This document describes pharmacovigilance services offered by Provenance Research, including: 1) Expertise in processing adverse events from clinical trials and post-marketing sources, including case creation, triage, data entry, follow up, and MedDRA coding. 2) Medical review and assessment of cases including causality assessment and signal detection. 3) Regulatory reporting including expedited reports, periodic safety reports, and literature searches.

1. VIGILANCE
Pharmacovigilance Services
PROVENANCE PHARMACOVIGILANCE
SERVICES ADVERSE EVENTS PROCESSING
Provenance Research offers comprehensive Our Pharmacovigilance experts specialize in the
pharmacovigilance services to pharmaceutical, management of both clinical trial and post-marketing
biotechnology and medical device companies across AE’s and offer complete support from case creation
their product’s lifecycle. Our pharmacovigilance to submission. We process cases in either the client’s
team consists of healthcare professionals with database or our database.
wide clinical, as well as drug safety experience
DILIGENCE
spanning multiple therapeutic areas. The dedicated CASE CREATION AND TRIAGE
team of pharmacovigilance associates, scientists,
and physicians are experts in recognizing, • 24/7 call centre support for collecting adverse
processing, analyzing and reporting adverse events. event reports from clinical trials and post-
marketing sources
• Triage of cases based on seriousness and
PROVENANCE ADVANTAGE expectedness
• Expertise that covers both pre and post
marketing pharmacovigilance. CASE PROCESSING
• Comprehensive SOPs, Quality Management • Entry of adverse event data
Systems, and Compliance measures maintain • Active query and follow-up of cases
the pharmacovigilance system audit and • MedDRA coding
COMPLIANCE
inspection ready. • Safety narrative writing and quality check of
case reports for data completeness
• Significant reduction of costs for the client
that can be allocated to their R&D.
MEDICAL REVIEW
• Electronic adverse event reporting
capabilities. • Qualified physician review of the cases for
completeness, accurateness, and capture of all
• Application of good pharmacovigilance medical concepts
practices and integration of new regulatory • Medical assessment/Causality assessment
and technical developments to the system. • Signal detection and Benefit-Risk analysis
SUBMISSIONS
PERFORMANCE
• Adverse events tracking and routing
• Expedited reports submission to regulatory
authorities
• Regulatory reporting to authorities,
investigators, and ethics committees

2. Engagement model
Location
DILIGENCE CORPORATE OFFICE
Provenance Research India Private Ltd.
“JP & Devi Jambukeshwar Arcade,
Provenance provides customized and cost-effective Ground Floor, No 69, Millers Road,
pharmacovigilance solutions based on the requirement Bangalore-560052
of the clients. We adapt our processes to match the Phone: 080-40838809
client’s processes and practices to ensure that quality, email: info@provenanceresearch.in
Our mission timelines, and regulatory requirements are met. www.provenanceresearch.in
“A vigilant today for a safe tomorrow”
Total Pharmacovigilance Solution
Provenance offers complete database services for
PERIODIC REPORTS collecting, analysing and reporting adverse events
supporting multiple studies or products. We utilize
• Annual safety reports a fully validated, ICH E2B and 21 CFR part 11
• IND Annual reports compliant database that has multiple functionalities
• Periodic safety update reports and supports SUSAR’s, ICSR’s, CIOMS I Reports,
• Addendum reports MedWatch Reports, CIOMS Line Listings and
• Bridging reports Tabulated Summaries. We can employ our
• US Periodic reports comprehensive SOPs and engage dedicated resources
to act as the drug safety department of your company.
LITERATURE SEARCH
• Running searches for literature on client Flexible Outsourcing Solution
products from online bibliographic databases
• Entry of identified cases into the safety database Provenance provides flexible outsourcing solutions
• Literature searches for the purpose of inclusion
COMPLIANCE
to clients to meet their regulatory commitments. We
in PSUR, evaluating safety issues and signals. can complement the client’s drug safety department
by providing part pharmacovigilance services, or as
and when needed services to meet their productivity
metrics during periods with spike in volumes. We
TRAINING SERVICES can work in the client’s safety database following
their SOPs and work instructions helping them
• Short-term training programmes in reduce their time and cost significantly. Be it ICSR
Pharmacovigilance processing, Periodic reports, or literature search that
• Certificate course in Pharmacovigilance you require, we can be your trusted safety partner.
VIGILANCE