QPPV/ARP Services
Expert oversight is a crucial success factor for the compliant PV system. Comprehending this fact, we have curated specific contact person services globally, spanning 35 countries. Our contact person services include the following regions EU, UK, MENA, APAC, CIS, Oceania, and LATAM.
COD has in-house EUQPPV, UKQPPV/NCP, and Pharmacovigilance Officer of India (PvOI).
Our length of contact person service includes:
● EUQPPV
● UKQPPV/NPC
● European Local QPPVs/NPRPs/LRPs
● QPPVs for MENA/GCC/CIS regions
● QPPVA
● Responsible Person for LATAM
As we have Ex-EUQPPV as our operational lead, we have integrated the QPPV office to provide heightened QPPV oversight support.
● Integrated QPPV Compliance Office (IQCO)
○ Oversight report Preparation
○ Compliance Assurance tracker
○ QPPV Advisory support
PV 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
COD 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. COD Research 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 AI, hence increases efficiency and precision over time
● Multi-Lingual Translation of Abstracts 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. COD 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 Reports
COD Research takes pride in calling itself a specialized medical safety CRO, 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 (ARs).
We are truly global in supporting our clients, as we support EU, USA, UK, ROW, and India reports. Our team’s cumulative experience stands at writing more than 1500 such reports.
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 Analysis/ 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.
COD Research 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).
○ aRMM tracking (per GVP Module XVI requirement)
○ Effectiveness Evaluation report for RMM
● Single Shared System REMS expert Support
Signal Management
We have the capability to execute signal management activities, including tool based/qualitative detection, validation, analysis and prioritization, signal assessment, and recommendation for action.
Our signal management review includes four periods of safety data review, including cumulative safety data by experienced drug safety personnel/physicians.
Our team also provides support for safety management teams meetings, where decision-making tree drawings are supported. Considering ourselves as writing experts, we naturally support signal evaluation and assessment report writing. The process can be customized and tailored to match the requirements of the client size.
● Signal Detection & Validation (Qualitative and Quantitative) output reviews
● Signal Evaluation Report Preparation & SME Review
● Expert Support for Larger Database Reviews (FAERS, EVDAS, MedEffect)
● Handling of Regulatory recommendations and prioritization
Alliance Partner Management
COD Research considers itself proficient when it comes to vendor/affiliate management. We have an experienced team working on SDEAs/PVAs (drafting and tracking) for our clients. As an overall PV service provider, we understand PV commitments mentioned in SDEAs/PVAs and their compliance impact.
Our operations and QA team have an extensive background of more than 725 + SDEAs management over a work profile.
● PV Agreements/SDEAs
● Vendor/Alliance Management
● Compliance Management
We have processes with ready templates for agreements and tracking mechanisms for ensuring agreement compliance.
Tactical Project Management
Management of overall operations is imperative for any safety team’s success. Hence, we came up with unique services to reduce your administrative and management burden so that you can focus on scientific vigor. Our lines of services are as follows:
Project Management (PM) Support
● PM ICSR Support
● PM Medical Safety Support
Drug Safety Coordination
● Business Partner coordination
● Safety Strategy support
● Safety Signal/review meeting coordination
Repository Management
● Larger Mailbox Management
● Action log identification and coordination
● Mass Lawsuit Complaint receipt
● Patient Registries
● Cell/Gene Therapy Follow-up Module
Tracker Maintenance
Regulatory Portal Management
We at COD Research have experienced team members on global regulatory portals like FDA ESG, EvWeb, XEVMPD, UK submission portal, and many others on the list. Holding Eudravigilance certification is a metaphorical feather in the COD Research team's hat of achievements. We can support and guide our clients to develop and manage their regulatory portals depending on expectations.
We have experience in managing:
● xEVMPD
● IDMP Preparedness
● CPNP portal
● SPOR
● OMS
● EudraVigilance user management
● CTIS
● UPD
● ESG
● MHRA submission and ICSR submission portal
● PSMF Location registration (MFL)
Insights &
Resources
Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
