On June 2017 ICH GCP E6 (R2) entered into force, introducing new guidelines and increasing the responsibility of the Sponsor when it comes to outsourcing the activities to the CROs.
“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).”
After ICH GCP E6 (R2) entered in force, sponsors needed to face the following obligations:
- Checking if the quality requirements, agreed with the CROs, have been met
- Confirming if the project execution, by the CRO, is aligned with expectations
- Implementing a risk-based QMS throughout the clinical trial
The reasons that 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 a digital-based one.
Challenges in ensuring oversight
Although now CRO oversight is considered to be a top priority for the sponsors, it is also true that designing and implementing the oversight process is extremely challenging. Introducing a technology solution is the most efficient way to ensure oversight due to the amount and complexity of data that needs to be analysed.
In order to perform oversight efficiently, this solution needs to:
- Give a global overview of all the company vendors involved in each study
- Convert non-homogeneous data into a format that is homogeneous and allows easy comparison, control, and performance analysis, for example, the visit frequency analysis
As very few sponsors are already in possession of such a solution, it needs to be acquired externally through a vendor selection process.
Technologies for ensuring oversight
There is a number of tools that the sponsors can adopt as part of their oversight strategy. The two most widespread are Clinical Trial Management System (CTMS) and Oversight solution.
CTMS is a type of software that merges the data from different sources and allows the sponsors to analyse it. CTMS is one of the most common tools on the clinical market and has planning and reporting functions that include participant contact information, deadlines, and milestones.
The main CTMS constraint is the low level of customisation of the tool due to limited integrated customization capabilities. With each CRO having its own report template, it is difficult to accommodate this variety with one CTMS, so only a limited number of studies and CROs can be overseen with it.
Additionally, a CTMS was born as a clinical tool, which limits the inclusion of other data like procurement and pharmacovigilance.
Clinical Oversight solution
A clinical oversight solution is another option that can be used by a sponsor in order to comply with the Addendum of ICH GCP E6 (R2).
An oversight solution is more than software, it is a complex package that includes the following elements:
- Business analysis activities to understand the need of the sponsor and review the types of data submitted by CROs
- Software that covers clinical, procurement, and pharmacovigilance aspects of the study
- Maintenance services and configuration of the reports of the new CROs
Oversight solution allows the creation of multiple dashboards thus being able to accommodate different formats of incoming data, which makes it a perfect tool for sponsors that have multiple CROs and multiple studies.
Being more complex than a CTMS, an oversight solution also comes at a higher price.
In this article, we will be focusing on the selection of a vendor for oversight solutions, as it is more flexible and allows the inclusion of a higher number of CROs and studies.
Oversight solution: vendor selection
Step 1: Kick-Off Meeting
During this step, the sponsor plans the project activity, defines roles and responsibilities, timeline, budget restriction, and outputs. It is critical to include the following participants who will be the key figures in the process:
- Project manager
- Business owner
- IT team representative (system owner)
- Key user that uses the data provided by the CROs; for example, a data manager
Step 2: Defining Business Requirements
The sponsor should list the main requirements for the oversight system. The best approach is starting with the higher-level expectations and defining only 5-7 main points. They help to understand the key micro-areas and to create a shortlist of the solutions available on the market.
Step 3: Vendor Selection and Assessment
At this step, the sponsor works with the shortlist of the oversight solution vendors compiled previously. Normally, the shortlist includes 3-5 solutions. The following actions will help to filter out the least suitable vendors and define the main candidates:
- Send to the vendor candidates a survey that gathers information of the size of the company, its capabilities, and its ISO certificates
- Set up a demo appointment and share the list of the oversight requirements during the demo. The advised time is 1-1.5 hours
- Request a ballpark estimate
- Create an evaluation matrix based on the survey and demo outcomes in order to understand which vendor has the highest score
When it comes to requesting the ballpark estimate, it is vital to keep the following in mind:
- All the potential vendors should receive the same description with the same requirements. The more precise and coherent the request, the more likely the different proposals will be comparable.
- The more flexible the solution, that the vendor offers, the less technical adjustments will be needed, allowing the sponsor to lower the expenses.
- Aside from the main ballpark estimate, it is important to keep in mind additional costs, like CRO onboarding and data dashboards personalization.
Step 4: Vendor Confirmation
Once the vendor is chosen, the sponsor conducts an audit and verifies the vendor’s compliance and the internal processes. This can either be done directly by the vendor or can be outsourced to an external consultant.
In case of a successful audit, the collaboration with the vendor is formalized with an appropriate contract.
Each of the four steps is very important for making the right choice and ensuring compliance. However, the most critical step is defining the requisites and the expected results. The correct definition at this stage is the secret for successful oversight and smooth collaboration.
Sponsors need to make sure that they involve all the stakeholders in the definition of the requisites and avoid the silos between the departments. If such key stakeholders as business department and IT teams are interested in different characteristics and have different expectations, sponsor needs to ensure that it shortlists the solutions that are a good trade-off for both of them.
Given the increasing outsourcing trend in clinical trials, it is not surprising that ICH E6(R2) was introduced, as it allows to address, in more detail, the relations between the sponsors and third parties. ICH E6(R2) has changed the way the information circulates between the sponsors and the CROs and has pushed the companies towards adopting new technology to collect, organize, and share the information in a more efficient and cost-effective way.
How can we support you?
Arithmos has extensive expertise in oversight vendor selection. We support you at every stage of the vendor selection, from business analysis to solution integration. Our extensive knowledge of oversight allows us to choose and customize for you an oversight solution that guarantees efficiency and compliance.