Real World Evidence and Data

PVR’s real-world evidence (RWE) and real-world data (RWD) services focus on harnessing healthcare information derived from various sources outside typical clinical research settings.

These services help in improving decision-making and patient care by leveraging data acquired from sources like electronic medical records, claims and billing data, and patient registries.

The use of RWE and RWD has become increasingly integral in the pharmaceutical industry, supporting regulatory decisions, advancing disease understanding, and assisting in outcome-based reimbursement decisions.

REAL WORLD
Evidence & Data

real-world data services

Real World Evidence
and Real World Data

RWE & RWD helps to uncover new research insights from social, demographic and geographic diversity, using tailored technical solutions for clinical research.  The fit-for-purpose data allows to achieve faster results and find more benefisial outcomes typically not appearing during the classical clinical trial
RWE Consulting - Strategy
RWE Study Design
RWE Regulatory - Facing Support
Out-of-sample Synthetic data generation;
Natural History Study(non-interventional/observational)
Clinical Trial with External Control Group (ECG)
real-world data services

Humanitarian expanded access

If the patient has exhausted all available treatments, a clinical trial isn’t an option, Expanded Access Program provides a pathway to the pre-approved investigational drug and can safe patient's life.
MoH and EC submissions
Investigator dossier preparation
Site Management
CRA training
Adverse Events Management and Reporting
Importation and Delivery Support
RWE & RWD helps to uncover new research insights from social, demographic and geographic diversity, using tailored technical solutions for clinical research.  The fit-for-purpose data allows us to achieve faster results and to find more benefisial outcomes typically not appearing during the classical clinical trial
RWE & RWD helps to uncover new research insights from social, demographic and geographic diversity, using tailored technical solutions for clinical research.  The fit-for-purpose data allows us to achieve faster results and to find more benefisial outcomes typically not appearing during the classical clinical trial
RWE consulting - strategy
RWE study design
RWE regulatory - facing support
Out-of-sample synthetic data generation
Natural history study (non-interventional/observational)
Clinical trial with external control group (ECG)
If the patient has exhausted all available treatments, a clinical trial isn’t an option, Expanded Access Program provides a pathway to the pre-approved investigational drug and can safe patient's life.
MoH and EC submissions
Investigator dossier preparation
Site management
CRA training
Adverse events management and reporting
Importation and delivery support

What is the difference between RWE and RWD?

Real-world data (RWD) refers to data concerning patient health status or the delivery of healthcare that is routinely collected from various sources. Real-world evidence (RWE), on the other hand, is the clinical evidence regarding the use and potential benefits or risks of a medical product derived from the analysis of RWD.
Essentially, RWD provides the raw information, while RWE is the insight or knowledge gained from analyzing that data.

What is the role of RWE & RWD in digital medicine?

In digital medicine, RWE and RWD play a pivotal role by providing actionable insights into patient health and the effectiveness of treatments in real-life scenarios, beyond what is observed in controlled clinical trials.
These insights help in understanding disease patterns, treatment outcomes, and patient behavior in a more comprehensive manner.
They aid in personalizing patient care, improving treatment strategies, and making informed healthcare decisions, significantly contributing to the advancement of digital health solutions.

OTHER CLINICAL SERVICES

Clinical Trial Research and Development
Read More
Patient Focus
Read More
Data management and AI solutions
Read More
Biospecimens
Read More