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Electronic Data Capture · Clinical Research
Clinical Trials Run on Clean Data. Ours Ensures Exactly That.
Peerbits builds custom Electronic Data Capture systems for clinical trials, observational studies, and post-market surveillance — engineered for 21 CFR Part 11, GCP, ICH E6(R2), and GDPR compliance from the ground up, not retrofitted after audit failures.
Up to 80% of clinical trial delays trace back to data quality issues. Paper CRFs, disconnected spreadsheets, and generic data tools generate the kinds of queries, errors, and audit findings that push timelines — and budgets — past breaking point.
90%
Reduction in data query rate vs. paper CRF
21 CFR
Part 11 compliant architecture built in
4 wks
From study design to first patient enrolled
Regulatory Standards
21 CFR Part 11
ICH E6(R2) GCP
FDA 21 CFR Part 312
GDPR / HIPAA
CDISC ODM / SDTM
ALCOA+ Principles
ISO 14155
Where Clinical Trial Data Goes Wrong — and How We Fix It
Data quality issues are the most common and costly source of clinical trial failure. Every problem below has a specific, engineered solution in the Peerbits EDC platform.
Where sponsors and CROs struggle
Paper CRFs & Disconnected Spreadsheets
Sites still using paper case report forms introduce transcription errors, illegible entries, and lost data at every step. Spreadsheet-based data collection has no audit trail, no validation logic, and no query management — creating a data cleaning nightmare before lock.
40% of trial delays from paper CRF issues
Data Queries Discovered Late — After Database Lock
When edit checks and validation rules aren't built into the data capture layer, queries pile up at database lock — when fixing them is most expensive, most time-consuming, and most likely to delay regulatory submission.
30% of trial budget lost to late-stage data cleaning
Audit Trail Gaps & 21 CFR Part 11 Failures
Generic data tools — REDCap, Excel, even some commercial EDC platforms — lack the audit trail depth, electronic signature workflows, and access control granularity required by FDA 21 CFR Part 11 and EMA Annex 11 regulations.
$1M+ average cost of a single FDA audit finding
Multi-Site Data Inconsistency
In multi-center trials, each site interprets and enters data differently — varying assessment scales, different unit conventions, inconsistent adverse event grading — making cross-site analysis unreliable and regulatory review unpredictable.
60% of multi-site trials flag inter-site variability
The Peerbits EDC solution
Digital-First CRF with Offline Capability
Purpose-built electronic CRFs with responsive design for tablet and mobile — with offline data capture for sites with unreliable internet, automatic sync when connectivity resumes, and zero data loss guarantee. No paper. No transcription errors.
Offline-first · Auto-sync
Real-Time Validation & Auto-Query Generation
Edit checks fire at the point of data entry — range checks, cross-field validations, date logic, and protocol-specific constraints — automatically generating queries for outliers and missing data before the CRF is even saved. Queries resolve at the source, not after lock.
Point-of-entry validation
21 CFR Part 11-Native Audit Trail
Every data entry, modification, deletion, and approval is captured in an immutable audit trail — timestamped, user-attributed, with reason-for-change documentation. Electronic signatures meet FDA 21 CFR Part 11 and EMA Annex 11 requirements by architecture, not by policy.
Immutable · FDA compliant
Centralized Monitoring & Cross-Site Consistency
Protocol-enforced CRFs, mandatory assessment scale definitions, unit standardization, and AE grading guides built directly into the data entry interface — ensuring every site enters data the same way, regardless of their local practices or experience level.
Protocol-enforced consistency
From Study Design to Regulatory Submission — in One Platform
The Peerbits EDC platform covers every stage of the clinical trial data lifecycle — from protocol setup through CDISC-compliant submission package generation.
STEP 1
Protocol & Study Setup
Drag-and-drop CRF builder, edit check library, visit schedule configuration, and role-based permission setup — study live in 2–4 weeks.
