For Pharma · Biotech · MedTech · CROs · Life Sciences
Peerbits delivers purpose-built technology for life sciences organizations — accelerating clinical trial enrollment, powering real-world evidence programs, automating pharmacovigilance, and connecting patient support programs to the clinical data they need.
Compliance & Standards
THE LIFE SCIENCES BURDEN
Drug development timelines average 10–15 years and $2.6 billion per approved molecule. The organizations compressing that timeline are doing it with data — specifically, with the ability to find the right patients faster, detect safety signals earlier, keep patients on therapy longer, and generate the real-world evidence payers and regulators now demand at submission.
86% of clinical trials miss their enrollment deadlines, and every month of delay costs sponsors an estimated $600K–$8M in lost commercial time. Traditional site-based recruitment relies on investigator relationships and paper referral networks that cannot scale to the patient volumes modern trials require — especially for rare diseases and diverse patient populations mandated by FDA guidance.
Post-approval commitments, label expansion applications, and payer coverage decisions increasingly require Real-World Evidence — longitudinal treatment outcomes from actual clinical practice rather than controlled trial conditions. But this data sits locked inside EHR systems that pharma organizations have no direct access to, requiring expensive and slow manual chart abstraction or registry partnerships that take years to build.
Post-market safety surveillance depends on timely adverse event detection, ICSR triage, MedDRA coding, and regulatory submission to FDA and EMA under strict deadlines — 15-day expedited reporting for serious unexpected reactions. Most pharma organizations still manage this through manual case intake, spreadsheet tracking, and email-based medical reviewer workflows that create unacceptable detection latency and submission risk.
Specialty drug manufacturers invest $500M+ annually in patient support programs — copay assistance, nursing hotlines, adherence coaching, and prior authorization support. But most PSPs operate disconnected from the clinical systems that would tell them a patient abandoned their first fill, missed a lab test required for therapy continuation, or had a prior authorization denied that a support team could have appealed.
FULL SOLUTION SUITE
Nine integrated modules covering clinical development, post-market surveillance, medical affairs, and patient support — all built on a FHIR-native, 21 CFR Part 11-compliant, GxP-validated data infrastructure.
AI-powered patient identification and pre-screening using FHIR-sourced EHR data from participating site networks. Automatically maps eligibility criteria against structured and unstructured patient records — identifying qualified candidates months faster than traditional site coordinator workflows.
Access to 4.2M+ de-identified, FHIR-standardized longitudinal patient records spanning diagnoses, treatments, lab values, prescriptions, and outcomes — structured for outcomes research, label expansion, comparative effectiveness, and payer value dossier support. HIPAA-compliant and RWE-ready.
Automated adverse event signal detection across structured and unstructured data sources — EHR notes, patient registries, social media monitoring, and literature surveillance. AI-assisted ICSR triage, MedDRA auto-coding, causality assessment support, and E2B(R3) regulatory submission to FDA MedWatch and EMA EudraVigilance.
PSP technology platform integrating specialty pharmacy dispensing data, EHR therapy monitoring, prior authorization tracking, and patient-facing engagement — triggering real-time interventions for adherence barriers, fill abandonment, benefit verification failures, and care coordination gaps. Supports hub services, copay assistance, and nurse educator workflows.
Field Medical team enablement with HCP engagement tracking, medical inquiry management, scientific exchange documentation, and congress attendance planning — all within an MLR-compliant, audit-logged environment. Integrates with CRM platforms and generates compliant off-label communication logs for regulatory inspection readiness.
21 CFR Part 11-validated electronic records and signatures, eCTD submission preparation support, regulatory intelligence monitoring across FDA and EMA guidance updates, and CDISC CDASH/SDTM data transformation — reducing submission preparation time and audit finding risk for IND, NDA, BLA, and MAA packages.
Health Economics and Outcomes Research analytics powered by RWE data — cost effectiveness modeling, budget impact analysis, indirect treatment comparisons, and quality adjusted life year (QALY) endpoint analysis for payer formulary submissions and HTA dossiers in US, EU, and APAC markets.
End-to-end technology support for hybrid and fully decentralized trials — remote patient consent (eConsent), wearable and RPM device data integration, telemedicine visit coordination, ePRO collection, and direct-to-patient drug logistics tracking — all within a GCP-compliant, 21 CFR Part 11-validated audit environment.
Real-time formulary status monitoring across commercial, Medicare Part D, and Medicaid plans; automated PA criteria tracking by payer and indication; step therapy exception management; and payer contracting analytics — giving Market Access teams visibility into coverage dynamics and the tools to act on coverage barriers at the point of prescribing.
ENGAGEMENT MODEL
Life sciences implementations require GxP validation, audit trail documentation, and regulatory readiness that generic software vendors cannot provide. Peerbits' engagement is built around the inspection-readiness expectations of FDA and EMA from day one.
STEP 1
Two-week structured discovery with your Clinical Operations, Regulatory Affairs, and Medical Affairs leads — mapping trial protocols, pharmacovigilance workflows, PSP architecture, and regulatory submission requirements to define the exact data infrastructure and validation scope needed.
STEP 2
21 CFR Part 11-validated deployment with GxP qualification documentation — IQ, OQ, PQ — generated for regulatory inspection. CDISC data mappings configured for your study designs. Audit trail and e-signature frameworks activated before any patient data touches the system.
STEP 3
Live deployment on a single trial, indication, or PSP program — with FHIR data feed connections to participating site EHR systems, pharmacovigilance signal monitoring activated, and RWE cohort queries validated against your research protocols and IRB approval parameters.
STEP 4
Enterprise-wide deployment across your clinical, medical affairs, and market access functions — with dedicated Life Sciences Success Manager, validated change control procedures for system updates, and quarterly regulatory readiness reviews benchmarked against current FDA and EMA guidance.
