PHARMACOVIGILANCE
Like you, we also believe in “Safety First” concept. We walk with you to ensure vigilance is made convenient and compliance driven. We believe in service concept of “Reciprocal Safety”, which makes us preferred partner with any size of pharmaceutical organization. We are proud to be called as “Focused Medical Safety Partner” by our clients, based on our hands-on Medical Safety domain. We aim to achieve your goal for Patient’s well-being.
Clinical Trail Pharmacovigilance:
CT Initiation Support
Our CT and PV Experts, along with Medical Monitors, develop a pragmatic plan on safety management to foster correct safety information collection.
- Safety Management Plan (SMP)
- Site training for AE/SAE assessment and safety reporting
- 24*7 Clinical Site Inquiry Support
EU CT Portal Management Support
We provides RPEV services for their European CT partners. Oneiric has in-house RPEV, is certified with EMA knowledge certification, and has hands-on experience in managing EudraVigilance.
- RPEV (Responsible Person for EudraVigilance)
- CTIS Portal Management
- ASR Submission
CT AE/SAE Management
Our team of safety CT physicians and pharmacists manage AE/SAE right from case receipt to submission globally. With categorical experience in processing SUSAR with AOSE, trial compliance are in safe hands when CT Processing is considered. The team has experience working on five different safety databases, making them versatile to act as FSP experts as per necessity.
- AE/SAE Processing
- SUSAR Processing and submission
- AOSE Preparation
CT Medical Safety
We considers itself an expert when it comes to the Medical Safety aspect, as we have collective experience in supporting DSUR/ASR/LLR/DRMP preparation, expert review, and submission support.
Our experience varies from drugs, combination products, vaccines, biosimilars, biologics, nutraceuticals, and cosmetic products.
- Periodic Safety Listing Review
- SAR/SUSAR Line Listing Report
- Risk Management Strategies
- Development Safety Update Report (DSUR)
Post- Marketing Pharmacovigilance:
PB System Master File
The PSMF is a comprehensive PV system document providing a high-level overview of system hygiene. This is a paramount document for any product authorization in the EU, UK, CIS, APAC, and some of the MENA region countries. Our hands-on collective team experience in working on PSMF, PSSF, and PVMF has inbuilt procedural agility.
Our experts provide the following services:
- EU, UK, India, Rest of the World PV Master File Preparation
- SME Review of Master File
- PSMF Gap Analysis
Medical Information and Contact Centre
Oneiric provides Medical Information (MI) and contact center services via offshore (India) and onshore (USA) models with our highly trained healthcare professional MI Specialists, led by an industry expert. Our experienced team handles everything under the sun on Medical information. Our range of spectrum in MI Services includes:
Classical Services
- Intake and response Management
- Product Quality Complaint (PQC) Handling
- Patient Consent management
- Follow-up Management
Contact Centre writing
- Frequently Asked Questionnaire (FAQ) Development
- Standard Response Letter (SRL) Development
- Risk related Targeted Follow-up Questionnaire (TFUQ) Development
Expert Services
- REMS Contact Centre
- Drug Recall Management
- Mass Lawsuit Complaint receipt
- Patient Registries
- Cell/Gene Therapy Follow-up Module
Literature Monitoring
Literature monitoring is the heart of Hypothesis validation/strengthening activities. OIs conducts Automated weekly literature examinations in PubMed &/or EMBASE (per client selection).
We provide People, Process, and Automated Platform oriented Literature Services.
- Global Literature Monitoring for ICSRS
- Literature Monitoring in Safety Evaluation
- Pre-Authorisation Literature Monitoring
- Drug Event Pair Search and evaluation
- Literature for Annual NDA/ANDA Report
- Local Literature Search (for EU, APAC and LATAM countries)
Literature Automation features
- Argus Integrated E2B enabled- Automated Literature Monitoring Platform
- Automated tool works on Al, hence increases efficiency and precision over time
- Multi-Lingual Translation of Abstract as per need basis
- Fully automated-helping entire lifecycle tracking and communication
Case Processing
As the most scientific and priory activities, ICSR management needs multiple platforms trained team. OIs Research provides complete ICSR management services via an in- house/client hosting system.
Since case processing is dynamic and resource-driven, we support the client in the following aspects:
Case Intake and Processing Services
- EV WEB Downloading
- Case Intake and Booking
- Triaging of Cases
- Data Entry of ICSRs
Expert Services
- Peer Review (QC) of ICSRS
- Physician Review/Medical Review of ICSRs
- Medical Coding
- Narrative Writing
- ICSR Submission
Case Type Services
- True Spontaneous Case Processing
- Legal Case Processing
- Business Partner Case Processing
- Literature Case Processing
- CT Case Processing
- Regulatory Case Processing
Specialized Processing Support
- 10% Third Party QA
- Tracker/Admin Maintenance Support
- Project Management for ICSR
- Legacy Case Management
- PVA/SDEA cases reconciliation
Aggregate Report
Oneiric Internationals takes pride in calling itself a specialized medical safety research organization, as medical safety has been its subject matter expertise. Our aggregate universe includes authoring of Periodic Adverse Drug Experience Reports (PADERS), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURS), Canadian Annual Safety Report (ASRs), Benefit-Risk Evaluation Reports (BRERS), Addendum to Clinical Overview (AdCO) for renewal, Clinical Expert Statements (CESS), Summary Bridging Reports (SBRs) and PSUR Addendum Reports (APS).
Considering our SME status in medical safety, we support our clients as a complete report writing team (includes authoring, review, medical assessment, and submission) or as- needed SME review support.
Classical Aggregate Reports Services
- Scheduling
- Authoring
- SME Review
- Submission
Specialized Aggregate Reports Services
- Submission of RFI and PRAC assessment Report
- Line listings Review
- Regulatory Website review & tracking of PSUR report • Publishing of Report
MAH System Support
- GAP Anolysis/ Audit
- Oversight System Setup
- Workshop/Training
- Procedure Development
Risk Management Systems
Our experience in developing risk management system is very pragmatic for pharmaceuticals, biosimilars, combination products, Vaccines, Biologics, Digital Therapies, and ATMPS; this differentiates us from other CROS. Our agile process and experience of working with diverse companies put us as frontrunners when it comes to integration with sponsor’s safety CMO groups in arriving at comprehensive material-ready RMPs for submission to the regulatory agency.
Oneiric Internationals has team members who function as an expert in managing single shared REMS programs mandated by the FDA. We do provide professional assistance to our manufacturers through the REMS development process.
- Preparation (Core RMP, EU RMP, Local RMP, REMS)
- SME Review
- RFI response
- Risk Minimization Measures (RMM)
- Development and SME Review of additional RMMs (E.g. Educational Materials, DHPCs)
- ORMM tracking (per GVP Module XVI requirement)
- Effectiveness Evaluation report for RMM
- Single Shared System REMS expert Support