Pharmacovigilance

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

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.

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

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.
Maintain high standard of SMP

We work together with client to minimize compliance gaps and to improve efficiencies in managing your safety data.

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

Experts in RMP development

ADM PV team has extensive experience in writing RMPs, setting risk categories, and assessing risk benefit analysis.
Identify evidence-based safety concerns

We can help our clients determine important identified and potential risks for both detailed and abbreviated risk management plans.

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

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.
Maintain high quality of aggregate reporting

Compliance with regulations and efficient safety information management based on discussions with clients.

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
Specialized in literature screening

Helping client to identify important signals through comprehensive and scientific literature screening.

Literature screening	Monthly updates for literature.

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

Specialized in Medical Device Vigilance

ADM PV team has experience in reporting Adverse Events related to medical device in MFDS and NIDS.
Processing Medical Device Vigilance

We can help our clients comply with the regulations by carrying out Adverse Device Effects reporting tasks.