This May, Michele Montanari, our Life Science Applications Manager, joined “Hot Topics from ACDM” as Session Lead.
“Hot Topics from ACDM” is a new innovative format of online discussion appointments by the Association for Clinical Data Management.
Michele was leading a session titled “How to Integrate a Complex Clinical Oversight Solution” that took place on the 27th of May.
About the session “How to Integrate a Complex Clinical Oversight Solution”
ICH GCP E6 (R2) introduced new guidelines that increased the responsibility of the sponsor when it comes to outsourcing the activities to the CROs. However, 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 use an oversight solution effectively, granting data quality, analysis and resources optimisation, the sponsors need to smoothly integrate it with the CTMS of their CROs. Despite the advantages of having an oversight solution, its integration can be daunting for the sponsor’s staff.
The most common challenges include:
- Data mapping, which is often time consuming, very hard to keep up to date and risky as chances to lose important information are high
- Management of a high number of different stakeholders (customer, technology and consulting supplier, CROs), different professional figures and departments where each of them has their own requirements, needs and project expectations
- Integrating not only technologies but new processes in the company framework, managing the trainings and the change management process in order to ease the transition period
What did participants learn?
This Hot Topic session will cover the ways of overcoming the most common challenges in the integration of the complex clinical oversight solution. We will discuss the key integration steps – planning, risk management, efficient tests, processes, and stakeholder communication and provide suggestions on how each of these steps can be conducted in an effective manner.