December 2, 2022
Risk assessment

Are you really ready to run a clinical trial? How can you best assess your clinical trial readiness?

We work with C-level executives and management boards and understand their objectives, constraints and timelines.  Do this before buying services for clinical data management, EDC, ePRO and biostatistics.

Using a fixed price, fixed delivery model, our clinical trial readiness assessment engagements are completed within 2 weeks  depending on the complexity of your therapeutic,  project timelines, and clinical research protocols. You can take the assessment and go to any clinical data management vendor.

We team with client management to focus on reducing clinical trial risk with practical methods and technology in the best possible schedule. Our capability to properly evaluate risk comes from our 6 step systems approach  and rich experience in delivering entire systems for clinical trials: front-end GUI, back end data processing, data modeling, systems integration, server engineering, information security, API integration, device management, data integration and remote, automated clinical trial monitoring.

Step 1 Set scope –  At the first meeting with the project sponsor, we set scope of business unit, operational functions, product(s), schedule,  participants and desired result – for example EMA approval for a digital therapeutic.

Step 2 Identify business assets – We decompose the clinical trial process into operational data and business processes and functions at risk.

Step 3 Identify software components – We map clinical trial application functions to  assets and decompose to clinical trial risk.

Step 4 Classify vulnerabilities– We estimate probability of occurrence and assess severity of threats to your clinical trial; for example:  Does your drug have interactions with other treatment and is there potential for serious adverse events?  What is the ability of sites to execute your protocol and how long will it take to discover issues?

Step 5 Build the threat model – We build a  risk model of your clinical trial using PTA (Practical Threat Analysis). We valuate assets, identify threats that exploit vulnerabilities and estimate levels of damage to assets.

Step 6 Build the risk mitigation plan – We calculate Value at Risk using the quantitative threat model, specify security countermeasures and build  a cost-effective, prioritized risk mitigation plan.    We work with you to  get management buy-in for the plan.

To learn more and get a free 30′ consultation contact us today.

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