Retrospective Data Collection and Collation
No matter what style of study you wish to conduct, nearly all can be enhanced through the collection of data from ‘a’ patient’s EHR record. Through our partners we can extract, transform and collate data from patient primary, secondary and tertiary care records. This can be used:
- Directly for retrospective or hybrid studies
- To support accurate feasibility assessments,
- To supplement (prefilling) patient histories
- For eCRF data for prospective studies.
eCRF Development and Management
Building a suitable eCRF for a study, incorporating the views of all the stakeholders, can help improve data quality. By working with our partners we are able to create an interface that works for the nurse in the clinic, the study team in the office and the researchers conducting the analysis.
We also offer optional services such as eCRF write back into the patient EHR record and auto filling patient histories and medications into the eCRF from their EHR.
Data Collection Methods to Support Effectiveness and RWE Studies
Our experience in effectiveness studies and close collaboration with data providers has allowed us to monitor patients directly using their EHR. This technology allows patient’s data to be received each time they visit their GP, hospital or even their pharmacy when participating in the study. This data can be collected to identify healthcare utilisation, monitor patient safety and identify specific study endpoints.
This data can be extracted daily allowing patients to be closely monitored without intervention which helps maintain the real world methodology. Such close monitoring also allows potential safety events to be identified close to real-time, ensuring patient safety is maintained. This technology allows for robust safety monitoring and data collection and can be applied to difference disease areas and treatments, as well as geographical locations. The growing use of electronic data provides a considerable un-tapped resource for monitoring and capturing safety data in clinical trials, allowing more comprehensive and accurate safety data to be collected. It is also possible with this technology to integrate data from wearables and social media, to create a truly holistic view of the patient.
Monitoring and QA/QC
Creating a detailed monitoring plan at the outset of the study is a key to success. Our team are able to support the planning design and implementation of a monitoring plan that is fit for purpose.
CK Aspire is the first company to build and maintain a unique team of Safety Nurses. This dedicated team have extensive experience in collaboration with data providers and are able to monitor and report safety events close to real time using innovative IT solutions. The team is able to review and triage safety events and provide support to GP investigators. Because of our extensive experience with this type of novel research methodology we offer a unique skill set to run a prospective effectiveness study of this type.
Effectiveness studies have a broad inclusion criteria’s and subjects are recruited with complex co-morbidities, and are expected to experience multiple serious adverse events (SAEs) generating a large volume of safety data. Models using the safety nurse role can support the research teams with high volumes of SAEs, which enables the research nurse to focus on meeting recruitment targets.
For more information on any of these services click here to contact us