Pharmacovigilance

PHARMACOVIGILANCE

CLINEXEL team members have extensive experience with GVP and PADE inspections conducted by the USFDA, Health Canada, TGA, EMA, MHRA & BfArM. We are conducting end to end pharmacovigilance operations for multiple Pharma companies for the US FDA and India compliance, including case processing, periodic reports, literature monitoring, signal detection, preparation of risk management plans and evaluation of additional pharmacovigilance activities and additional risk minimization measures.

Pharmacovigilance Operations(End to end Pharmacovigilance Operation services)

Pharmacovigilance Systems Master File (PSMF)

✔ Preparation, authoring and maintenance of PSMF

QPPv Services

✔ EU-QPPV/ QPPV/ Local Safety Officer services for EU, CIS countries, MENA and LATAM

✔ Point of Contact for Request for Information from Competent Authorities

✔ KPI Monitoring

✔ Point of contact for Local GVP Inspections

✔ Local Regulatory Intelligence

✔ Local Literature searching

✔ Compliance monitoring

ICSR Processing:

✔ End to end management of case processing

✔ All activities starting from case triage, data entry, quality control, MedDRA coding, medical review, reportability assessment, regulatory submission, and follow-up

✔Experienced Pharmacovigilance Physicians review all cases

✔Ensuring Compliance better than industry standards

✔ High-Quality Narratives

✔ 100% QC check

Periodic safety Reports

✔ Experienced writers at CLINEXEL help in preparing periodic safety reports

✔ Compliance monitoring

✔ Calendar management and planning of safety reports

✔ Complete authoring and production as per the required format PBRERs/ PADERs/ PSURs/ ASRs/ SBRs/ Addendums

✔ Authoring of DSURs

✔ Quick turn-around time to meet stringent timelines

Signal Detection & Analysis

✔ Identification and Prioritization of signals from company database

✔ Assess Individual case and aggregate reports for signal evaluation

✔ Medical monitoring of safety signals on a monthly or quarterly basis

✔ Complete work of signals including signal evaluation, literature review for epidemiological inputs and closing of signal

✔ Preparation of Signal Evaluation Reports

✔ Communication of Signal to Regulatory Authorities

✔ Preparing DHCP communications

Risk Management Plans

✔ Required for all dossier submissions

✔ Quick turn-around time for authoring and preparation of RMPs

✔ Designing of Risk Minimization Measures, including websites, Educational materials, medication guides etc

✔ Effectiveness analysis for RMMs with the help of Surveys and Testing

Literature Searching

✔ Weekly/ Ongoing Literature search

✔ Identification, triage & processing of Literature hits

✔ Integration with case processing and 100% reconciliation

✔ PSUR Literature search and analysis

Safety Data Exchange Agreements (SDEAs)

✔ Preparation of SDEAs customized per country specific regulatory requirements.

✔ Review of SDEAs

✔ Set up/ fine tune processes to ensure compliance with SDEAs

Safety- Medical writing

✔ Analysis of Similar Events

✔ Causality Assessments

✔ Preparation of FAQs

✔ Benefit Risk Assessments

✔ Integrated Safety Summary (ISS)

✔ Safety Sections of Clinical Trial Reports

✔ Clinical Overview & Clinical Summary

✔ Preparation, authoring & maintenance of PSMF

Quality & Compliance

✔ Review & manage Compliance metrics for key PV activities

✔ Develop & Implement Quality Management System (QMS), including preparation/ review of SOPs, Work Practices

✔ Closure of inspection findings: Identify and Prioritize improvements & CAPA support

Drug Safety in Clinical Development

✔ Highly experienced and trained drug safety physicians for the management of drug safety from clinical trials.

✔ 24/7/365 support by drug safety physicians for investigators

✔ High quality and cost- effective services during all phases of Clinical Development

Study start up activities

✔ Authoring safety sections of clinical study protocols.

✔ Set-up of Serious Adverse Event reporting procedures

✔ Training of the Investigators and CRAs.

✔ Preparation of Investigator Serious Adverse Event Manual.

Serious Adverse Event Management

✔ Initial event receipt and triage.

✔ Case processing, including data entry, narrative generation, and quality.

✔ MedDRA coding

✔ Analysis of Similar Events (AOSE)

✔ Submission of SUSARs to relevant regulatory authorities

✔ Reconciliation: Periodic Reconciliation of safety database with eCRF

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