Life science
REAL-WORLD DATA
COLLECTION
Monsenso enables the remote collection of patient-
generated data and device-generated data from
clinical, post-approval to real-world studies.
POWERING REAL-WORLD EVIDENCE STUDIES
The Monsenso solution empowers CROs and pharmaceutical companies to capture real-world data, revealing patient insights that could enhance a trial’s efficacy and speed up the drug development process.
Our agile, evidence-based solution enables you to remotely assess all your subjects 24/7 across the product life cycle.
Our digital health solution enables the remote collection of patient-generated data and device-generated data from clinical, post-approval to real-world studies.
Monsenso is a CE Class 1 medical device that securely captures patient-generated data using ePRO and a suite of sensors and wearables to provide a more holistic view of patients’ journey.
Real-World Evidence generation
Monsenso enables real-world evidence (RWE) generation through patient-generated & device-generated data collection across the product life cycle.
Clinical Development
Enable patient-centred drug development with our solution to impact outcomes that matter to patients. Our evidence-based solution is developed with and for patients with mental health and psychiatric conditions to reduce their burden of contributing to research.
Post-Market Studies
Equip global, multi-centre, non-interventional, longitudinal studies with our solutions to measure safety and efficacy, describe patient, drug use, and clinical development across treatment pathways in real-world medical and clinical practice for regulators.
Companion Products
Engage patients with our solutions to enable personalised care, education, self-management, behavioral change, symptom and disease progression monitoring, and medication adherence. Demonstrate value to patients, prescribing physicians and payers.
Digital Biomarkers, Digital Therapeutics & Personalised Medicine
Enhance the development and validation of digital endpoints, biomarkers, therapeutics, and pharmacogenomics testing in the real-world setting using our capabilities for continuous stream of active and passive patient data capture.
HOW OUR SOLUTION SUPPORTS REAL-WORLD STUDIES
MOBILE APP
eConsent
Enable participants to understand the study and their role, and to provide informed consent to take part remotely.
ePRO
Track participant data using clinical questionnaires, eDiary, Ecological Momentary Assessments together with sensor based data and data on usage-patterns.
Visualisation and feedback
Enable trial participants to follow their progress through visualisations and to get motivational feedback improving protocol compliance.
Direct messaging
Provide timely support to participants remotely, reducing the number of unplanned site visits and potential dropouts.
Medication reminders
Provide patients with information on their medication, reminders to promote adherence and access care at home or in-clinic.
Protocol Reminders
To ensure protocol compliance, study participants receive notifications and reminders to complete study tasks and site visit.
Patient engagement tools
Engage trial participants through challenges, tools and psychoeducational materials to promote treatment compliance and reduce drop-outs.
Platform integration
Based on open standards allowing to integrate with a wide range of data sources, such as connected devices, wearables, and phone sensors.
Web portal
Easy recruitment
Send screening questionnaires, invite trial participants remotely with customised study information and assign trial participants to groups and protocols.
Investigator forms
Record HCP/ investigator notes or observations throughout the study (coming soon).
Direct messaging
Provide timely support to participants remotely, reducing the number of unplanned site visits and potential dropouts.
Site dashboard and Visualization
See individual trial participant adherence to the study plan and get insights into health outcomes through historical aggregation of health and behavioural data.
Audit trail
Get full traceability of the “who”, “what” “when” and “where” during your studies (coming soon).
Platform integration
Based on open standards that allow integration with a variety of data sources, such as connected devices, wearables, and phone sensors.
The opportunity in real-world data collection
Real world data capture
While RCTs are critical to determining the safety and efficacy of a treatment on a defined population within a controlled design, the usage, safety, and effectiveness of a treatment within a more heterogeneous population in the real-world remains to be demonstrated to regulators[1] and payers[2].
Our solution
Our platform empowers RWE generation through the remote collection of patient-generated and device-generated data across the product life cycle on patients’ safety, quality of life, as well as functional outcomes critical to regulators and payers.
