Bridging Technology
and Real-World Success
Clinical Trial Support
From Patient Charts to Clinical Impact – Precision Mapping, Reliable Management, and Scalable Support
Protocol-Based Patient File Mapping
Our clinical experts review patient records against trial protocols with unmatched accuracy—ensuring every candidate meets eligibility, reducing screen failures, and accelerating time to enrolment.
- Manual and tech-enabled patient chart reviews
- Real-time mapping to protocol-defined inclusion/exclusion criteria
- Expertise across EMR/EHR platforms and data abstraction
- Seamless integration with your site or sponsor workflows
End-to-End Clinical Trial Operations Support
From initiation to closeout, we support every operational touchpoint letting your teams focus on strategy while we ensure consistency, compliance, and delivery.
- Clinical operations support from initiation to closeout
- Phase I–III support across multiple therapeutic areas
- Recruitment monitoring, site liaison, and issue tracking
- Regulatory-aligned documentation and reporting
Trial Master File (TMF) & Documentation Support
We manage TMF setup, maintenance, and QC with GCP-aligned workflows to ensure your trial documentation is always audit-ready.
- TMF setup, filing, and QC in line with ICH-GCP
- ICH-GCP compliance and eTMF platform familiarity
- SOP-driven support for global studies and submissions
Clinical Workflow Automation
The Future of Healthcare Starts with Smarter Workflows
Automated Patient Record Management
Manual documentation is time-consuming, error-prone, and inefficient, reducing the time clinicians can spend on patient care. Our AI-powered tools simplify note-taking, automate medical record updates, and ensure accuracy.
- Voice-to-text AI transcription converts speech into structured notes in real time
- Smart templates auto-fill medical records, reducing repetitive documentation
- OCR-based scanning extracts data from handwritten notes & prescriptions
Seamlessly integrated with EHRs via HL7 & FHIR, our AI-driven documentation tools ensure faster workflows, fewer errors, and a better clinician experience.
Seamless EHR & System Interoperability
Disconnected systems increase errors and slow down clinical workflows. Our solution ensures real-time data exchange across all platforms, from EHRs to lab systems, pharmacy networks, and diagnostic tools.
- FHIR-based interoperability for seamless data sharing
- Barcode & RFID-enabled automation for patient identification & prescription tracking
- AI-powered data validation detects inconsistencies & reduces reconciliation efforts
With complete integration across healthcare systems, clinics can eliminate manual data entry, improve accuracy, and ensure real-time information availability.
AI-Driven Decision Support & Predictive Analytics
Manual patient record reviews slow down decision-making and increase the risk of overlooked patterns in patient history. Our AI-powered insights give clinicians real-time, data-backed recommendations for better patient outcomes.
- Predictive analytics identifies high-risk patients for early intervention
- AI-assisted clinical decision support suggests treatment pathways
- Automated lab result analysis flags anomalies for quicker review
With real-time data insights and AI-driven recommendations, clinicians can improve diagnostic accuracy and provide more personalized care.
Pharmacovigilance
Delivering Safe & Compliant Pharmacovigilance Solutions
UK QPPV Services & PSMF Management
As per UK MHRA and EU EMA requirements, we offer QPPV services to ensure continuous safety monitoring and regulatory compliance. Our QPPV experts oversee Pharmacovigilance System Master File (PSMF) maintenance, EudraVigilance submissions, and risk mitigation strategies using Veeva Vault Safety and XEVMPD frameworks.
- 24/7 UK QPPV oversight for MHRA compliance & post-marketing safety reporting
- PSMF management & regulatory audits using MHRA e-Submission Gateway
- EudraVigilance registration, XEVMPD updates, and risk mitigation planning
Adverse Event Case Processing
We process Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) with AI-enabled safety databases, ensuring real-time compliance with UK MHRA reporting guidelines. Using Argus Safety and ArisGlobal LifeSphere, our team accelerates case triage, medical review, and expedited reporting while maintaining the MedDRA coding integrity.
- Automated AE case intake & validation for UK Yellow Card reporting & EudraVigilance
- Medical assessment & narrative writing for expedited MHRA compliance
- End-to-end ICSR lifecycle management integrated with WHO Drug Dictionary
Signal Detection & Risk Assessment
Using Empirica Signal, VigiBase, and PV Works, we monitor adverse event trends and emerging safety signals in compliance with GVP Module IX. Our AI-powered approach integrates real-world evidence (RWE) analytics, linking EudraVigilance safety reports with observational datasets for proactive risk assessment.
