Clinical Trial Software for Brands and Ingredient Manufacturers

About the author

Mackenzie De Jesus, DHSc, MS, Head of Clinical Research. Mackenzie De Jesus, DHSc, MS, leads clinical research at Reputable Health, where she designs and runs decentralized studies that pair wearable data with validated participant-reported outcomes. She holds a Doctorate of Health Science from A.T. Still University and a master’s degree in experimental psychology from Nova Southeastern University. Her background spans health science, experimental psychology, and clinical research, including experience designing and executing clinical trials in functional medicine and digital health.

Clinical trial software is the set of systems that plan a study, capture its data, and keep a record of everything that happened, from enrollment to the last questionnaire. Most guides to it are written for drug sponsors comparing licenses.

A brand or ingredient manufacturer running a supplement or device study faces a different question. You may never license these systems yourself, yet your evidence rests on the record they leave behind.

Here is which systems a wellness study needs, and what to require from whoever runs them.

The short answer

Several systems, one record. A typical study combines operations, data capture, questionnaire, consent, and device data tools.
Wearables add a hidden step. Device readings pass through the device company’s app and cloud before they reach the study.
Part 11 depends on your study. The Food and Drug Administration’s electronic records rule covers records tied to its requirements or submissions.
Regulators can ask for raw data. For research without rigorous peer review, the Federal Trade Commission often requests the underlying documents.
Secure the handover. Agree before enrollment that you receive the full dataset and its change history at the end.

Plan the data before the study

Bring the product or ingredient, the claim you want to evaluate, and how your team will use the results. We’ll walk through the design and show you exactly what you’d receive at the end.

Plan your study

What clinical trial software includes

No single product runs a study. The category is a stack of systems, each holding one part of the record, and the parts a supplement or device study needs differ from what a multisite drug trial needs.

System	What it holds	Typical role in a supplement or device study
Clinical trial management system (CTMS)	What it holdsMilestones, enrollment counts, schedules, budgets, and task tracking	Typical role in a supplement or device studyUsed by whoever runs the study; rarely worth licensing for a single study
Electronic data capture (EDC)	What it holdsStudy data entered against electronic case report forms (eCRFs), with queries and corrections	Typical role in a supplement or device studyCore: the main home of the study data
Clinical data management system (CDMS)	What it holdsData cleaning, coding, query workflows and database lock, often built around the EDC	Typical role in a supplement or device studyCore, usually bundled with the EDC
Electronic clinical outcome assessment (eCOA) and electronic patient-reported outcomes (ePRO)	What it holdsQuestionnaires and diaries participants complete on a phone or computer, each with a timestamp	Typical role in a supplement or device studyCore: validated surveys such as the Pittsburgh Sleep Quality Index (PSQI) are collected here
Electronic consent (eConsent)	What it holdsWhich consent form version each participant signed, and when	Typical role in a supplement or device studyCore for remote enrollment
Wearable data aggregation	What it holdsReadings pulled from consumer devices and matched to participants	Typical role in a supplement or device studyCore whenever a device measures an outcome
Interactive response technology (IRT), also called randomization and trial supply management (RTSM)	What it holdsGroup assignment, blinding and product allocation	Typical role in a supplement or device studyNeeded for randomized, placebo-controlled designs
Electronic trial master file (eTMF)	What it holdsProtocol versions, ethics approvals, contracts and training records	Typical role in a supplement or device studyNeeded in some form; the scale follows the study
Safety database	What it holdsSafety events, their follow-up and any escalation	Typical role in a supplement or device studyNeeded in some form; smaller studies may keep a controlled safety event log
Lab data transfer	What it holdsResults from laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), matched to participants and timepoints	Typical role in a supplement or device studyNeeded when biomarkers are endpoints
Statistical analysis software	What it holdsAnalysis of the locked dataset against the statistical analysis plan	Typical role in a supplement or device studyCore, used after database lock
Participant app and payments	What it holdsReminders, daily check-ins and compensation	Typical role in a supplement or device studyCommon in decentralized studies

Two of these systems have their own explainers on our blog: what a CTMS does in a trial and how electronic data capture works. The rest of this guide covers what changes when the study runs remotely, and the sponsor is a brand or ingredient manufacturer.

For a wellness sponsor, the system that most often decides whether the dataset holds up is the one that brings in device data. Reputable’s protocols use raw measures, such as nightly heart rate variability (HRV) and resting heart rate read against each participant’s own baseline, rather than composite device scores.

Map the wearable data path before enrollment

A reading from a ring or a watch travels further than a questionnaire answer before it reaches the study. Each step is a place where values can be transformed, delayed, or lost, so map the path in the protocol:

Device. The sensor records a signal, and the device company’s algorithm turns it into values such as sleep stages, resting heart rate, or HRV.
Device company’s app and cloud. The participant’s phone syncs the device to the company’s app (Oura or WHOOP, for example), which stores the readings, often alongside composite scores such as readiness or recovery.
Aggregation. The research team’s system pulls the values through an authorized connection and attaches a participant ID and a timestamp to each one.
Study repository. The values arrive in the database the study treats as its source.