COMPETITIVE DIFFERENTIATION
Compared to siloed offerings from Veeva Systems, Oracle Clinical, IQVIA, and Medidata — Peerbits delivers a unified life sciences platform with FHIR-native RWE access, AI pharmacovigilance, and PSP technology no clinical data vendor currently offers end-to-end.
| Capability | Peerbits | Veeva | Oracle Clinical | IQVIA | Medidata |
|---|---|---|---|---|---|
| Unified Clinical + PV + RWE + PSP Platform | Full Suite | CRM + Vault | EDC + Safety | RWE + Analytics | EDC + DCT |
| FHIR R4/R5 EHR-Sourced RWE Data | 4.2M records | No | No | Claims-based | No |
| AI Pharmacovigilance (Auto-ICSR Filing) | 96% auto | Vault Safety | Argus Safety | Manual triage | No |
| 21 CFR Part 11 Validated Infrastructure | Day 1 | Yes | Yes | Partial | Yes |
| Decentralized Trial (DCT) Infrastructure | Full | Limited | Add-on | Partial | Yes |
| Connected PSP Technology (EHR + Specialty Rx) | Full | CRM only | No | Partial | No |
| HEOR / HTA Dossier Analytics | Included | No | No | Yes | No |
| Average Go-Live Timeline | 90 Days | 6–12 Months | 9–15 Months | 6–9 Months | 4–8 Months |
MEASURED OUTCOMES
Across 85+ life sciences client engagements — from early-stage biotech to top-20 global pharma — Peerbits consistently delivers measurable improvements in trial speed, safety compliance, patient retention, and market access success.
42%
Average reduction in time-to-full-enrollment vs. traditional site-based recruitment — across Phase I, II, and III studies.
4.2M
FHIR-standardized, de-identified longitudinal records available for outcomes research, comparative effectiveness, and payer value dossiers.
96%
Adverse event cases auto-coded and submitted to FDA/EMA without manual intervention — zero missed regulatory deadlines across client base.
29%
Average improvement in 12-month therapy continuation rates for specialty drug PSPs integrating EHR and specialty pharmacy data feeds.
$1.8B
Cumulative value of evidence programs supported — label expansions, payer submissions, post-market commitments, and HTA dossiers across 85+ clients.
100%
Zero missed 15-day expedited ICSR reporting deadlines and zero 21 CFR Part 11 audit findings across all client deployments to date.
6x
FHIR-native cohort queries return study-ready patient populations in days vs. the months required for manual chart abstraction or traditional registry builds.
90
Including IQ/OQ/PQ documentation — compared to 9–15 months for Veeva, Oracle, and IQVIA enterprise implementations of equivalent scope.
From rare disease biotech to global specialty pharma — Peerbits clients share results from their first 12 months of deployment across clinical, safety, and patient support programs.
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Learn more about our processes from our clients
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.
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In a 45-minute session, our life sciences team will assess your current clinical data infrastructure, trial enrollment performance, pharmacovigilance workflows, and PSP architecture — and show you exactly where Peerbits accelerates your pipeline.
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We serve biotech, specialty pharma, global pharma, medical device manufacturers, and CROs — from early-stage clinical programs through post-market surveillance and market access. Our platform is configured for your therapeutic area, trial design, regulatory jurisdiction, and existing clinical data systems.
Either approach works. Many organizations begin with a single high-impact capability — Clinical Trial Patient Matching, RWE Data Platform, AI Pharmacovigilance, or Connected Patient Support Programs — and expand over time. All modules share a FHIR-native, 21 CFR Part 11-validated data layer, so adding capabilities later does not require duplicate interfaces or manual data reconciliation.
We connect to EDC platforms, safety databases, CTMS systems, and site EHR networks via HL7 V2, FHIR R4/R5, CDISC CDASH/SDTM, and E2B(R3) standards. Trial enrollment, PV case processing, RWE cohort queries, and PSP interventions flow through standardized APIs — aligned with FDA, EMA, and ICH GCP requirements.
Most organizations are validation-ready in approximately 90 days, including scientific and regulatory discovery, GxP system configuration with IQ/OQ/PQ documentation, a pilot study on a defined trial or PSP program, and full portfolio rollout. Timelines depend on module scope, therapeutic area, and integration complexity, but our engagement model is designed for minimal disruption to active clinical operations.
Point solutions address one workflow — CRM, EDC, RWE analytics, or DCT — in isolation. Peerbits delivers a unified life sciences platform where clinical trial matching, pharmacovigilance, RWE access, and connected PSP technology share the same FHIR-native data layer — reducing vendor sprawl and manual handoffs between clinical, safety, and market access teams.
Every deployment is architected for 21 CFR Part 11 from day one: validated electronic records and signatures, comprehensive audit logging, GxP qualification documentation, and SOC 2 Type II controls. We align implementations with FDA, EMA, and ICH requirements. Clinical and safety data stays within your boundary — we do not use your data to train shared models without explicit agreement.
Outcomes vary by module and baseline, but clients commonly report 42% faster trial enrollment, 96% ICSR auto-filing rates, 29% specialty drug adherence improvement, and RWE cohort assembly in days rather than months within the first 180 days. We benchmark enrollment timelines, PV cycle times, and evidence program readiness during discovery and track them through quarterly reviews after launch.
Every engagement includes a dedicated Life Sciences Success Manager, ongoing regulatory and compliance updates, SLA-backed support, and quarterly performance reviews. We also refine AI models and validation documentation as your trial protocols, medical policies, and FDA/EMA requirements evolve — so accuracy and compliance improve over time.
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