Holistic, actionable, real-world insights
Designing and running studies that collect patient-reported and clinical data, powered through the Vitaccess Real™ platform
Our approach to RWE generation
Whether you need RWE to support regulatory and health technology assessment submissions, inform product positioning or characterize the impact of diseases and treatments – we can support your study from start to finish.
Our approach to generating RWE combines scientific and participant experience expertise, to enable optimal recruitment and engagement, and granular capture of robust, meaningful data.
Study design & protocol development
Dataset definition & PRO instrument selection
Site, community, or hybrid recruitment
Participant engagement & retention
Reporting & data visualization
Publications
1 . Study design & protocol development
Experts in Developing Scientifically Sound Real-World Study Protocols
We work collaboratively with our clients, patient groups, and clinical experts to design a study that addresses your evidence-generation needs.
We cover all ethics submissions, on both local and international levels.
30+
Approved Ethics / IRB Submissions
2 . Dataset definition and PRO instrument selection
Providing you with the best approach for collecting complete and quality patient-reported and clinical data
Using specialist technical knowledge we select the most appropriate patient, caregiver-reported outcome instruments, or develop bespoke questionnaires and CRFs for your study needs.
You’ll be covered from selection, licensing, and translation to electronic migration of validated patient-reported outcome instruments and customized questionnaires.
50+
ePROs instruments deployed in studies
Data standards such as CDISC, FAIR & more
3 . Site, community, or hybrid recruitment
Optimize recruitment strategy to meet study objectives
Reach patients, caregivers and clinicians through a variety of approaches to optimize recruitment.
Whether you require site-based recruitment or wish to opt for high accessibility with community recruitment via patient advocacy groups and social media networks – we can conduct studies that reach patients around the globe.
60+
relationships with patient associations & key opinion leaders
4 . Participant engagement & retention
Participation engagement expertise, boosted by the Vitaccess Real™ platform
Collect data from participants in a user-friendly and flexible way, with a simple online survey or a dedicated web application.
An engagement strategy personalized to the study cohort: participant compensation, charitable donations, newsletters, webinars, infographics, and competitions, combined with SMS and email notifications.
Over 90%
compliance in real-world studies
5 . Reporting & data visualization
Data to differentiate your product
Our in-house analytics team of expert statisticians and data scientists will ensure your data stand up to the scrutiny of regulators, payers, and other decision makers.
With our interactive online dashboards, you can also view and interact with your study data in real-time: track recruitment and engagement, explore hypotheses, or conduct ad-hoc analyses.
6 . Publications
Leverage your newly captured real-world data
From publication planning to delivery – we help you communicate the right data to the right audience at the right time.
We can support you with all aspects of publications development, disseminating your findings at national or international conferences or in peer-reviewed journals.
100+
publications
Trusted by our clients & partners
Syndicated registries
Our innovative multi-client syndicated registries improve the flexibility and speed of studies for researchers, sites, and patients by harmonizing study governance, design, and data collection, while adapting to study-specific research objectives and requirements.
Smart registries
Smarter by design. Our smart registries run alongside clinical trials or expanded access programmes, seamlessly capturing ePROs and real-world outcomes. The result is a single evidence engine with multiple applications – regulatory, market access, medical affairs, and commercial – keeping patients at the center while maximizing the value of every dataset.
Take a look at some of our study designs and outcomes
Generate RWE seamlessly with our platform — from eCOA/ePRO, eCRF, and eConsent, to EMR integration and interactive data dashboards — delivering deeper, faster insights into the impact of diseases and treatments.
