Can you integrate with our EDC or CTMS?

Yes, through the APIs or data import formats your system supports, such as CDISC ODM for clinical data. We map EHR-sourced data to your study's structures and keep a record of every transfer.

How do you protect participant data?

Participant data is handled under HIPAA safeguards where they apply and under your study's consent terms: role-based access, audit logs, encryption in transit and at rest, and only the data the protocol needs.

Scientists working in a research lab, with a clinical trial pre-screening status and a 21 CFR Part 11 controls checklist

Healthcare / Life Sciences

Life sciences and clinical trial software development

Clinical trials lose time to slow recruitment, paper consent and data re-entered between systems. Agnotic Technologies builds software for pharma, biotech and clinical research teams: trial matching, eConsent, data capture and participant engagement, with audit trail and electronic signature controls designed in.

15-Minute Scoping Call

21 CFR Part 11

Audit trails and electronic signatures

FHIR · CDISC

From EHR data to study data standards

eConsent

Remote consent with version control

Trusted by global innovators

Industry Overview

What is life sciences software development?

Life sciences software development is building the systems pharma, biotech and research teams use to run studies and work with participants: recruitment and eligibility screening, electronic consent, data capture and engagement apps. Agnotic Technologies builds this software with the audit trail and electronic signature controls that 21 CFR Part 11 expects.

Who it is for

Who do we build for in life sciences?

Different organizations own different parts of a study. These are the teams we work with.

Contract research organizations

CROs running studies on behalf of sponsors.

Tools that work across sponsors and sites
Site workload and coordinator time
Consistent audit trails across studies

Research sites and academic medical centers

Sites that screen, consent and follow participants.

Manual chart review for eligibility
Paper consent and version tracking
Data re-entered from the EHR

Digital health and therapeutics companies

Companies running studies to prove their product works.

Decentralized and remote study designs
App data used as study data
Evidence for buyers and regulators

Industry Challenges

Why do clinical trials fall behind schedule?

Delays build up from a few manual steps that software can take over.

Recruitment by chart review: coordinators read records one by one to find eligible patients.
Paper consent: forms are hard to version, track and explain to participants at home.
Data entered twice: values already in the EHR are typed again into study systems.
Participants drop out: long gaps between visits and little contact in between.

Our Approach

How does software speed up trial recruitment?

Matching software screens patient records against eligibility criteria so coordinators review likely candidates instead of every chart. People make every enrollment decision.

Criteria as rules

Inclusion and exclusion criteria turned into structured, testable rules.

EHR data through FHIR

Diagnoses, labs and medications read from the EHR rather than retyped.

Coordinator review queue

Likely matches ranked for review, with the reason each patient was flagged.

Capabilities

What do we build for clinical research?

Software for each stage of a participant's journey through a study.

Trial matching and pre-screening

Eligibility screening from EHR data with coordinator review.

eConsent

Remote consent with multimedia explanations, version control and signatures.

Participant apps

Visit reminders, questionnaires and electronic patient-reported outcomes.

Site and coordinator dashboards

Screening, enrollment and visit status across a study.

EHR to study data transfer

Mapped data transfer from site EHRs to sponsor systems, with a record of every transfer.

Remote visit support

Telehealth visits and home device data for decentralized designs.

Engineering Stack

Which standards and technologies do life sciences projects use?

The standards and platforms we work with on clinical research software.

Standards

FHIR R4CDISC ODMCDISC SDTMHL7 v2

Study systems

EDCCTMSeTMFeCOA

Apps

React NativeNext.js

Backend

PythonNode.jsPostgreSQL

Infra

AWSAzure

Part 11 controls

Which 21 CFR Part 11 controls do we build in?

Part 11 sets requirements for electronic records and signatures in FDA-regulated activities. These are the controls we design into study software.

21 CFR Part 11 requirements and how we build each control
Requirement	What it covers	How we build it
Audit trails (11.10(e))	Secure, time-stamped records of who created, changed or deleted a record	Append-only audit logs that keep previous values and cannot be edited by users
Access control (11.10(d))	Limiting system access to authorized people	Role-based access with individual accounts and session controls
Record copies (11.10(b))	Accurate, complete copies for inspection	Human-readable and electronic exports of records with their audit history
Signature manifestation (11.50)	Signer name, date and time, and meaning of the signature	Signatures displayed with all three elements on the signed record
Signature linking (11.70)	Signatures that cannot be removed or copied to other records	Signatures cryptographically bound to the record they sign
Validation (11.10(a))	Evidence the system works as intended	Specifications, traceability and test evidence for your validation package

Measured Impact

What should a trial technology program measure?