Value-based agreements
As value-based contracting becomes more common, especially for costly and prevalent mental health conditions, understanding the value of drugs to patients is crucial. Most EHRs lack patient-reported outcomes on symptoms, functions, treatment adherence and quality of life, missing critical information from the patient’s perspective[3] that could demonstrate the success and value of a treatment[4].
Our solution
Through remote collection of patient-reported outcomes on symptoms, functions, treatment adherence and quality of life in real-world settings, our platform enables Life Sciences companies to demonstrate the real-world value of their medication to payers and providers.
Medication adherence
About half of patients with major psychiatric conditions, such as schizophrenia, major depressive disorders and bipolar disorders, do not adhere to their medication[7]. This delays recovery, increases the risk of hospitalisations and length of hospital stays, costing billions to payers[8].
Our solution
Our digital companion solution provides patients with information on their medication, reminds them to take their medication, and guides them along their treatment plan to promote patient engagement, adherence, and recovery.
New drug launches
About 2/3 of new drugs fail to meet sales expectations in the first year on the market[5]. Nearly half of these launches failed due to a lack of understanding of treatment responders or types of HCPs who would be high or low prescribers for the new drug, or underestimation of the difficulty to convert patients and HCPs from existing treatments, especially when generics are available[6].
Our solution
Our digital companion solution allows remote patient monitoring to identify treatment responders, educate clinicians and patients about the new medication and demonstrate its value based on real-world patient-generated data on quality of life and functional outcomes.
BENEFITS OF WORKING WITH US
Therapeutic expertise
7 years of clinical experience within mental health and psychiatric disorders, amongst others: depression, bipolar disorder, anxiety, schizophrenia, borderline personality disorder, addiction and substance abuse.
Track record
Extensive track record in global deployment within academia, healthcare, social care and pharmaceutical companies across a variety of mental health disorders.
Scalable for fast deployment
A configurable, customisable cloud-based/SaaS solution, that can be quickly configured to meet the needs of the target patient population and care pathway.
Regulatory, data privacy & security
Protocols designed to meet regulatory requirements. CE-marked as Class 1 Medical Device, Cyber Essentials certified and ISO 13485 and ISO 27001 compliant.
REQUEST A DEMO
Our expert team is ready to demonstrate the Monsenso real-world data collection solution and to answer any questions you might have.
References
[1] FDA: Https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
[2] Roberts, M.H., Ferguson, G.T. (2021). Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions. PharmacoEconomics Open 5, 3–11. https://doi.org/10.1007/s41669-020-00221-y
[3] Calvert, M.J., O’Connor, D.J., & Basch, E.M. (2019). Harnessing the patient voice in real-world evidence: the essential role of patient-reported outcomes. Nature Reviews Drug Discovery, 18(10), 731-732.
[4] Bourke, A., Dixon, W.G., Roddam, A., et al (2020). Incorporating patient-generated health data into pharmacoepidemiological research. Pharmacoepidemiology and Drug Safety, (12):1540-1549. DOI: 10.1002/pds.5169.
[5] Semahegn, A., Torpey, K., Manu, A. et al. (2020) Psychotropic medication non-adherence and its associated factors among patients with major psychiatric disorders: a systematic review and meta-analysis. Systems Reviews 9, 17 . https://doi.org/10.1186/s13643-020-1274-3
[6] Sun SX, Liu GG, Christensen DB, Fu AZ. Review and analysis of hospitalization costs associated with antipsychotic nonadherence in the treatment of schizophrenia in the United States (2007). Current Medical Research Opinion.(10):2305-12. doi: 10.1185/030079907X226050. PMID: 17697454.
When you have a mental illness you need to pay attention to your lifestyle in order to have a good life. Monsenso is very helpful, it reminds me to take my medication and provides me with an overview of my triggers and warning signs”
Patient with bipolar disorder