Real-World Evidence generation
Market Access, Commercial Strategy & implementation
Real-World Evidence generation
Payers are increasingly seeking clinical and economic evidence that applies to their beneficiaries. Clinical trial data are often limited to selected populations and are unrepresentative of actual use. Pragmatic studies in real-world settings provide data that truly reflect target populations in current clinical practice.
We have extensive experience in conducting pragmatic trials in both hospital and ambulatory settings. Whether your needs range from a prospective real-world study to a retrospective research of Electronic Medical Records (EMRs), data linked to medical and pharmacy claims or global data sources, ECONCARE can help.
These studies enable gathering data for various HEOR measures like:
- clinical effectiveness of treatment,
- patients’ quality of life and other patients reported outcomes (PROs),
- patients adherence/persistence to treatment,
- patients satisfaction with treatment,
- resource utilization and cost.
These data can be used:
- in economic evaluations of real-world drug use; economic evaluations based on pragmatic study results are better adapted to payers’ needs,
- to provide understanding of real-world treatment patterns,
- to estimate humanistic and economic burden of illness,
- to determine demographic and clinical characteristics of patients with a given disease;
- to calculate treatment adherence
- to determine potential factors related to treatment adherence and persistence;
According to the needs of each project, we can contribute in:
- Study design and protocol writing
- eCRF or paper CRF development
- Patients informed consent forms development
- Database development
- Statistical analysis plan development
- Data entry and validation
- Data management
- Sample size calculation
- Statistical analysis
- Development of study report and communication support (abstracts, posters, manuscripts)
Prospective studies are conducted to measure outcomes related to disease epidemiology, treatment patterns, real-world safety and effectiveness, or burden of illness. EconCare employs a wide variety of prospective methods such as interviews, surveys or clinical data collection, among physicians, patients, or decision makers in order to deliver high quality results. Our Team has the ability to design and conduct observational, non-interventional, pragmatic and patient registry studies and provide full-service support for prospective studies.
- Patient registries
- Phase IV RCTs
- Economic Analyses Alongside Clinical Trials
- Patient-Reported Outcomes (PROs)
- Quality-of-Life (QoL) Analyses
- Time and Motion Studies
- Clinical Outcomes
- Prospective Data Analysis
- Hybrid Prospective Study (existing data + primary data collection)
Retrospective studies can help you to evaluate the disease burden and cost, compare the performance of marketed products and explore market opportunities for targeting a new product. Healthcare databases provide a wealth of information that can be used to assess retrospectively the aforementioned. The experts of EconCare have extensive experience in retrospective database analyses like:
Chart review design/analysis
We perform efficient and accurate chart studies that provide valuable sources of information on topics such as disease epidemiology, treatment patterns, and survival and health outcomes. We have successfully conducted chart reviews in multiple disease areas in Greece.
Claims database analysis
We are able to extract and use data from claims made to health care insurance companies on patients’ behalf to conduct epidemiological, treatment pattern, economic burden, and clinical outcomes research.
Electronic medical records (EMR) and hospital databases
We utilize EMR databases such as IMS databases to perform a variety of analyses. We also have a lot of experience in dealing with hospital data to examine inpatient procedures.