There is an increasing drive and focus on the collection and use of Real World Data (RWD) within pharmaceutical research and development. With advances in technology and the advent of personalised medicine, the demand for real world data to support the drug development lifecycle continues to gain momentum as well as support from regulatory agencies.
Advances in technology and the advent of personalised medicine have made it feasible to collect more detailed data, from more subjects, more frequently and in real world settings. This extends to the possibility that a subject may not even need to visit the Investigational Site in person. With more detailed data, available more quickly, sponsors can maximise efficiency and speed their decision making throughout the drug development life cycle.
Cmed supports such real world studies and helps to connect sponsors working on new therapies with the patients who benefit from them. By collecting, analyzing and interpreting the data you need, we can bridge the knowledge gap between clinical trials and clinical practice.
Here’s how Cmed can help your Real World study:
- Proven scalability and management of large data volumes
- EMRs, imaging data, biomarkers, lab data, wearable sensors, data from pharmacy, registries, even social media provide large new sources of real world data that, when properly managed, assimilated and analysed, can shed more light on the use and safety of new therapies as well as treatment patterns and disease progression.
Cmed routinely works on Real World studies with large data volumes or data collection from many data sources:
- Single large studies with hundreds or thousands of patients
- Prospective or Retrospective Observational studies
- Expanded or Early Access Programs (EAPs)
- PASS (Post Authorisation Safety Surveillance)
Our team of Real World Data Specialists
Strategically located around the globe, our Real World specialists work to successfully design and execute studies of any size or objective. Our fit-for-purpose operational approach delivers high quality results with every project.
Focus on Data Quality
Credible real world evidence is only generated from high quality data that is obtained from relevant real world data sources, that is harmonized and includes endpoints.
Quality data must be traceable/auditable, complete, transparent, generalizable, timely, and scalable. Cmed will work to develop such standards in close collaboration with biopharmaceutical companies and Real World data providers.
- Training sessions on processes organised for local data coordinators, data managers and data custodians as applicable.
- Automated data quality checks and visual prompts in place at data entry to prevent introduction of erroneous or inconsistent data .
- Standard data quality control reports produced at local level to check for missing, unusual or incorrect data; source data verification through manual checks of medical charts or records to be performed secondarily.
- Indicators of data quality are measured periodically
encapsia - Technology designed and built for the real world
Encapsia is Cmed’s proprietary EDC system to collect, analyze and manage clinical trial data. Encapsia addresses the limitations of other systems with Real World Data collection including:
- Linking with external data sources is straightforward with encapsia’s API integrations
- Data collected, uploaded or fed into encapsia by integrations can be explored and analyzed in real time with inbuilt visualizations and insights
- Encapsia is built to make use of modern architectures and cloud hosting to provide for easy scaling and handling of large data volumes
- Encapsia supports mid-study design changes with no downtime for end users
- Encapsia has AI compatibility to support rapid and high volume analysis of data
RWD studies typically have infrequent on-site monitoring since there is no IP involved and data is collected as part of routine practice.
This is where Cmed’s Data Management and Analytics teams take a lead role in defining metric reports to monitor performance and progress at site level. Encapsia has remote monitoring capabilities and is able to trigger, target and track data monitoring and review to optimize use of site visits.
Go to Monitoring Models page.
Cmed’s Approach for Real World Studies:
- Flexible team structures adapt to study design changes and sponsor needs
- Powerful modern system architecture designed for speed and scalability
- Rapid incorporation of multiple data sources (eg ePRO, Laboratory Data)
- Key progress updates and summarization of study metrics for easy oversight
- Real time visibility of clinical data and status
- System flexibility supporting complex design requirements and seamless mid-study changes