概要

FMD K&Lグループはインドやフィリピンのデリバリーセンターからローコスト&高品質のファーマコビジランスサービスを提供しています。

サービス例
  • Case Processing
  • Aggregate Reporting
  • Risk Management
  • Signal Detection & Risk Management
  • SDEA Management
  • Literature Management
  • Medical Information Call Center (MICC)
  • Clinical Medical Writing
  • Identification of Medical Products (IDMP)
  • Medical Translation

システム経験

  • 社内にARGUSを導入済
  • 経験済安全性情報管理システム:- ARISg, – ClinTrace, – Empirica, – その他顧客開発のシステム
  • クライアント固有のニーズに合わせたカスタムツール、プラグイン、DBソリューションの開発
    顧客に代わってシステムの構成変更

実績

  • 複数の契約を合計し、一カ月に10,000以上のケース処理
  • Signal Alerts: 500件/月
  • 150件/年 集計レポート作成、scientific and medical writing documents authored & reviewed
  • 100% 顧客と規制当局の設定した期日どおりに提出
  • 98.5%の報告ににエラーなし

実績一覧

主な経験領域:Cardiovascular, Oncology, Immunology, Infection, Respiratory, Dermatology and Pain

有害事象管理

Data Transformation

Case Data Line listing from APAC/EMEA/LATAM Regions.
Managed over 27,000 cases including AE, PQC & MI.

Safety Assessment in Clinical Trials

Clinical Trial Program involves over 200 products and 150 clinical trials.
Clinical sites spread across NA, EMEA, LATAM & APAC.

Global Case Management

End-to-End Pharmacovigilance process from Triage to Submission
Managed over 6,000 Individual Case Safety Report
Submitted over 100 MedWatch reports to US FDA
Regions: NA, LATAM, Canada, EMEA & APAC

Legal Case Processing

End-to-End Pharmacovigilance process from Triage to Submission
Target 12,000 cases per year

Literature Search

Performed over ,3500 literature searches
Draft narratives and provide MedDRA coding for all the events
Signal detection and trending of the events
Triage to Submission : End to End Pharmacovigilance

PQC Remediation

Review of Issue with limited PQC investigation data.
Managed over 1200 cases per month

Draft Aggregate Reports

PBRER, PADER, Addendum to Clinical Overview (ACO), Ad-hoc reports
Draft aggregate reports for consumer products that meet company & regulatory requirements

Quality Check of Aggregate Reports

PBRER, PADER, Addendum to Clinical Overview (ACO), Ad-hoc reports
Develop checklist to ensure all sections are completed in the reports
Ensure templates and style guidelines are followed
Provide feedback to writers as appropriate

Risk Management Plan

Authored Risk Management Plan for 4 product
Quality review of Risk Management Plan’s
Underwent extensive Client SOP training for drafting the RMP

Signal Detection

Focus area – Consumer products
Reviewed 15000 alerts
Identified 8 signals
Regions -NA, EMEA, LATAM & APAC

リソース詳細

100人以上の安全性情報処理専任スタッフ
PhD、医師、看護師、薬学修士またはサイエンス関係の修士を持ったメンバーで構成
30%のスタッフは5年以上の業務経験あり
ARGUSを利用したこれまでの処理件数は250,000件以上

経験年数

 

背景

ICSR処理

1. Triage and Case book-in

Duplicate search
Basic entry and validation of initial fields
Multiple case creations from literature
Case prioritization
Seriousness
Pregnancy
Watch list
Special reporting criteria cases
SUSAR identification

2. Case Processing

Completion of data entry
Coding (WHO DD and MedDRA)
Labeling
Causality assessment
Narrative writing
Real time feedback to triage

3. Case Review

Validate all the fields according to the source document
Real time feedback to the case processor
Analysis of quality trends

4. Medical Review

Review of medical related fields:
MedDRA coding (listed, seriousness, causality)
Narrative recheck
Medical evaluation comments
Real time feedback to case processor

5. Submission

Prioritize submissions to Regulatory and PV License partners
E2B compliance

社内SOPおよびポリシーの例

CATEGORY NUMBER
General Policy POL-GM- (001 – 006)
General Procedure SOP-GM- (001 – 006)
BioStat – Programming SOP-BS- (001 – 004)
SOP-PROG- (001 – 002)
Data Management SOP-DM- (001 – 026)
IT Management SOP-IT- (001 – 008)
QA SOP-QA- (001 – 011)
Clinical Operations SOP-CO- (001 – 015)
Pharmacovigilance SOP-SA- (001 – 006)