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:
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|
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.
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.
Compliance with deadlines for expedited and aggregate reports is our top priority.
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).
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|
ADM PV team has various experiences in writing SMP and creating SMP documents for Clinical Trial, Post-Marketing and Medical Device.
We work together with client to minimize compliance gaps and to improve efficiencies in managing your safety data.
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.
We offer the following Preparation of RMP services:
|RMP Amendment||RMP Amendment|
ADM PV team has extensive experience in writing RMPs, setting risk categories, and assessing risk benefit analysis.
We can help our clients determine important identified and potential risks for both detailed and abbreviated risk management plans.
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.
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|
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.
Compliance with regulations and efficient safety information management based on discussions with clients.
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.
We offer the following service:
|Literature screening||Monthly updates for literature.|
Helping client to identify important signals through comprehensive and scientific literature screening.
SMP Development & Adverse Incident Management
Medical device vigilance is the collection, assessment, and reporting from the use of medical devices.
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|
ADM PV team has experience in reporting Adverse Events related to medical device in MFDS and NIDS.
We can help our clients comply with the regulations by carrying out Adverse Device Effects reporting tasks.
Expedited, Periodic reports
submission to CA
SMP details the roles,
responsibilities, processes, and
timelines for all safety activities.