Capturing micro-moments for accurate measurement of disease burden
- Charcot-Marie-Tooth disease patients experience a high risk of falls or near falls
- Accurate recall of falls or near falls is unlikely in retrospective surveys
- Patients can tap to record falls or near falls on in-app counter
- Same-day data
- Patients can review and share their history of falls or near falls with healthcare professionals
Understanding diversity: data collection beyond clinical sites
- Limited understanding of disease burden in advanced melanoma across UK
- Difficulty in retrospectively capturing pain – an important symptom in stage 3 and 4 melanoma – in medical consultations
- Data collected across the UK
- Daily recording of symptoms via an eDiary
- Distribution of patient support resources directed by UK-wide data, thus avoiding limitation to localized clinical sites
- Tracking of health journey via eDiary for personal use or as a resource for clinicians
Capturing longitudinal disease impact to support reimbursement submissions
- Myasthenia gravis disease burden due to residual symptoms, refractory disease, episodes of symptom exacerbation, and treatment side effects may not be accurately captured in clinic visits
- Bespoke app designed for longitudinal, observational study
- Profile section to capture demographic and past treatment information
- Tracker section to regularly capture disease burden and current treatment information
- Regulatory-ready evidence
- Faster insights across markets
Simplifying survey completion for participants
- In peanut allergy, exposure to allergens away from clinical sites is subject to recall and recency bias
- Data on patients not being exposed to the allergen is seldom routinely collected
- Weekly SMS survey administered to participants’ own devices asking whether they had been exposed to the allergen in previous week
- Only if participant responds ‘Yes’ do they provide further information on the exposure via an in-app survey
- Useful data collected with relative ease for participants
- In-app survey only completed by those with an exposure to report
Combining clinical and patient-reported data to drive therapy value proposition
- Indication with significant competition
- Regulators are focusing on HRQoL
- Clinical trials typically have insufficient follow-up for long term assessment
- Capture clinical data via eCRF: diagnosis, staging, treatment history, performance status; progression-free survival and treatment status updated every 90 days
- Capture patient-reported data via their smartphone app: generic and disease-specific PROs every 60 days
- Rewards module to drive longitudinal engagement
- Granular measurement of therapy’s value proposition
- End-to-end support of design, launch, management, analysis and dissemination
Power your studies through the Vitaccess Real™ platform
Generate real-world evidence seamlessly with our platform — from eCOA/ePRO, eCRF, and eConsent, to EMR integration and interactive data dashboards — delivering deeper, faster insights into the impact of diseases and treatments.
Frequently Asked Questions
RWE is becoming increasingly important in understanding how treatments work outside the controlled setting of clinical trials. Observational or non-interventional studies play a crucial role here, capturing data directly from patients, caregivers, clinicians, and medical records to build a more complete picture of disease and treatment outcomes.
We’ve answered some of the key questions we’re often asked.
What exactly is an observational study/non-interventional study?
An observational study (sometimes called a non-interventional study) is designed to collect data on patients in real-world settings, without altering their treatment. Unlike clinical trials, patients continue with their usual care, and we observe outcomes, experiences, and treatment pathways over time.
How is RWE different from clinical trial data?
Clinical trials provide controlled, highly specific data, but typically from narrow patient groups under tightly managed treatment pathways, which don’t reflect everyday clinical practice. RWE complements this by showing how treatments perform in routine care, across diverse populations, healthcare systems, and geographies. Together, data from both clinical trials and the real-world setting provide a fuller picture for decision-making.
How can observational studies be used in regulatory or market access contexts?
Observational studies can support a wide range of regulatory and market access needs, such as mapping disease burden and progression; complementing or addressing gaps in clinical trial data with patient- or caregiver-reported outcomes; strengthening a product’s evidence base during an early access or post-launch period with broader, more diverse, or long-term data. Data from observational studies can give stakeholders confidence that decisions are based on evidence grounded in real-world care.
Key to the successful use of observational real-world data in regulatory and HTA settings are adherence to the evidence requirements of the decision-making body in question, comprehensive and transparent analysis and reporting, and compliance with relevant governance frameworks. Study design and analysis should ensure that data are relevant, bias is minimized, and uncertainties are addressed where possible.
How do you ensure data quality and reliability in observational studies?
We apply rigorous scientific methods and governance frameworks at every stage — from study design and data collection to statistical analysis and reporting. By combining strong knowledge of relevant stakeholder guidelines and preferences, methodological expertise, and our in-house RWE platform, we deliver robust, defensible datasets that stand up to scrutiny from regulators, HTA bodies, and payers.
What role do patients play in developing your studies?
We design studies in collaboration with patient communities and advocacy groups wherever possible, ensuring that participation is meaningful, convenient, and engaging. We like to involve patient representatives in reviewing study outcomes and participant-facing materials, spreading word of the study through their networks, being co-authors on our publications, and more. This approach consistently delivers strong levels of recruitment and compliance, fosters good relationships with the patient community for future collaboration and research, and ensures that the evidence generated in our studies truly reflects the lived experiences of patients and caregivers.
