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Case Processing & Reporting
Individual Case Safety Reports (ICSR) in Pharmacovigilance
The management of individual suspected adverse reactions and events is the basis of Pharmacovigilance and safety monitoring. We help you in the correct collection, processing, assessment, submission and follow-up of activities and reconciliations in all the following fields:
Service Scope
We offer the following case processing and safety reporting services:
Pre-marketing (Clinical Trials) Complete management and assessment of SAE/SUSAR Post-Marketing Complete management and assessment of ICSR Safety Reporting Safety Reporting to CA Service Contents
- Receipt and triage of ICSRs
- Data entry
- Medical assessment
- MedDRA coding
- Narrative production
- Analysis of Similar Events (AOSE)
- Quality control (QC)
- CIOMS generation and distribution
- Expedited and Periodic reports submission to CA
- Reconciliation with external, internal data
PV team strengths
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Experts in ICSR processing
Case processing is performed by qualified and highly trained pharmacovigilance staff following clear and comprehensive internal procedures for safety information management.
Our experienced pharmacovigilance staffs are involved in case processing, reviewing MedDRA coding, and carrying out full quality control of each report. -
Regulatory intelligence
Managing regulatory intelligence is a key part of appropriate pharmacovigilance. Therefore, we keep abreast of any changes in the local regulations and update our core regulatory reporting requirements accordingly.
Providing overall safety information management as per local regulatory requirements is our key services to client. -
Timeline compliance
Compliance with deadlines for expedited and aggregate reports is our top priority.
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Safety Management Plan
Safety Management Plan (SMP) Development
Safety Management Plan (SMP) is one of the most important documents because it regulates all safety communication between the Sponsor and the Contract Research Organizations (CROs).
Service Scope
We offer the following SMP development services:
Pre-Marketing (Clinical Trials) Safety Management Plan (SMP) development Post-Marketing Safety Management Plan (SMP) development Medical Device Safety Management Plan (SMP) development PV team strengths
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Specialized in SMP development
ADM PV team has various experiences in writing SMP and creating SMP documents for Clinical Trial, Post-Marketing and Medical Device.
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Maintain high standard of SMP
We work together with client to minimize compliance gaps and to improve efficiencies in managing your safety data.
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Risk Management Plan
Risk Management Plan (RMP) support for MFDS submissions
RMP describes the risk management system and contains information regarding identified risks, potential risks and missing information. It outlines any risk minimization measures adopted and includes information about monitoring the effectiveness of these measures.
Service Scope
We offer the following Preparation of RMP services:
RMP Development RMP Development - Safety Specification
- Efficacy Specification
- PV Monitoring Plan
- Risk Minimization Plan
RMP Amendment RMP Amendment Service Contents
- Setting risk categories such as important identified risks, potential identified risks, and missing information
- Summarizing and writing efficacy specification
- Reviewing and outline routine and additional pharmacovigilance plan
- Writing and development routine and additional risk minimization activities
PV team strengths
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Experts in RMP development
ADM PV team has extensive experience in writing RMPs, setting risk categories, and assessing risk benefit analysis.
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Identify evidence-based safety concerns
We can help our clients determine important identified and potential risks for both detailed and abbreviated risk management plans.
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Aggregate Reporting
Safety reports need to be prepared according to the GVPs and local legislation requirements. These documents allow the MAHs to comply with the specific safety monitoring of their product.
We are experts in safety reports and can support you in their preparation and monitoring.Service Scope
We offer the following preparation of Periodic reporting services:
Pre-marketing (Clinical Trials) DSUR: Development safety update report Post-marketing PBRER Periodic Benefit Risk Evaluation Report PSUR: Periodic safety update report RMP Implementation and Evaluation Report Service Contents
- Developing and maintaining periodic reporting schedule
- Drafting, medical reviewing, and formatting of reports
- Responding to any requests that may be arisen from authority
PV team strengths
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Responding to any requests that may be arisen from authority
ADM PV team is highly experienced in Periodic reports such as Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs) and RMP Implementation and Evaluation Reports in accordance with MFDS guidelines.
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Maintain high quality of aggregate reporting
Compliance with regulations and efficient safety information management based on discussions with clients.
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Literature screening
The scientific and medical literature is an important source of information for the safety profile of medicinal products, especially in the detection of new safety signals or emerging safety issues (ESI). We perform literature on a local and international level search.
Service Scope
We offer the following service:
Literature screening Monthly updates for literature. PV team strengths
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Specialized in literature screening
Helping client to identify important signals through comprehensive and scientific literature screening.
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Medical Devices Vigilance
SMP Development & Adverse Incident Management
Medical device vigilance is the collection, assessment, and reporting from the use of medical devices.
Service Scope
ADM PV team provides a full range of services for both device clinical trials and post-marketing medical devices needs.
Safety Management Plan (SMP) development Safety Management Plan (SMP) development Case processing Complete management and assessment of ICSR Safety reporting to CA Safety Reporting to CA Literature screening Monthly updates for literature Service Contents
- Safety Data Management
- Adverse Device Effect (ADE) and Medical Device Incident (MDI) case processing, coding, and follow-up
- Narrative production
- Quality control (QC)
- MedWatch creation and distribution
- Device Vigilance Report preparation and submission to MFDS and NIDS
- Literature search and review
PV team strengths
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Specialized in Medical Device Vigilance
ADM PV team has experience in reporting Adverse Events related to medical device in MFDS and NIDS.
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Processing Medical Device Vigilance
We can help our clients comply with the regulations by carrying out Adverse Device Effects reporting tasks.
Pharmacovigilance
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Case Processing
& Safety Reporting
Individual Case Safety Reports (ICSR) in Pharmacovigilance
Expedited, Periodic reports
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submission to CA -
Safety Management Plan
(SMP)
Safety Management Plan (SMP)
DevelopmentSMP details the roles,
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responsibilities, processes, and
timelines for all safety activities. -
Risk Management Plan
(RMP)
Risk Management Plan (RMP)
support for CA submissionsRMP Development
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RMP amendment -
Aggregate Reporting
RMP Implementation and Evaluation Report Preparation
PSUR/PBRER Preparation
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DSUR Development -
Literature screening
Searching literature on a local and international level
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Medical Devices Vigilance
SMP Development
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&
Adverse Incident Management