A clinical study setup has to match more than the protocol. It has to match every IRB-approved document behind it, from the consent form to the wording of each survey question. It also has to match the decisions made during configuration, like when a survey opens, when it expires, and which reminder a participant receives.
Our study configuration agent carries those requirements into the platform. Testing validates that they were configured correctly. A mismatch caught before launch means a fix. One caught after launch may end up as a protocol deviation, with participants getting a different experience than the one the IRB approved.
Study teams test by hand. For each study, the project team works through dozens of test cases, comparing the setup against the approved documents side by side and walking through each participant journey to confirm it matches the intended workflow. When something changes, parts of that work must start over.
At PicnicResearch, a testing agent checks every study configuration element before it goes to the sponsor. It reads the protocol and the source materials, drafts the test cases, and runs them on the draft study with test accounts, moving through the study the way a participant would. The rare test it can’t run on its own goes to the accountable person on our team. It saves screenshots as evidence for each test and, when testing is complete, produces a summary report.
Our agent confirms two things: that the setup works as defined and that it matches what the IRB approved. Together, the tests cover the full spectrum of participant journeys: onboarding and consent, eligibility, surveys and symptom diaries, wearables, compensation, reminders, and withdrawal.
The agent records the finding and logs a defect for our team with what it expected, what actually happened, and the evidence. Our team corrects configuration issues. For code defects, a background agent can take a first pass at the fix, and engineering reviews and approves each one before it goes in. The testing agent then reruns the test to confirm it passes.
Once our team reviews the results and approves the setup, the sponsor runs their own user acceptance testing (UAT). Depending on the study, that means recorded walkthroughs, a live demo of key scenarios, or test accounts they use to go through the study themselves. Each route ends the same way: the sponsor gives explicit approval before the study can launch.
Say a study’s IRB-approved materials tell participants they’ll get a reminder 2 days before each survey closes, but the configuration never schedules it. The testing agent moves through the study as a participant would, reaches the survey, and the reminder never arrives. It logs the defect with what it expected, what actually happened, and the evidence. Our team adds the missing reminder to the configuration, and the agent reruns the test to confirm it goes out on time. The setup doesn’t move forward until it passes.
Sponsors get a study validated against its approved documents before they review it, and a UAT completion report built from the test results. The report documents what was tested, the results in each area, how findings were resolved, and the sponsor’s acceptance. It’s written for the Trial Master File as the record of system validation.
With the agent running the test cases, our study team spends less time clicking through test paths and more time on what needs judgment: reviewing findings, resolving edge cases, and working with the sponsor through UAT.
Testing completes the path that configuration starts: requirements traced to their sources, built into the configuration, and confirmed before launch.
The study the IRB approved is the study your participants get.
Talk with our team about your next study.
patients onboarded to platform
medical visits processed
facilities provided medical records
healthcare providers
research programs
published posters and manuscripts
partnerships with top 30 pharma
Discover how PicnicHealth data powered medical research in 2021
New methods to improve the identification of lupus nephritis patients in RWD using narrative text extraction were presented at the American College of Rheumatology Convergence virtual conference.
Ultragenyx and PicnicHealth presented preliminary data at the International Network for Fatty Acid Oxidation Research and Management (INFORM) LC-FAOD conference, showcasing the power of linking medical records to patient reported outcomes to better understand the complexities in LC-FAOD care.
We joined Roche-Genentech and other key researchers to introduce a longitudinal, patient-centric Hemophilia A real-world dataset that features abstraction of data points from medical records at scale and supplementation with patient-reported outcomes at the American Society of Hematology annual meeting.
Also at ASH 2021, Roche-Genentech and our research partners presented new findings looking specifically at mild and moderate hemophilia A patients found in PicnicHealth’s RWD cohort to better understand disease burden and healthcare resource utilization in this historically underrepresented patient group.
This year, experts from PicnicHealth joined podcasts, webisodes, virtual summits and much more to speak to the importance of patient-centric approaches when building complete, deep real-world datasets.
CMO Dan Drozd joined The Evidence Base to discuss how to build and measure data completeness
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BBC Storyworks and Roche featured Noga Leviner and her medical journey in “The power of partnerships”
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CEO and Co-founder Noga Leviner joined our partners Komodo Health to discuss patient-centric RWD in “For the Health of It”
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PicnicHealth experts joined Arsenal Advisors in 3 summits to highlight our research partnerships
(from 13 patients with LC-FAOD)
38% Female
15 providers / patient
7.5 years of data / patient
(from 13 patients with LC-FAOD)
patients onboarded across 19 conditions
medical visits processed
healthcare providers
Facilities provided medical records
Change Champions onboarded
Research programs
published posters and manuscripts
partnerships with top 30 pharma
At ASH 2022, Genentech, a member of the Roche group, and our research partners presented their study examining the epidemiology and bleeding phenotype in females with mild Hemophilia A (HA), a minority group that is poorly characterized, compared with a cohort of males with mild HA.