STEP 2
Site Data Entry
Responsive, tablet-optimized eCRFs with offline capability, subject randomization, and patient-reported outcome (ePRO) capture built in.
STEP 3
Real-Time Validation
300+ pre-built edit checks plus custom protocol-specific rules fire at entry — range validation, cross-form checks, AE severity logic, and date arithmetic.
STEP 4
Query Management
Auto-generated queries routed to site coordinators with deadline tracking, sponsor response, source data verification (SDV) workflow, and resolution audit log.
STEP 5
Database Lock & eSign
Electronic database lock workflow with principal investigator e-signature, 21 CFR Part 11-compliant authentication, and freeze/lock state management.
STEP 6
CDISC Export & Submit
Automated SDTM and ADaM dataset generation, ODM-XML export, Define.xml creation, and reviewer's guide — submission package ready for FDA eCTD.
Every Feature Your Study Team Needs — Built In
From phase I first-in-human trials to global phase III multi-center studies — the Peerbits EDC platform is configured for your study, not built for a generic average.
No-code CRF design
Drag-and-Drop CRF Builder
Build eCRFs visually — text fields, dropdowns, checkboxes, date pickers, visual analog scales, and complex branching logic — with no coding required for standard study designs. Protocol deviations generate instant alerts.
CTCAE · RECIST · NCI
Real-Time Edit Checks & Validation
300+ pre-built clinical edit checks plus custom rule builder — range validations, cross-form consistency, lab value plausibility, AE-concomitant medication cross-checks, and RECIST/CTCAE-specific rules.
50+ countries supported
Multi-Site & Multi-Language
Support for global trials across 50+ countries — multi-language CRF display, timezone-aware visit scheduling, site-specific configuration, and per-country regulatory requirement handling within one study instance.
Risk-Based Monitoring
Centralized Monitoring (RBM)
Risk-based monitoring dashboards for clinical monitors — site performance scoring, data completion metrics, query aging reports, protocol deviation tracking, and signal detection for safety monitoring boards.
MedDRA · SAE timelines
Adverse Event & SAE Workflow
Structured AE/SAE reporting with CTCAE grading guidance, causality assessment, regulatory reporting timeline tracking (7-day and 15-day expedited reports), and MedDRA coding built into the data entry flow.
SF-36 · EQ-5D · PROMIS
ePRO & Patient-Reported Outcomes
Patient-facing mobile app for electronic patient-reported outcomes — symptom diaries, PRO questionnaires (SF-36, EQ-5D, PROMIS), medication compliance logs, and wearable device data integration.
RTSM · Stratified Randomization
Randomization & IRT (RTSM)
Interactive Response Technology for subject randomization, stratification by site/strata, drug dispensation management, treatment arm assignment, and blinding management for controlled trials.
ALCOA+ compliant
21 CFR Part 11 Audit Trail
Every field-level change captured with timestamp, user identity, prior value, new value, and reason for change — immutable, non-repudiable, and exportable for regulatory inspection without prior notice preparation.
SDTM · ADaM · ODM
CDISC SDTM / ADaM Export
Automated CDISC-compliant dataset generation — SDTM domain mapping, ADaM dataset derivation, Define.xml, reviewer's guide, and annotated CRF — ready for FDA eCTD submission without manual rework.
EDC Systems for Every Type of Clinical Research Organization
Whether you are a sponsor running your first Phase II trial or a global CRO managing 50 concurrent studies — our EDC platform is configured for your exact research environment and regulatory context.
End-to-end EDC for Phase I through Phase IV clinical trials — from FIH dose-escalation studies with complex safety windows to large Phase III multi-regional trials with CDISC submission requirements.
Solves:CDISC compliance, regulatory submission readiness, multi-region site management
White-label or sponsor-branded EDC deployment for CROs managing multiple concurrent studies — with study isolation, sponsor access controls, and centralized monitoring across all active protocols.
