Phenotyping Patients to Increase the Precision of Clinical Trials
EMA Wellness was founded by scientists and industry leaders in 2018 to design and collect Ecological Momentary Assessment (EMA) data because we believed sponsors were missing critical, real world / in the moment data between site visits. In the subsequent six years, sponsors asked us to expand our platform to collect all data generated from patients, wearables, clinicians and observers, in the clinic and in the real world. The result is that our technology enabled science platform is the only system purpose built to collect eCOA, EMA and digital marker data – from anywhere, regardless of trial design – with the objective of improving patient centric, precision outcomes in clinical trials.
We Focus on Evidence and Science
- Real time data on compliance/adherence, ratings quality and eligibility criteria improves study data quality, subject selection and outcomes precision
- We have a deep focus on neuro psychiatric conditions
- Our experience of designing and implementing EMA integrated trials to meet bespoke study objectives is unparalleled and key to measure meaningful change and separation
Integration of EMAs, eCOA, eDiaries, and digital data in a single platform
- We are the only singular technology platform purpose built to collect both in the clinic and real world data – we are SSO, web based, device agnostic, and integrate audio/video interview and recording functions
- We can start up our platform in 2-4 weeks and have the flexibility to meet protocol amendments in less than a week
- We fully integrate all functionality throughout the trial (and across trials for registered raters), including flags and alerts, rater training, rater surveillance, central ratings, and outcomes analytics
EMA unlocks powerful insights into relationships between COA and digital data
- Data security compliant with FDA and GDPR guidelines
- Data visualization in near real time to show compliance, enhance subject selection, and measure meaningful change
- Clean data collection for prospective and retrospective data analysis
Purpose-built to meet study needs and budget:
- Single vendor to manage all in clinic and real world generated patient related data collection (e.g. eCOA, sensor, observer, patient)
- Purpose built technology platform passes on substantial cost savings to sponsor partners
- Single integrated platform to meets short activation timelines with agility to adhere to protocol amendments in days
- Legacy platforms have poorly integrated, antiquated, disparate technology which drives unnecessary maintenance costs, operates at slow speeds, and embeds too many patches
Integration of EMAs, eCOA, eDiaries, and digital data in a single platform
- We are the only singular technology platform purpose built to collect both in the clinic and real world data – we are SSO, web based, device agnostic, and integrate audio/video interview and recording functions
- We can start up our platform in 2-4 weeks and have the flexibility to meet protocol amendments in less than a week
- We fully integrate all functionality throughout the trial (and across trials for registered raters), including flags and alerts, rater training, rater surveillance, central ratings, and outcomes analytics
EMA unlocks powerful insights into relationships between COA and digital data
- Data security compliant with FDA and GDPR guidelines
- Data visualization in near real time to show compliance, enhance subject selection, and measure meaningful change
- Clean data collection for prospective and retrospective data analysis
Purpose-built to meet study needs and budget:
- Single vendor to manage all in clinic and real world generated patient related data collection (e.g. eCOA, sensor, observer, patient)
- Purpose built technology platform passes on substantial cost savings to sponsor partners
- Single integrated platform to meets short activation timelines with agility to adhere to protocol amendments in days
- Legacy platforms have poorly integrated, antiquated, disparate technology which drives unnecessary maintenance costs, operates at slow speeds, and embeds too many patches
We Focus on Evidence and Science
- Real time data on compliance/adherence, ratings quality and eligibility criteria improves study data quality, subject selection and outcomes precision
- We have a deep focus on neuro psychiatric conditions
- Our experience of designing and implementing EMA integrated trials to meet bespoke study objectives is unparalleled and key to measure meaningful change and separation
EMA unlocks powerful insights into relationships between COA and digital data
- Data security compliant with FDA and GDPR guidelines
- Data visualization in near real time to show compliance, enhance subject selection, and measure meaningful change
- Clean data collection for prospective and retrospective data analysis
Purpose-built to meet study needs and budget:
- Single vendor to manage all in clinic and real world generated patient related data collection (e.g. eCOA, sensor, observer, patient)
- Purpose built technology platform passes on substantial cost savings to sponsor partners
- Single integrated platform to meets short activation timelines with agility to adhere to protocol amendments in days
- Legacy platforms have poorly integrated, antiquated, disparate technology which drives unnecessary maintenance costs, operates at slow speeds, and embeds too many patches
We Focus on Evidence and Science
- Real time data on compliance/adherence, ratings quality and eligibility criteria improves study data quality, subject selection and outcomes precision
- We have a deep focus on neuro psychiatric conditions
- Our experience of designing and implementing EMA integrated trials to meet bespoke study objectives is unparalleled and key to measure meaningful change and separation
Integration of EMAs, eCOA, eDiaries, and digital data in a single platform
- We are the only singular technology platform purpose built to collect both in the clinic and real world data – we are SSO, web based, device agnostic, and integrate audio/video interview and recording functions
- We can start up our platform in 2-4 weeks and have the flexibility to meet protocol amendments in less than a week
- We fully integrate all functionality throughout the trial (and across trials for registered raters), including flags and alerts, rater training, rater surveillance, central ratings, and outcomes analytics
Purpose-built to meet study needs and budget
- Single vendor to manage all in clinic and real world generated patient related data collection (e.g. eCOA, sensor, observer, patient)
- Purpose built technology platform passes on substantial cost savings to sponsor partners
- Single integrated platform to meets short activation timelines with agility to adhere to protocol amendments in days
- Legacy platforms have poorly integrated, antiquated, disparate technology which drives unnecessary maintenance costs, operates at slow speeds, and embeds too many patches
