ICH GCP E6 (R2) – Are pharma companies ready to ensure Clinical Trial Oversight?

Mar 5, 2018 | Uncategorized

It’s been more than a year since the ICH GCP E6(R2) addendum became effective. The reasons which brought the Authorities to update the ICH GCP regulation are clear: on one side the increasing complexity, scale and overall costs of the clinical trials, on the other the strong shift from a paper-based clinical trial process to an electronic data capture and management one. Among the phases mentioned in the addendum (clinical trials design, conduct, oversight, recording and reporting) the oversight is gaining each day more relevance:

  • Are projects performing as planned?
  • Are partners respecting quality agreement?
  • Are the documents produced by partners enough and effective?

Pharmaceutical and Biotech companies are required to implement a more structured and comprehensive monitoring of their projects. In particular, the addendum focuses on the relationship between sponsors and CROs, as stated in the addendum to article 5.2.2.:

The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s)”.

What is Clinical Trial Oversight?

A set of processes put in place by the Sponsor and the CRO aimed at providing the former with an updated, constant overview on CRO’s performances, deliverables and results.

What is Clinical Trial Oversight Objective?

Enhance a more transparent and efficient communication about projects’ status, timelines and results between Sponsors and CROs ensuring global alignment   

But, if for Sponsor CROs’ oversight is considered to be a #1 priority, it is also true that most of companies find it extremely difficult to design and implement a shared and efficient set of processes to reach this goal. As the GCP states, digital transformation in Life Sciences industry led to enormous changes, representing at the same time a great opportunity and a challenging reorganization. Thanks to IT innovations, information, data and documents can be now collected, organized and shared in a more efficient and cost-effective way. The other side of the coin is that these disruptive modifications are not often included in a comprehensive digital strategy, leading to a lack of integration of the different applications utilized by the company’s departments. What does this mean?

  • Resources devoted to the download and the up-load of data from one application to another;
  • Compliance issues related to the System Validation of the different platforms (CSV);
  • Great increase of the risk of human mistakes due to data manipulation;
  • Risk of out-dated reports for the management team;
  • Delays in activities with a significant impact on the study budget.

As it has been widely discussed in the last months, the ICH GCP E6 (R2) put the need of a Risk-Based Quality Management System under the spotlight. In fact the Addendum 5.0 states:

The sponsor should implement a system to manage quality throughout all stages of the trial process. […] The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected.”

Companies are therefore required to implement a risk-based QMS to support each phase of the whole trial. The adoption of a Clinical Trial Oversight allows real-time monitoring of specific compliance and processes KPIs, identified during the risk analysis phase. This embraces the philosophy introduced by the ICH E6 addendum encouraging the use of improved and more efficient approaches/ tools to clinical trial oversight in order to avoid unnecessary complexity, procedures, and data collection.

It is clear: clinical trial oversight represents a mandatory requirement both from a regulatory perspective and from a strategic management point of view. The path towards the successful implementation of such a widespread improvement cannot be considered easy, but 3 main steps that every Sponsor should follow in order to ease the process have been identified:

  1. Requirements Analysis

    As a first step, it is fundamental to create a detailed map of the stakeholders (internal or external) involved in every activity, their responsibilities, tasks, data produced and of course, IT applications utilized. This analysis will help in the identification of the specific Sponsor’s requirements;

  2. Oversight Model EvaluationHaving a clear overview of the requirements, it is now time to evaluate the multiple ways an Oversight process and consequently system can be designed and implemented. Is it better to introduce a horizontal global application? Would a central integrated projects management and control cockpit be the best choice? In this phase these questions will find and answer;
  3. Oversight System ImplementationRequirements have been identified, alternatives evaluated and the best solution was found. Sponsor and CROs approach now the final phase: the pragmatic creation of a more connected and integrated environment where it is possible for the Sponsor to examine data, monitor activities and have a real-time overview of CRO’s performances.

As stated in the previous paragraphs, these 3 macro phases involve several actors performing multiple processes, for this reason, the role played by Quality Assurance Department is crucial. Ensuring a streamline risk-based QA Management system (Standard Operating Procedures, Quality Manuals, Policies…) throughout all stages of the trial process allows Sponsors to meet regulatory requirements avoiding compliance pitfalls.

Is your company compliant with Clinical Trial Oversight GCP?

We at Arithmos have developed a comprehensive approach for Clinical Trial Oversight Management: from requirements analysis to the vendor selection and implementation of the solution. In collaboration with its strategic partners, Arithmos also provides complete support in the re-organization of Quality Systems using the Risk-Based Approach. Would you like more info on this topic? Just send us an email!


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