Gaining regulatory approval does not always depend on including clinical site data within your regulatory submission. Regulatory agencies have increasingly acknowledged the value of real world evidence (RWE) in providing insights into the safety and effectiveness of drugs outside of controlled clinical trial settings. Advances in technology, such as electronic medical records (EMR), wearables, and sensors, have facilitated the collection of real world data (RWD). This increased availability of data from diverse sources, including registries and healthcare databases, has expanded the opportunities for leveraging real world evidence in clinical trials and real world studies.

At Quanticate our team of experts has 115 years combined of experience in Real World Data, acquired while working across multiple Therapeutic Areas (Oncology, Rare Diseases, Vaccines, Inflammation & Immunology, Internal Medicine, Infectious Diseases). Our team can provide your organization with their expertise on topics such as new drug/device safety and efficacy, health economic outcomes research (HEOR) and observational studies.

Our RWE Capabilities Include:

• Ability to handle, capture, clean and process large volumes of data within our CDM group
• Experience in patient, drug, and pregnancy registries
• Non-interventional and low-interventional observational studies
• Pragmatic clinical trials
• Post-approval safety studies
• Long-term outcome and survival studies
• Phase IIIB / IV clinical trials
• Elicitation of historical control data for rare diseases
• Validation of novel endpoints that are more relevant for the patient
• Measuring presence of a disease in a population, (prevalence/incidence)
• Tracking usage of given drug among selected population across years, (drug adherence/ persistence)
• Comparing selected drugs
• Analyzing Health Care Resource Utilizations and costs, (HCRU, medical inpatient and outpatient costs)
• Analyzing potential clinical trial population
• Comparing case and control cohorts, (propensity score matching, case-control matching)
• Analyzing treatment patterns (persistence on given drug, switches to competitors, uses of generics)
• Conducting sponsor’s specific analysis

Connect with us today!

As you explore the possibilities in RWE, Quanticate’s global team of experts are here to support as your trusted partner. From patient profiling to streamlined trial processes, we bring a wealth of expertise and a dedication to transforming Real World Evidence into success.
Unlock the full potential of your Real World Evidence journey — choose Quanticate, the leading Real World Evidence CRO.