Benefits of ICH-GCP Guidance: Quality Risk Management

Benefits of ICH-GCP Guidance: Quality Risk Management

The ICH E6 Guideline, R2 from the Good Clinical Practices adopted at the end of 2016 causes mixed feelings in CROs. What they are mostly worried about is that this guideline will impact negatively resources, patients, and the processes of research, as well as will increase the burden of CROs and sponsors in terms of extra documentation and other requirements to be met.

The following facts suggest that their worries are not justified.

QRM as the Biggest Change to be Introduced by the Guidance Adoption

The biggest change brought by the adoption of ICH E6 Guideline, R2 is that CROs and sponsors will have to incorporate QRM – Quality Risk Management – principles into their clinical trials’ design and execution.

QRM has been practiced for over a decade in manufacturing to outline the key processes of risk assessment, control, review, and communication. The risk assessment stage of this management approach allows to identify, analyze, and evaluate risks. The stage of risk control allows to find out possibilities to reduce risk in certain areas while accepting a certain amount of it in the others. The results and outputs of every stage of the QRM application are to be reviewed and communicated to stakeholders of the process.

Benefits of QRM

Improved Efficiency

If performed correctly, QRM can save critical resources and time by streamlining all the processes beginning from trial design and implementation, and ending by data and oversight handling and regulatory reporting. And the ICH Guidance provides step-by-step, comprehensive guidelines as to how to set up and execute QRM processes, along with a set of useful tools for risk assessment and documenting.

Patient Safety

QRM provides a logical, streamlined step-wise process in terms of ensuring patients’ safety – an issue of paramount importance for clinical researchers. Even though CROs do a lot of every-day work in this area, QRM allows for a better and more structured approach and organization in this area.

Proactive Approach to Risk Management

Basically, QRM brings up to light crucial risk discussion and evaluation, forcing the industry to change its reactive approach to a proactive one in terms of risk management. Early risk identification makes issues easier to address and resolve.

Efficient Resource Distribution

Quality risk management principles allow for more effective and efficient use of staff by assessing risk across the entire development lifecycle and focusing resources first on areas with the highest risk. The benefit of this approach is that it results in improved timeline and budget of projects, in making better-informed decisions, and considerable cost savings.

Along with the mentioned benefits, there is another advantage that application of QRM principles gives to CROs and sponsors: it signals to regulatory authorities that risks in that company are minimized. This is something regulators appreciate very much and become willing to reduce the number and duration of their inspections. And that is something any CRO and sponsor are sure to appreciate.

To Sum Up

The results and tangible benefits of QRM processes’ introduction into a clinical organization can be seen quite quickly, especially if the company builds an effective roadmap to streamline the processes of identification, evaluation, control, communication, reviewing and reporting QRM across all its departments, functions and other involved stakeholders.