- Data-driven signal detection & trending analysis aligned with MHRA & EMA GVP guidelines
- Early risk identification through RWE analytics & machine learning models
- Regulatory signal evaluation & decision support using OpenVigil & WHO UMC databases
Periodic Safety Reports (PSURs, PBRERs, DSURs, RMPs)
We prepare and submit PSURs, PBRERs, DSURs, and RMP updates using AI-powered automation, ensuring full compliance with ICH E2E standards. Our team utilizes Argus Safety and MedDRA-coded datasets to streamline safety report generation and regulatory submissions via MHRA e-Submission Gateway.
- Automated safety report generation integrated with EVDAS & MHRA submission systems
- AI-enhanced risk-benefit assessment for regulatory decision-making
- Alignment with ICH E2E & GVP Module VII for UK & EU submissions
Literature Screening & Medical Writing
Our automated literature screening solutions leverage Embase, PubMed, and Elsevier PharmaPendium to identify adverse event reports and safety signals in scientific publications. Using natural language processing (NLP) algorithms, we extract key safety insights and prepare regulatory-compliant DSURs, PBRERs, and RMP updates.
- Automated literature screening for MHRA compliance with AI-powered NLP models
- Regulatory-compliant medical writing for PSMF, RMPs, and benefit-risk reports
- End-to-end signal documentation for EudraVigilance & Yellow Card Scheme submissions
EudraVigilance & Global Safety Database Submissions
We ensure full regulatory compliance with EudraVigilance, FAERS, and WHO UMC submissions by integrating Argus Safety and ArisGlobal LifeSphere with XEVMPD frameworks. Our automated workflows align E2B(R3) reporting standards with UK and EU pharmacovigilance regulations.
- Real-time ICSR reporting & aggregate submissions via EudraVigilance & MHRA portals
- Automated compliance tracking integrated with MHRA E2B(R3) electronic reporting
- Data integrity verification using WHO Drug Dictionary & MedDRA classification
Post-Marketing Surveillance & Real-World Evidence (RWE) Analysis
We integrate real-world data (RWD) and real-world evidence (RWE) from UK-based patient registries, NHS clinical databases, and observational studies to assess long-term drug safety and effectiveness. Using IBM MarketScan and Optum Clinformatics, we generate AI-driven safety analytics for risk-benefit evaluations.
- Post-market risk assessment using RWE models & NHS claims data
- Regulatory-compliant benefit-risk evaluations integrated with MHRA Yellow Card Scheme
- AI-powered real-world insights to support post-authorization safety studies (PASS)
MHRA Pharmacovigilance Inspections & Audit Readiness
Our PV audit and inspection readiness services ensure full MHRA compliance through mock inspections, CAPA planning, and regulatory training. Using Veeva Vault QMS and TrackWise Digital, we conduct GVP compliance assessments and gap analysis audits to identify potential risks before regulatory reviews.
- Pre-inspection MHRA compliance audits with GVP Checklists & risk assessments
- CAPA implementation & documentation alignment for pharmacovigilance systems
- Mock regulatory inspections using GxP audit tracking & AI-driven compliance platforms
Pharmacovigilance Consulting & On-Demand Regulatory Support
Access specialist pharmacovigilance consulting to address regulatory challenges, safety concerns, and MHRA compliance queries. Our team of QPPV professionals and pharmacovigilance experts provides real-time guidance on case processing, signal detection, risk mitigation, and regulatory reporting. With AI-driven regulatory intelligence platforms, we ensure quick, data-driven decision-making aligned with UK and EU GVP guidelines.
- Real-time QPPV oversight & regulatory support tailored for UK & EU compliance
- Expert-driven risk assessments & safety evaluations for post-market drug monitoring
- AI-powered compliance insights ensuring adherence to MHRA & EMA pharmacovigilance regulations
Regulatory Affairs & Compliance
Regulatory Intelligence & Submission Strategy
Keep pace with evolving global regulations through real-time regulatory monitoring tools like EMA, MHRA, and FDA regulatory portals. Our experts analyze IDMP, CTIS, and EU CTR frameworks to provide strategic guidance on submission planning and compliance risk mitigation.
