It has been more than a year since the ICH GCP E6(R2) addendum became effective and it is clear that the authorities updated the ICH good clinical practice (GCP) regulations because of:
- the increasing complexity, scale and overall costs of the clinical trials
- the strong shift from a paper-based clinical trial process to electronic data capture and management
Of the phases mentioned in the addendum (design, conduct, oversight, recording and reporting) it is oversight which is daily gaining relevance. Considerations must include:
- are projects performing as planned?
- are partners complying with quality agreements?
- are the documents produced by partners adequate 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 Contract Research Organisations (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).”
Clinical trial oversight
This requires a set of processes, put in place by the sponsor and the CRO, with the aim of providing the sponsor with a constantly updated overview of the CRO’s performance in projects, timelines and results. The objective is to ensure global alignment by improving transparent and efficient communication between sponsors and CROs.
But although, for both sponsor and CRO, oversight is considered a priority, most companies find it extremely difficult to design and implement an efficient, shared set of processes to reach this goal. As the GCP states, digital transformation in the Life Sciences industry led to enormous changes, representing a great opportunity while, at the same time, demanding a challenging reorganisation.
Thanks to innovations in IT, information, data and documents can now be collected, organised and shared more efficiently and cost-effectively. However, these initially disruptive modifications are not often included in a comprehensive digital strategy, and this produces a lack of integration of the different applications employed by the various departments.
This leads to:
- Resources being wasted on moving data between non-integrated applications
- Compliance issues related to the Computerised System Validation (CSV) of the different platforms
- A considerable increase in the risk of human error due to data manipulation
- The risk of out-dated reports for the management team
- Delays in activities, with a significant impact on the study budget
As has been widely discussed in the last months, the ICH GCP E6 (R2) put the need for a risk-based Quality Management System (QMS) under the spotlight. In fact, 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 trial. The adoption of clinical trial oversight allows real-time monitoring of specific compliance and process KPIs identified during the risk analysis phase. This embraces the philosophy introduced by the ICH E6 addendum encouraging the use of improved approaches and tools for clinical trial oversight, in order to avoid unnecessary complexity, procedures and data collection.
It is clear that clinical trial oversight represents a mandatory requirement, from both regulatory and strategic management perspectives. The path towards the successful implementation of such a widespread improvement cannot be considered easy, but three main steps have been identified that every sponsor should follow in order to ease the process.
1. Requirements analysis
A first step is to create a detailed map of the stakeholders (internal or external) involved in every activity, their responsibilities, tasks, data produced and, of course, the IT applications to be employed. This analysis will help in the identification of the specific sponsor’s requirements
2. Oversight model evaluation
Having reached a clear overview of the requirements, it is now time to evaluate the multiple ways an oversight process and resulting system can be designed and implemented. Is it better to introduce a horizontal global application? Would a centrally integrated project management and control cockpit be the best choice?
3. Oversight system implementation
Requirements have been identified, alternatives evaluated, and the best solution found. Sponsor and CROs now approach 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 gain a real-time overview of the CRO’s performance.
These three macro phases involve several players performing multiple processes. This means that the role played by the Quality Assurance department is crucial. Ensuring a streamlined, risk-based QA management system (including Standard Operating Procedures, Quality Manuals and Policies) throughout all stages of the trial process allows sponsors to meet regulatory requirements and avoid compliance pitfalls.
Is your company compliant with Clinical Trial Oversight GCP?
At Arithmos, we 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 our strategic partners, we also provide complete support in the reorganisation of Quality Systems, using a risk-based approach. For more information on this topic just send us an email!