Regulatory authorities such as the FDA and EMA are increasingly stressing the importance of timely post-market studies in order to determine the safety and efficacy of drugs already on the market in order to update drug labelling if necessary.
In the medical device sector, regulatory authorities are putting pressure on companies to prove the safety of a device in use and are requiring more post-market study data. In particularly in the EU, in an effort to guarantee patient safety, more PMCF (Post-Market Clinical Follow-up) studies and safety surveillance has been proposed including harmonization among EU member states in terms of market surveillance.
Therefore, how can companies conduct their post-market studies in a cost-effective manner while meeting the “timely” demands of regulatory authorities?
CROS NT suggests effective techniques for managing post-market study data that will guarantee cost control, efficiency and regulatory compliance.
1. Implementing data management strategies for the management of vast amounts of data from large patient populations.
The use of a Global Library can significantly reduce DM costs by re-using forms – cost reductions of up to 50% if implementing the centralized biometrics outsourcing model. This guarantees a uniform traceability of data, due diligence ready datasets and documentation as well as one single Project Manager.
2. Implementing and/or Mapping to CDISC standards for regulatory acceptance
It is important to start implementing CDISC standards during data collection by having Data Managers design the CRF using CDASH standards. This makes the process of mapping data into SDTM and ADaM datasets much more straightforward. Identifying the right process for implementation and choosing the appropriate technology can reduce the costs of adopting these standards.
3. Implementing technology solutions such as eClinical platforms with EDC/ePRO/IWRS/CTMS in order to collect and analyze data in real time.
Biostatisticians need to be able to make crucial and informed decisions. An eClinical, cloud-based solution allows for real time study management, access to data from any device and flexibility of contracted resources. Using the same ePRO/EDC/IWRS reduces set-up, training and HelpDesk costs and allows for easy data integration.
With cloud-based eClinical applications, key performance indicators and the creation of clear Service Level Agreements with CROs becomes more achievable.
4. Implementing clinical data visualization tools that allow Sponsors to make sense of clinical data immediately.
The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze data immediately and using that data to identify and fix problems.
Business Intelligence tools are the best technology option for Data Visualization, especially if implementing a Risk-Based Monitoring approach. They allow for data retrieval, report development from different data sources, report delivery and cloud-based technology. Web-based applications can be accessed from various devices including PCs/laptops, smartphones and tablets.
Have an upcoming post-market study in the drug or device development cycle? Contact CROS NT for clinical data and technology solutions that fit your study and budget needs.