Vitaccess RWE logo

Power your studies through the Vitaccess Real™ platform

Obtain deeper, faster insights into the impact of diseases and treatment in the real world.

Study apps

Our approach to RWE generation

Our six step approach to end-to-end real-world evidence study design and delivery

1 . Study design & protocol developmentl
2. Dataset definition & PRO instrument selectionR
3. Site identification or hybrid recruitment
4. Participant engagement & retention
5. Reporting & data visualization
6. Publications i
Experts in developing scientifically sound real-world study protocols for optimal participant experience

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 user experience with scientific expertise to enable optimal recruitment, engagement, and granular data capture. We cover all ethics submissions, on both local and international levels.

approved ethics / IRB submissions

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 (including 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.

ePROs instruments deployed in studies

cdisc logo

Data standards such as CDISC, FAIR & more

Optimize recruitment strategy to meet study objectives

Reach patients, caregivers and clinicians through a hybrid approach to optimize recruitment to meet study objectives.

Whether you require site-based recruitment or wish to expand the reach and 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.

relationships with patient associations & key opinion leaders

Deploying the Vitaccess Real™ RWE user-friendly platform to keep participants in your study

Collect data from participants in a user-friendly and flexible way, with a simple online survey, smartphone app or linking clinical data with participant data via the Vitaccess Real™ platform.

Initiatives to boost retention such as newsletters, webinars, infographics, competitions, and rewards, combined with SMS, email, and push notifications – you can personalize each strategy to the study cohort. 

languages to reach participants worldwide

weeks platform configuration start-up time

View your study data via real-time dashboards for exploring hypotheses or ad-hoc analyses and reporting

Data to help you differentiate your product to payers, providers, and policymakers – we can help provide real-world evidence complementary to clinical trial data suitable for submission to regulators such as the FDA and EMA, or HTA and pricing and reimbursement agencies such as ICER and NICE.

Group of devices
Leverage your newly captured real-world data as abstracts, posters, and manuscripts – we employ the best practices needed for successful publications.

From publication planning to delivery – we help you communicate data to the right audience at the right time with unparalleled expertise. We can support you with presenting study findings at a range of national and international conferences.

publications

Take a look at some of our study designs and outcomes

Our patient-centric real-world evidence studies powered by the Vitaccess Real™ platform enable you to obtain deeper, faster insights into the impact of diseases and treatment in the real world.

Pharnext_PNGlogo
Melanoma_PNGlogo
Argenx
Aimmune logo
CMT patient registry
Diverse primary data capture
Global rare disease registry
Capturing micro-moments
Site-based RW study

Capturing micro-moments for accurate measurement of disease burden

Challenge
  • 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
Solution
  • Patients can tap to record falls or near falls on in-app counter
Value
  • Same-day data
  • Patients can review and share their history of falls or near falls with healthcare professionals
CMT&Me app screenshot - falls tracker

Understanding diversity: data collection beyond clinical sites

Challenge
  • 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
Solution
  • Data collected across the UK
  • Daily recording of symptoms via an eDiary
Value
  • 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
Melanoma app

Capturing longitudinal disease impact to support reimbursement submissions

Challenge
  • 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
Solution
  • 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
Value
  • Broad, routine, granular data capture on longitudinal disease impact and treatment needs
  • Data used to prepare market for product launch and to support reimbursement submissions
MG study app screenshot

Simplifying survey completion for participants

Challenge
  • 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
Solution
  • 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
Value
  • Useful data collected with relative ease for participants
  • In-app survey only completed by those with an exposure to report
Study text message image

Combining clinical and patient-reported data to drive therapy value proposition

Challenge
  • Indication with significant competition
  • Regulators are focusing on HRQoL
  • Clinical trials typically have insufficient follow-up for long term assessment
Solution
  • 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
Value
  • Granular measurement of therapy’s value proposition
  • Rigorous data suitable for publication and diverse audiences
  • End-to-end support of design, launch, management, analysis and dissemination

Full Service Offering

In-house design & implementation combining multidisciplinary expertise with our next-generation Vitaccess Real™ platform

Experienced

Thousands of patient and caregiver participants already recruited across many indications

Global

Rigorously localized studies in North America, Europe and Asia

Flexible

Customizable modular platform enabling tailored study design

Secure

Gold-standard data security, GDPR and HIPAA compliant, ISO 9001, 27001 and 17100 certified

 

Perk

Patient-centric

Multi-stakeholder co-creation with patient groups and clinical experts, enabling an inclusive methodology and patient-relevant data collection

📣

New White Paper

How to collaborate with patients to develop a patient-centered study

Real data. Patient progress.

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