At EHA 2022, Novartis used PicnicHealth’s real-world data to characterize sickle cell disease and burden of illness in the United States.
Genentech leveraged the FlywheelMS cohort to describe COVID-19 vaccination patterns and COVID-19 outcomes among people with multiple sclerosis (pwMS) and in subgroups of pwMS, including by disease-modifying therapy (DMT) status.
We partnered with Alexion, AstraZeneca Rare Disease to help identify flares in Lupus Nephritis patients by combining structured and unstructured medical records with lab data.
Cohort Overview. Understand patient healthcare utilization throughout disease history with ability to probe for meaningful mentions and events.
Sickle cell (SC) is the most common inherited blood disorder in the United States. Red blood cells become rigid and shaped like crescent moons, preventing oxygen from getting to parts of the body. This can cause fatigue, severe pain, organ damage or stroke.
Addition of Narrative Text Abstraction to ICD-Based Abstraction Significantly ImprovesIdentification of Lupus Nephritis in Real-World Data
Join our early breast cancer registry to be counted and share your story with research.
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List the names of all the doctors, hospitals, and other facilities your loved one visits regularly, along with those they have visited in the past. Try to go back as far as you can, striving for at least the last 5-10 years, but do your best. Even if you can’t remember them all, having a strong baseline can help you quickly identify gaps in records.
It is important to make sure that you are fully empowered to make decisions on behalf of your loved one with Alzheimer’s. Your relationship status with the patient may not be enough to legally give you access to your loved one's medical information. It is a good idea to talk to an expert about securing special legal status, such as Power of Attorney (POA), a legal document that allows an individual to name someone as their decision maker should they no longer be able to make decisions on their own.
It’s important to have all of your loved one’s medical records together in one spot. This makes it much easier for you and your loved one’s physicians to accurately map the patient’s medical journey and more easily share information between doctors. Fortunately, tools exist to make record management and access simple. A free resource like PicnicHealth helps you collect and organize all of this information. PicnicHealth’s intuitive timeline allows you to pinpoint data across the medical history, eliminating your need for keeping heavy binders filled with paper records or keeping track of multiple software portal logins.
The better you understand your loved one's medical history, the better you can advocate on their behalf. Access and understanding of this information will help you to ask informed questions with physicians. Through regular communication backed by the data in the medical records, you can help your loved one’s care team develop a more successful care plan.
Learn more about PicnicHealth’s commitment to the Alzheimer’s community and the Alzheimer’s Association
Learn MoreWhen you’re juggling appointment times and insurance claims, putting a robust support system together might not strike you as the most urgent task. Investing the time to cultivate relationships with people can turn to in times of need will pay dividends. The next time you need a last-minute ride or just someone to listen, you won’t be on your own.
There are many condition-specific support groups and support groups for caregivers generally in person or online. In addition to the encouragement and empathy they provide, support groups can be a helpful source of tips, resources, and recommendations for navigating caregiving.
The backbone of effective caregiving is organization. Keep medical information, appointment schedules, and medication lists in order. Use a planner or a digital service like PicnicHealth to stay on top of your responsibilities. This attention to detail can prevent future complications and reduce day-to-day stress.
We’ve seen incredible breakthroughs in treatment over the past couple of years, powered by patients and their caregivers participating in research. Stay in the loop about the latest in medical advancements and available resources that could benefit your loved one. Whether it’s a new therapy option or a community service that aids independence, being informed can make a world of difference in the quality of care you provide.
It may seem self-centered to focus on self-care—but when you feel good, you can be a better caregiver. Whether it’s exercise, a mindfulness practice, a soak in the bath, or just time to rest when you need it, carve out those moments in the day when you can unwind, reset, and stay healthy mentally and physically. Think of it as building up your reserves of kindness, patience, and understanding—which can only benefit your loved one. No one can pour from an empty cup.
Easily manage all of your loved one's medical records and contribute to ongoing Alzheimer's research with PicnicHealth.
Learn More(from 13 patients with LC-FAOD)
38% Female
15 providers / patient
7.5 years of data / patient
(from 13 patients with LC-FAOD)
We hope you found this session informative! Sign up for PicnicHealth’s Alzheimer’s research program below.
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