- Track global regulatory updates using EMA & MHRA intelligence platforms
- Analyze competitor filings with Veeva Vault RIM & Lorenz DocuBridge
- Develop tailored market-entry strategies using eCTD and xEVMPD frameworks
Regulatory Due Diligence & Gap Analysis
Ensure your submissions meet ICH M4 and eCTD guidelines with our AI-driven regulatory document review and compliance assessments. Using Veeva Vault RIM, Lorenz eValidator, and eCTD Xpress, we detect inconsistencies, missing data, and areas for improvement.
- Assess dossier compliance with Lorenz eValidator & eCTD Xpress
- Identify submission gaps using automated regulatory tracking tools
- Generate remediation plans with AI-powered risk assessment models
Submission Management & Regulatory Filing
Optimize submission timelines with automated eCTD validation, error-checking, and real-time tracking using Extedo eSUBmanager and GlobalSubmit. Our experts ensure regulatory compliance across multiple regions, avoiding submission delays.
- Automate dossier preparation & validation with eCTD Xpress & Extedo eValidator
- Ensure regulatory compliance for eCTD & NeeS formats using Veeva Vault RIM
- Track submission progress & regulatory responses with Global RIM systems
Risk Management Plan (RMP) Revision
Enhance risk management strategies with real-time safety data integration using Empirica Signal, ArisGlobal LifeSphere, and PV Works. Our AI-driven approach updates RMPs based on post-marketing surveillance and ensures compliance with Good Pharmacovigilance Practices (GVP).
- Detect safety signals & adverse trends with Empirica Signal & PV Works
- Revise & optimize RMPs using ArisGlobal LifeSphere Safety
- Ensure compliance with GVP Modules V and IX via automated RMP reporting tools
Life Cycle Management in Europe & UK (Type IA, IB, II Variations)
Streamline post-approval regulatory processes with automated tracking and variation submission tools. Using MHRA e-Submission Gateway and EU Variation Tracking Systems, we ensure uninterrupted market access.
- Manage variations & renewals with Veeva Vault RIM & Lorenz DocuBridge
- Ensure labeling & SmPC updates using IDMP and xEVMPD frameworks
- Track regulatory updates & deadlines with MHRA’s e-Submission Portal
Aggregate Safety Report Submission (DSUR, PBRER, PADER, ACOs)
Ensure timely and compliant Aggregate Safety Report (ASR) submissions with automated reporting tools like Argus Safety, ArisGlobal LifeSphere, and MedDRA Coding Systems.
- Prepare & submit DSURs, PBRERs, PADERs, and ACOs with ArisGlobal LifeSphere Safety
- Automate regulatory tracking & deadline management using PV automation tools
- Integrate real-time safety data with MedDRA coding & WHO Drug Dictionary
MHRA Compliance Auditing & Inspection Readiness
Ensure MHRA compliance with pre-inspection audits, CAPA planning, and compliance training. Using TrackWise Digital and GxP Audit Tracking tools, we assess gaps and develop remediation plans before inspections.
- Conduct regulatory audits & compliance assessments with MHRA & EMA Checklists
- Simulate MHRA inspections & mock audits using GxP Audit Tracking Systems
- Develop corrective action plans (CAPA) with Veeva Vault QMS & TrackWise Digital
Regulatory Hotline Support
Resolve compliance challenges in real time with our regulatory hotline support, powered by automated regulatory helpdesk platforms. Our specialists offer instant guidance on submission strategies, compliance risks, and regulatory updates.
- Access 24/7 regulatory support via AI-powered compliance chatbots & helpdesk
- Receive instant insights on global regulatory frameworks with automated intelligence tracking
- Get expert-driven solutions for submission & compliance challenges
UK Market Entry & Regulatory Support
Streamline your UK regulatory approvals, clinical trials, and post-marketing compliance with automated market entry solutions. Using MHRA e-Submission Gateway and UK Clinical Trial Approval Systems, we ensure a seamless registration process.
- Secure UK product approvals using MHRA Submission Portals & eCTD Gateway
- Optimize clinical trial approvals via Veeva Vault RIM & GlobalSubmit
- Ensure UK-specific post-market compliance with Yellow Card Scheme integration