The Food and Drug Administration’s (FDA) December 2023 guidance on digital health technologies (DHTs) treats that first durable repository as the location of the source data, and asks sponsors to plan ahead for app updates, security fixes, and devices that go out of stock mid-study. The guidance was written for medical product trials. Its checklist still fits any study that relies on a device, because the same updates reach a supplement study’s participants.

Two choices matter most for a wellness study that uses continuous wearable data. Composite scores such as readiness blend several signals by a formula the device maker controls, so raw measures make the safer endpoint. Device choice also follows the endpoint: a sleep endpoint calls for a device participants will wear through the night.

For the measurement side of this decision, our guide to wearables in decentralized trials covers which signals the common devices capture.

A single value in the final dataset depends on several systems agreeing with each other. Take one participant’s sleep latency on night 14 of a placebo-controlled sleep study:

Consent. The eConsent record shows which form version the participant signed before any data were collected.
Assignment. The randomization system holds the participant’s group, visible only to the people the blinding plan allows.
Product use. The participant app logs the evening dose check-in, which the analysis may need to judge adherence.
Measurement. The device reading arrives through the aggregation step carrying its participant ID and the date and time it was transferred.
Self-report. The same morning’s sleep diary in the eCOA system adds the participant’s own account of the night.
Analysis. The locked dataset joins all five records, and the statistical analysis plan decides how that night counts.

Each handoff between systems is an interface, and each interface is a place where a value can be dropped or mismatched. Ask whoever runs the study how the systems are joined, and whether those joins were tested before the first participant enrolled.

Check whether Part 11 applies to your study

21 CFR Part 11 is the FDA regulation that sets the conditions under which FDA accepts electronic records and signatures as trustworthy. Many software vendors describe their products against it. Whether it governs your study is a separate question.

Question	What the source says	What it means for you
Which records does Part 11 cover?	What the source saysElectronic records kept under FDA’s record requirements, plus electronic records submitted to FDA	What it means for youStructure/function supplement studies generally do not need an investigational new drug application (IND), so ask counsel whether your records fall in scope
Does FDA’s newer guidance reach beyond drugs?	What the source saysFDA’s October 2024 questions-and-answers guidance on electronic systems names clinical investigations of foods among those it covers	What it means for youRead it if an FDA submission is anywhere in your plans
Does FDA certify trial software?	What the source saysThe same guidance says FDA neither certifies electronic signature systems nor reviews electronic systems in advance; systems are examined during inspections	What it means for youA “Part 11 compliant” label is the vendor’s own statement, so ask for the validation evidence behind it
Will anyone outside FDA ask for the data?	What the source saysThe Federal Trade Commission’s (FTC) Health Products Compliance Guidance says that for research without rigorous peer review, the FTC will often ask the marketer for underlying documents and raw data	What it means for youPlan for the record to be produced long after the study ends, whichever FDA rules apply

FDA primarily oversees labeling and the FTC primarily oversees advertising; both expect claims to be truthful, adequately substantiated, and not misleading. Whether a particular study’s records fall under Part 11 is a legal question, so put it to qualified regulatory counsel before you choose systems.

See what a full study delivers

A full clinical study at Reputable runs from protocol and analysis plan to the final report and participant-level dataset. Here’s how that work is scoped.

Explore Clinical Research

Decide whether to license software or rely on a partner

On a first study, the software decision is usually a decision about who operates the systems. The answer depends on the team you already have.

License your own systems when you run studies continually, you employ data management, validation and quality staff, and you want direct control of every configuration and vendor contract.

Rely on a research partner’s systems when you are one of the brands and ingredient manufacturers without in-house research staff, the study is a one-off or an annual project, and you need a defensible dataset more than software skills. That partner is often a contract research organization (CRO).

Choose neither yet when the research question is still open. Settle the question and the design first; the systems follow from both, and a stack chosen before the design tends to shape the study around the software.

Your best setup depends on your study. Reputable runs decentralized studies, and the table below is honest about when another option serves you better.

Setup	What it contributes	Fits a brand or ingredient manufacturer when	Watch for
Your own licensed systems	What it contributesFull control of configuration, data and vendor relationships	Fits a brand or ingredient manufacturer whenYou run several studies a year with research operations staff in-house	Watch forYour team owns validation, access control and vendor oversight
Self-serve research software, run by your team	What it contributesStudy build tools, device connections and participant management	Fits a brand or ingredient manufacturer whenYour staff already design, run and analyze studies	Watch forDesign, safety oversight and analysis stay with your staff
A site-based contract research organization (CRO)	What it contributesEstablished enterprise systems and in-clinic measurement	Fits a brand or ingredient manufacturer whenThe outcome needs a clinic procedure, or an FDA submission is planned	Watch forClinic visits shape the timeline and who can take part
A full-service decentralized CRO	What it contributesStudy systems, the wearable data path, participant support and analysis run by one team	Fits a brand or ingredient manufacturer whenYou lack in-house research staff, and the outcome can be measured remotely	Watch forAgree the data handover terms in writing before enrollment

Decentralized studies remove the need for clinic visits, which often makes them quicker to enroll and less costly to run. A remote design still has to fit the outcome, and some measures belong in a clinic.