We Focus on Evidence and Science
- Real time data on compliance/adherence, ratings quality and eligibility criteria improves study data quality, subject selection and outcomes precision
- We have a deep focus on neuro psychiatric conditions
- Our experience of designing and implementing EMA integrated trials to meet bespoke study objectives is unparalleled and key to measure meaningful change and separation
Integration of EMAs, eCOA, eDiaries, and digital data in a single platform
- We are the only singular technology platform purpose built to collect both in the clinic and real world data – we are SSO, web based, device agnostic, and integrate audio/video interview and recording functions
- We can start up our platform in 2-4 weeks and have the flexibility to meet protocol amendments in less than a week
- We fully integrate all functionality throughout the trial (and across trials for registered raters), including flags and alerts, rater training, rater surveillance, central ratings, and outcomes analytics
EMA unlocks powerful insights into relationships between COA and digital data
- Data security compliant with FDA and GDPR guidelines
- Data visualization in near real time to show compliance, enhance subject selection, and measure meaningful change
- Clean data collection for prospective and retrospective data analysis
Proud Member of ACNP
Proud Member of ACNP
Our Differentiation
- Purpose built, web based, fully integrated technology platform which is device/OS agnostic, enables faster start up timelines, has the agility to address protocol amendments in a few days and offers sponsors exponential cost savings relative to legacy technology
- Collect data in the clinic and the real world for complete trial design flexibility
- Contemporaneous data visualization from proprietary, automated flags/alerts drives higher compliance, better outcomes quality and enables smaller, faster trials
EMAs connect COAs and digital measurements. A growing body of evidence from EMA Wellness demonstrates the capabilities to utilize COA, digital and EMA into real-time, multi-modal analyses for high value use cases.
COAs are the ‘gold standard’ for many trials today. COAs are typically retrospective, subjective and administered at weekly or monthly intervals. EMAs compliment and correlate with COAs by ‘filling the gap’ with daily, real-time assessments.
Digital biomarkers and measurements have the potential to objectively measure health outcomes. Challenges with validity, reliability and lack of standardization can limit the impact. EMAs, as active collection of participant data, provide context and correlation to passive collection of digital measures.
Realizing the Value of EMA Wellness in Clinical Trials
EMA Wellness is the industry leader in design and delivery of EMAs. Our scientific leadership is paired with a leadership team with a track record of executing innovation and technology in clinical trials.
Recognizing the Potential of EMAs in Clinical Studies
Ecological Momentary Assessments (EMAs) collect ‘in the moment’ data from patients which provide critical insights into the quality and meaning of both primary endpoint and digital biomarker data.
For over 5 years, EMA Wellness has been designing, implementing and analyzing EMA, COA and digital data in clinical research, ranging from NIH funded studies to international registration programs. Let us show you the evidence, and the impact that EMAs delivered by EMA Wellness can have in your programs.
EMA Wellness
Platform
Design, delivery and interpretability of EMAs differentiate our company. Simple, purpose built technology to collect and integrate data for the requirements of the trials of today differentiate our platform.
Execution: A proven leadership team; a partner in international registration studies
Timelines: Average of 4-6 weeks from requirements to delivery
Full Service eCOA by Industry Experts
Tailored Solutions
Meeting the Needs of Today's Studies
We understand that quality eCOA is more than creating electronic “forms”. EMA Wellness delivers the full spectrum of eCOA, including eDiaries. We supporting services such as scale licensing and translations to maintain control of timelines.
Our eClinRO solution includes integrated Rater Training, restricting access of scales to qualified raters. We support audio/video recording of interviews and offer a compliant clinical review platform for quality control and eligibility reviews.
For patients, BYOD through our app is offered, and the combination of eCOA with EMAs creates unmatched patient engagement, leading to higher compliance.
Digital Biomarkers, Sensors and Wearables
Simplifying
Digital Data Collection
“Fit for purpose” is a term used to describe incorporate digital measurements. Incorporating appropriate digital measurements into a study design is a critical first step, followed by the capabilities to collect and analyze the data efficiently. Our scientific and clinical team can provide insights and guidance ahead of the implementation into the technology.
Limitations on a platform should not determine what digital measures can be collected. Whether study needs are for established digital biomarkers or for exploratory wearable/sensor data, the EMA Wellness platform is designed to securely and seamlessly collect digital measurements. Our approach is to integrate, providing as efficient an experience for participants and sponsors. Talk to us about what your ‘fit for purpose’ needs are, and we’ll fit those into our platform.
Data and System Interoperability
Reduce Friction
Improve Efficiency
The EMA Wellness platform offers seamless workflow and data integration from systems, sensors and digital data sources–offering greater efficiency in meeting the needs of today’s trials. The core principles within our platform are data security and data standardization.
Our approach allows clients to select ‘best in breed’ systems and DHTs that best serve study requirements. The platform is device agnostic, with Web and app based combinations and options.
To date, EMA Wellness supports over 250 APIs in our library.
Analytics and Insights
Understanding
and interpreting key findings
Understanding the objectives and key insights of data are critical. Whether it is accessing our data rich standard reporting, or customized analytics from our scientific and clinical experts, EMA Wellness offers clients clear, interpretable insights.
In study analytics and reporting are standard features of the EMA Wellness solution. Additionally, retrospective analysis of prior studies and leveraging our database of hundreds of thousands of data points provide sponsors with evidence-based decision support.
Whether it is understanding how EMA compliance can predict adherence in your study, or assistance with SAPs for regulatory filings, EMA Wellness is ready to be a partner in interpreting your data.