Particular risks in the selection and use of electronic data capture (EDC) systems in fully digital studies

MEDIACC uses different electronic data capture (EDC) systems and other programmes for fully digital clinical studies (DDCT-MED®) or hybrid studies.

Optimised EDC solutions for your clinical studies: quality, safety and efficiency

Our objective is to find the best possible combination of programmes for our customers and those involved in a clinical study (also clinical investigation, performance study) based on their performance specifications and our many years of experience. The parameters of quality/comfort, price and risks, which are often in a triangular relationship with each other, must be taken into account. These parameters must be compared with the requirements of a clinical study, defined by variables such as risk of the study, number of participants, study population, duration of the study or number of visits or complexity and length of questionnaires.

In doing so, we are also guided in particular by our experience with different providers and those from our strong network.

The EDC system forms the core of a clinical trial platform, which is usually supplemented by other technical programmes and services that are strongly driven by high standards.

The following risks are considered and managed when using different EDC systems for clinical studies:

Roles and responsibilities

It is clearly defined who is responsible for which aspects of the EDC systems - sponsor, investigator or external service provider. Responsibilities are contractually regulated and the division of tasks is set out transparently.

Data protection and data security

The confidentiality and integrity of the data collected must be guaranteed. Appropriate technical and organisational measures will be taken to prevent unauthorised access to the data. In addition, the applicable data protection regulations must be complied with.

Validation and qualification

The sponsor must ensure that the EDC systems are validated and qualified for the intended purpose. A risk assessment is required to evaluate potential risks to data integrity and establish appropriate controls. MEDIACC supports this with its experience and expertise.

User management and access control

Clear processes are established for user management and access control. Access is limited to the minimum required and changes are logged in a traceable manner.

Audit trail

EDC systems have a function for tracking changes (audit trail) so that all data changes are fully documented and their cause can be clarified.

In order to minimise these risks, MEDIACC undertakes important standardised process steps when selecting and using EDC systems:

• Carrying out a well-founded risk analysis and risk assessment.
• Clear contractual regulations with all parties involved
• Validation and qualification of systems in accordance with regulatory requirements
• Robust processes for data protection,
• user management and audit trails
• Continuous quality assurance of systems and processes

These measures are designed to guarantee the integrity and reliability of clinical trial data in the best possible way when using different EDC systems.

Process steps for optimal EDC solutions for your clinical studies: Expertise for maximum data quality and cost efficiency

As a CRO, MEDIACC supports its clients in selecting an optimal EDC system by carefully and comprehensively analysing various factors. Here are key process steps and considerations that MEDIACC takes into account during the selection process:

Terms of Reference and Adaptability

MEDIACC reviews the terms of reference of EDC systems to ensure that they meet the specific requirements of their clients' clinical studies. This includes the flexibility of modules, such as eCRF, eCOA, ePRO, and eSurveys, which can be combined as required. Systems with scalable architecture are suitable for consecutive studies.

Data security and data protection

In Europe, great importance is attached to data security and the protection of patient data. EDC systems must meet the highest standards and be compliant with EU and US data protection requirements. Confidence in such a system is the basis for the decision of various stakeholders to approve the study in the proposed architecture, such as ethics committees, data protection officers of hospitals or authorities, or of study participants to participate in the study at all.

User-friendliness and efficiency

Another important aspect that must be considered at an early stage is the user-friendliness of EDC systems. Systems that offer an intuitive user interface and simple operation. They increase acceptance and efficiency, increase the retention rate of study participants and the inclusion rate of investigators and shorten the time in the planning and preparation phase of a clinical study.

Validation and qualification

EDC systems must be validated and qualified to conduct GCP-compliant clinical studies of different risk classes. This includes a risk assessment to evaluate potential risks to data integrity and establish appropriate controls.

Costs and benefits

MEDIACC considers the cost-benefit ratio of EDC systems. The systems must not only be cost-efficient, but also offer a high benefit in terms of data quality and process optimisation. There are clearly different requirements for studies with only 20 participants and 2 examination appointments or those with 2500 participants who are to be included in 4 months and subsequently have 5 follow-up visits with complex questionnaires and the desire for a retention rate of > 80%.

Integration and interoperability

The ability of EDC systems to integrate into existing IT infrastructures and other digital modules is crucial. The integration of sensor-based data, automatic assignment to intervention or control groups and automatic sending of access codes from medical apps are interesting.

Experience and network

MEDIACC utilises its many years of experience and its strong network to select the best EDC systems. Experience with various providers and co-operation with partners and institutions are incorporated into the decision-making process.

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Through this comprehensive analysis and consideration of the above factors, MEDIACC, as CRO on behalf of its sponsors, ensures that the selected EDC systems are optimally tailored to the needs of its customers and the requirements of the clinical studies.

Can we support you too? You are welcome to arrange a first non-binding appointment here.