Measures we build reporting around, tracked against your own study plan.

Screening

Screened to enrolled

Participants enrolled, divided by participants pre-screened.

Speed

Time to first participant

Time from site activation to the first enrolled participant.

Consent

Consent completion

Consent processes completed, divided by consent processes started.

Queries

Data query rate

Data queries raised per participant visit.

My Lauren Maternal Health Platform | Built by Agnotic

A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.

Case Study

Read the case study

My Lauren Maternal Health Platform | Built by Agnotic

LERA Health: Compliant Women’s Health App Platform

A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.

Case Study

Read the case study

Use Cases

Where does this software fit in a clinical study?

Points in a study where software takes over manual work.

Feasibility

Estimating eligible populations at candidate sites from EHR data.

Pre-screening

Finding likely eligible patients for coordinator review.

Consent

Remote eConsent with version control and signatures.

Visits and outcomes

Reminders and electronic patient-reported outcomes between visits.

Data transfer

Moving site data to sponsor systems without re-entry.

Retention

Keeping participants informed and engaged until the last visit.

Integrations

Which systems do we integrate for clinical research?

Connections between sites, sponsors and participants.

Sites

Site EHRs (FHIR)

Remote visits

Telehealth platforms

Participants

Wearables and home devices

Consent

Identity verification

Compliance-First Development Services Backed by Global Standards

We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.

Health Insurance Portability and Accountability Act

Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.

Fast Healthcare Interoperability Resources

Enabling standardized health data exchange through standards-based API mappings.

Our Edge

Why Global Leaders Choose Us

We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.

Enterprise-Grade Security

We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.

High-Performance Scaling

Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.

Accelerated Time-to-Market

Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.

Embedded AI Integration

Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.

Engagement Model

How does an engagement with a life sciences team work?

We work to your quality and validation procedures. Timing depends on scope, and we agree it on the scoping call.

Scoping call

We agree the study stage, the users and the systems involved.

Requirements and controls

Requirements written with the Part 11 controls and data flows they need.

Build with traceability

Requirements, code and tests linked for your validation package.

Validation support

Specifications and test evidence delivered to your validation team.

Release and support

Controlled releases and support through the study under agreed terms.

Facts and sources

Which rules shape life sciences software?

Short facts on the regulations behind clinical research software, each linked to its official source.

21 CFR Part 11 sets FDA requirements for electronic records and electronic signatures, including audit trails, access controls and signature manifestations.
Source: 21 CFR Part 11 (eCFR)
FDAAA 801 and its final rule require registration and results reporting for applicable clinical trials on ClinicalTrials.gov.
Source: ClinicalTrials.gov
The HIPAA Privacy Rule lets covered entities use or disclose health information for research with a waiver of authorization approved by an IRB or privacy board.
Source: 45 CFR 164.512(i) (eCFR)
The HIPAA Security Rule requires administrative, physical and technical safeguards for electronic protected health information.
Source: 45 CFR Part 164 Subpart C (eCFR)

Voice of success

We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.

“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”

Aaron Phelan

Founder, Benchmark

“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”

John Pasmore

Founder, Latimer

“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”

Kim Smith

Founder, My Lauren

Related services

Where can life sciences teams start with us?

Detailed pages for the services clinical research teams ask us about.

Clinical trial matching

AI that pre-screens patients against eligibility criteria for coordinator review.

Clinical trial management software

CTMS development for sponsors, CROs and sites.

Remote patient monitoring software development

Device data, care team workflows and billing support for RPM programs.

Telemedicine platform development

Virtual visit platforms with scheduling, video and EHR integration.

EHR software development

Custom EHR modules and platforms built around clinical workflows.

HIPAA requirements for software teams

The safeguards we build into every healthcare product.

The Same Engineering Patterns, Across Other Industries

The technical patterns behind this platform translate naturally into adjacent verticals.

AI

Apply private LLM and RAG architectures to clinical knowledge bases.

Education

Extend secure platform engineering to medical education and CME workflows.

Gov & Research

Power national health datasets and population health initiatives.

Frequently Asked Questions

Validation is owned by the regulated company, usually its quality or computer system validation team. We build the Part 11 controls (audit trails, electronic signatures, access control and record copies) and provide the specifications, traceability and test evidence your validation package needs.

Industries