits of our risk mitigation process

With our risk management service, you’ll get:

We work with you to establish and maintain a proactive risk management strategy, enabling you to mitigate them before they happen.

We take care of the possible emerging risks, freeing up time so that you can focus on the current situation, issues, and resolutions that need your direct attention.

Ensure that your data is complete, accurate, trustworthy, and reliable to stay ICH GCP E6 (R2) compliant.

Proactively identify risks and initiate mitigation processes and procedures to secure your patient’s safety.

We support you in the setup of all relevant risk management processes and the ongoing monthly operations.

Get in touch

Our focus is on helping sponsors with their oversight responsibilities by facilitating the development and implementation of a risk management system to ensure quality clinical trial results.

We work with you to establish and maintain a proactive risk management strategy, letting you identify, track, and mitigate risks before they impact your clinical trial and patient safety.

What to expect with our process

We develop the processes and tools to establish and maintain a proactive risk management approach, from the set-up all the way through to the monthly operations.

Risk Identification & Tracking

Our international team of risk assessment consultants have seen it all. They can help you predict risks you haven’t considered yet, and track them as they evolve.

Reports and Plans

We get you ready for the worst, while also helping you ensure it never happens. And, we help you put together reporting that keeps your key stakeholders informed.

Partner Communication

We are communicating your risks to your CRO/vendor partners so that they can be easily understood and effectively accounted for.

Ongoing Support

We’ll continue to support your monthly operations, reviewing everything from KPIs to meeting minutes – as your risks shift and change, we make sure you keep anticipating and addressing them.

Seuss+ Risk Management Process

Step 1

Setup

Setting up risk management consists of developing the Risk processes, Risk agenda, Monthly report template, Risk log, and SOPs on risk management in order to be audit ready.

Step 2

Operations

As part of the monthly operations, we facilitate the organization of risk meetings, updating and monitoring the risk log, development of the periodic reports, and distributing information to the proper channels

This process involves identifying risks by reviewing sources, assessing risk likelihood, detectability, and impact, determining the risk mitigation approach, and following up on actions taken to mitigate risks.

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