Solves:Multi-sponsor study management, white-label branding, centralized CRO operations
Investigator-initiated trial support with simplified CRF building, IRB documentation management, and affordable pricing structures for academic studies — without enterprise EDC complexity or pricing.
Solves:IIT complexity, IRB data requirements, academic budget constraints
ISO 14155-compliant EDC for medical device clinical investigations — IDE/PMA study data capture, adverse device effect tracking, device performance data, and CE mark submission datasets.
Solves:ISO 14155 compliance, IDE study data, device AE reporting
Pragmatic trial and RWE study platforms — registry data capture, EHR data integration for automated data pull, patient survey tools, and longitudinal cohort management without complex trial infrastructure.
Solves:EHR data integration, registry builds, longitudinal patient tracking
Pharmacovigilance data collection, PSUR/PBRER data management, periodic benefit-risk evaluation, and post-approval safety study (PASS) data capture — integrated with regulatory reporting timelines.
Solves:ICSR collection, PSUR data, EudraVigilance and FAERS submission readiness
Built to Survive Any Regulatory Inspection
Every architecture decision in the Peerbits EDC platform is made with regulatory inspection in mind — not retrofitted after audit findings. Here is what that means in practice.
21 CFR Part 11
FDA electronic records and electronic signature requirements — immutable audit trail, role-based access control, electronic signature binding, system validation documentation, and computer system validation (CSV) support package.
FDA compliant
ICH E6(R2) GCP
International Council for Harmonisation Good Clinical Practice — audit trail completeness, data integrity controls, source data verification support, and inspection-readiness documentation for global regulatory submissions.
GCP compliant
EMA Annex 11 & GDPR
European Medicines Agency computerised systems requirements — data integrity, backup and recovery, business continuity, and EU GDPR-compliant patient data handling with data processing agreements for European trial sites.
EMA & GDPR compliant
CDISC Standards
Clinical Data Interchange Standards Consortium — SDTM domain mapping, ADaM dataset derivation, ODM-XML data exchange, CDASH data collection standards, and Define.xml for regulatory submission packages.
SDTMADaMODM
ISO 14155
Medical device clinical investigation standard — ISO 14155:2020 compliant data capture, adverse device effect structure, device traceability, and clinical investigation report data requirements for CE mark and FDA 510(k)/PMA submissions.
Device trials ready
ALCOA+ Data Integrity
Every data point captured adheres to ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available — as required by FDA, EMA, and PMDA regulators.
ALCOA+ by design
Computer System Validation (CSV)
Full CSV documentation package — IQ, OQ, PQ protocols, validation test scripts, risk assessment, user requirements specification (URS), and system validation summary report — ready for your quality assurance review.
CSV package included
HIPAA & ISO 27001
HIPAA-compliant PHI handling with signed BAAs, ISO 27001-aligned information security management, SOC 2 Type II certified infrastructure, penetration testing, and encrypted data at rest and in transit.
HIPAASOC 2ISO 27001
Real life example of patient engagement software delivered by Peerbits
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Why Research Teams Choose Peerbits EDC
The EDC market is crowded with expensive platforms that charge per-subject fees and take months to configure. Peerbits delivers a custom, fully validated EDC system that fits your study — not the other way around.
Built for your protocol, not a generic average study
Commercial EDC platforms force your protocol into their templates. Peerbits builds the EDC around your protocol — custom CRF structure, edit check library, visit schedule logic, and reporting dashboards designed for your data needs.
Fixed cost — scale enrollment without cost shock
No per-subject, per-site, or per-user fees that compound as your trial grows. Peerbits operates on a fixed project engagement model — your per-subject data cost actually decreases as enrollment increases.
First patient enrolled in 4 weeks, not 6 months
Commercial EDC platform configuration timelines average 4–6 months for complex studies. Our pre-built component library, regulatory-validated base system, and dedicated build team deliver study-ready EDC in 4 weeks.
Validation documentation delivered, not sold separately
Computer System Validation (CSV) documentation — IQ, OQ, PQ protocols, validation summary report — is included in every engagement, not an expensive add-on that doubles your budget after contract signature.