Ask six questions about any study’s systems

Whichever setup you choose, these questions show whether the record will hold up. A good partner answers them in writing.

1. Will you receive the full dataset and its change history?

FDA’s 2024 guidance asks sponsors to keep the metadata linked to each data point when a hosted system is retired or a contract ends, and notes that FDA may ask for audit trails when it reconstructs a study. Ask for the participant-level dataset, a guide explaining each variable, and the change history, in formats you can open without the vendor’s software.

2. Who can change a value, and what does the log record?

Part 11 expects computer-generated, time-stamped audit trails in which a correction never hides the original entry. FDA’s guidance adds that the log should say why a value changed. A good answer names the roles allowed to edit and shows a sample entry with who, when, what, and why.

3. How was the system validated for this protocol?

The International Council for Harmonisation (ICH) guideline for good clinical practice, ICH E6(R3), asks in section 4.3.4 for validation of both standard functions and protocol-specific configurations, including automated checks, calculations, and the interfaces between systems. The guideline was written for trials of investigational products, and its systems section is still a sound benchmark for a wellness study. Ask what was tested for your study’s build, such as eCRF edit checks or the device data feed.

4. Who can see what, and how is access removed?

Section 4.3.8 of the same guideline ties access permissions to each user’s duties and blinding arrangements, and expects access to be revoked when someone leaves the study. In a placebo-controlled study, ask who can see group assignments and how that list is reviewed.

5. What happens when a system fails?

ICH E6(R3) expects backups, disaster recovery, and contingency plans that keep data essential to safety and outcomes from being lost. Ask how often backups run, when recovery was last tested, and how a device sync outage is handled.

6. Who helps participants when the app or device stops working?

Remote participants cannot hand a device to a coordinator down the hall. Ask who answers participant support requests, how issues are logged and reviewed, and how missing data is flagged so the analysis plan can account for it.

What software cannot fix in a study

An audit trail shows who changed the data after collection, when, and why. The trail says nothing about whether the endpoint was the right one, the sample was large enough, or the analysis was chosen before the results came in.

The FTC’s guidance treats analyses that depart from the original protocol with suspicion, because searching smaller groups after a flat main result tends to find chance differences. Fix the primary endpoint, the reasoning behind the sample size and the analysis plan before the first participant enrolls, and agree with your team how the findings will inform the next decision.

Software keeps the record honest. The design decides what the record can support.

Where Reputable fits

Reputable Health is a full-service decentralized CRO for health and wellness brands and ingredient manufacturers. The guidance above applies to whichever partner you choose.

Model. Remote participation and data collection, with study design, timelines, and costs tailored to the research question.
Offerings. Two offerings: a pilot study and a full clinical study, and the scope follows your question.
Measurement. Consumer wearables (Oura, WHOOP, Apple Watch, Garmin, Fitbit), validated surveys, and at-home lab kits processed through CLIA-certified partner laboratories.
Participants. Reputable reports 10,000+ participants in its research community, supported by the Heartbeats rewards program and the Reputable Health app.
Operations. Reputable tracks adherence throughout the study, and the study report includes safety and adverse event reporting. Reputable reports an 87% compliance rate across its most recent completed clinical studies.
What you receive. A complete study report and a participant-level dataset with a data dictionary, subject to the protocol, consent, and agreed data-access scope.
Scope. Every study is scoped to your product or ingredient, your claims, and your budget.

Frequently Asked Questions

Short answers to what sponsors ask most often about study software.

What is the difference between a CTMS and an EDC system?

A CTMS tracks how the study is running, such as enrollment, schedules, and budgets. An EDC system holds the study data itself, entered against eCRFs with a record of every correction. Most studies use both, though a sponsor running one study usually sees only the outputs.

Is a survey tool or a spreadsheet enough for a pilot study?

A general survey tool can collect answers, but it rarely keeps a change history, controls who can edit, or matches entries to device data. Whether a pilot can support a claim depends on its design and findings, and a weak record limits what even a well-designed pilot can show. Use systems with audit trails from the first participant onward.

Can participants use their own wearables in a study?

Often, yes. FDA’s guidance on digital health technologies notes that letting participants use devices they already own can reduce their burden, and recommends offering a study-provided device so people without one are not excluded. The protocol should name the accepted devices and the values the study will use from each, and set a baseline period before the product starts, so each participant’s results are read against their own normal.

Who should own the study data when the study ends?

Settle it in the contract before enrollment. FDA’s 2024 guidance recommends written agreements that set out each party’s role in providing electronic systems, and the same principle protects brands and ingredient manufacturers running their own studies. Confirm in writing what you receive, in which formats, and for how long the partner keeps a copy.

The bottom line

A supplement or device study does not need its sponsor to become a software buyer. What it needs is a record that answers questions later, from your counsel, a journal, or the FTC, without anyone rebuilding it from memory.

Before you sign with any research partner, send the six questions above and ask to see an example of the dataset and variable guide they deliver at the end of a study.

Get the six answers for your study

Tell us what you hope to claim and what evidence you hold today. We’ll answer the six questions for your study and talk through a design that could close the gaps.