Clinical research domain knowledge, not just software engineers
Our team includes clinical data managers and regulatory affairs consultants who have worked in clinical operations — not just software developers configuring a platform they don't clinically understand.
Your data, your system — zero vendor lock-in
At study close, you own the system, the data, and the source code. No perpetual licensing fees, no data held hostage in a vendor's cloud, and no dependency on a single vendor for your research infrastructure.
vs. Medidata Rave / Oracle CTMS / REDCap
Unlike enterprise EDC platforms that charge $800–$2,000 per subject and take 6+ months to configure, or academic tools like REDCap that lack full 21 CFR Part 11 compliance and CDISC export automation, Peerbits delivers a custom-built, fully validated EDC system with a fixed project cost — compliant, configurable, and yours to own at study close.
What Research Teams Achieve With Peerbits EDC
Measured across clinical trial studies completed using the Peerbits EDC platform.
4 wks
From signed contract to first patient enrolled
vs. 4–6 months commercial EDC avg.
90%
Reduction in data query rate vs. paper CRF
Point-of-entry validation impact
Zero
Regulatory audit findings on Part 11 compliance
Across all completed studies
100%
CDISC SDTM dataset first-pass acceptance rate
With FDA and EMA reviewers
What Principal Investigators & Data Managers Say
#clientspeak
Learn more about our processes from our clients
Play Video
After a rigorous selection process choosing Peerbits as our technology partner was the right choice. Peerbits is an innovative company with a team of talented, committed, and smart individuals. Thank you for helping us deliver world-class healthcare solutions. Good job.
Dan
Health vector
Your Next Trial Deserves Clean Data From Day One.
Start with a free study design consultation — we'll review your protocol, identify your EDC requirements, and show you how the platform handles your specific CRF structure, edit checks, and regulatory submission needs.
Request a Free Study ConsultationFrequently asked questions
An EDC system is a software platform used in clinical trials to collect, manage, and validate patient data electronically — replacing paper case report forms (CRFs). It captures data at the point of entry, applies real-time validation rules, manages data queries, and produces regulatory-compliant datasets for submission to FDA, EMA, and other health authorities.
Yes. The platform is built with 21 CFR Part 11 compliance by architecture — not retrofitted. Every data entry, modification, and deletion is captured in an immutable, timestamped audit trail with user attribution and reason-for-change. Electronic signatures meet FDA Part 11 and EMA Annex 11 requirements, and a full Computer System Validation (CSV) documentation package is included with every engagement.
Most studies go live — first patient enrolled — within 4 weeks of contract signature. Our pre-built component library, regulatory-validated base system, and dedicated build team eliminate the 4–6 month configuration timelines typical of commercial EDC platforms. Complex multi-regional Phase III studies may require additional time depending on CRF complexity and site count.
Yes. The platform generates CDISC-compliant SDTM and ADaM datasets automatically at study close — including SDTM domain mapping, ADaM dataset derivation, ODM-XML export, Define.xml, annotated CRF, and reviewer's guide. SDTM datasets generated by the platform have achieved 100% first-pass acceptance with FDA and EMA reviewers across completed studies.
The platform supports Phase I through Phase IV clinical trials, investigator-initiated trials (IITs), medical device investigations (ISO 14155), real-world evidence and observational studies, post-market surveillance, and pharmacovigilance studies. It is configured for your specific study type — not a generic template.
Yes. The platform includes offline data capture capability — site coordinators can enter CRF data without an active internet connection, and all data syncs automatically when connectivity is restored. Zero data loss is guaranteed during offline sessions.
Peerbits operates on a fixed project engagement model — no per-subject, per-site, or per-user fees. Unlike commercial EDC platforms that charge $800–$2,000 per subject, your cost does not compound as enrollment grows. Computer System Validation (CSV) documentation is included, not sold as an add-on. At study close, you own the system, the data, and the source code.
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