Safety

ClinChoice reduces patient risk by leveraging product knowledge and industry best practices to meet stringent adverse event reporting and management requirements. The modularity of our offerings allows the selection of individual services or an end-to-end solution in post-marketing surveillance. Our specialists are proficient in safety databases such as Argus and LifeSphere Safety, among many others.

• End-to-end case management, including intake, triage, data entry, quality review, medical review, and submissions followed by reconciliations
• Expedited reporting and submission
• Case processing operations oversight and reporting
• Eudravigiliance monitoring, download and processing
• Safety System Management
• Reconciliation with business partners and affiliates

The exponential increase in publications documenting adverse events has increased the need for pharmaceutical and biotech companies to expand their literature surveillance operations. ClinChoice’s highly experienced and qualified staff offers best-in-class support for identifying ICSRs, articles supporting benefit-risk assessment and identifying potential signals in global and local databases as approved by regulators or agreed with the client organisation. The team is also experienced in screening and triage of EMA MLM reports. Our services include:

• Search strategy development
• Create and maintain the search calendar
• Full text procurement and translation management
• Through medical assessment and classification of literature reports
• Identify literatures meeting the criteria for aggregate reports and potential signals
• Management and archival of large volumes of literature

Expert analysis of adverse events and authoring high-quality aggregate reports are pivotal in accelerating patient safety initiatives and advancing product improvement. ClinChoice has authors with impeccable scientific and medical pedigrees who are responsible for developing, reviewing, and submitting safety reports to health authorities.

Our expertise extends to efficiently managing aggregate report calendars, defining data evaluation and presentation strategies in collaboration with stakeholders, extracting relevant data from the pharmacovigilance database, conducting thorough technical and medical reviews, and adeptly responding to inquiries from health authorities.

• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Periodic Adverse Drug Experience Reports (PADERs)
• Addendum to Clinical Overviews (ACO)
• Canadian Aggregate Reports (CARs)
• ROW/Regional PSURs (LATAM, UAE, India, Australia, South Africa)
• China Periodic Risk Evaluation Report (PRER)
• Summary Bridging Reports (SBRs)
• PRAC and health authority responses
• Benefit-risk profile reports
• Ad-hoc safety reports
• Local and EU Risk Management Plans (RMPs)
• Data analysis and risk communications
• Periodic CCDS/CCSI updates
• Safety labeling update justification document

Continuous risk identification and evaluation requires robust signal detection and management practice that expertly uses various safety data sources for quantitative or qualitative analysis. ClinChoice has a highly skilled global team that assesses every element of adverse event data to identify patterns and propose new safety measures based on signals validated. Our services include:

• Data mining and analysis from sources including, but not limited to, FAERS, VigiBase, and EVDAS
• Signal detection
• Signal validation
• Signal prioritization
• Benefit-risk assessment

ClinChoice draws from its extensive experience in supporting safety operations in Europe to provide oversight and update the Pharmacovigilance System Master File (PMSF) under GVP Module II, aligning with the requirements of EU Directive 2010/84/EU (amending 2001/83/EC). The QPPVs and LSOs collaborate with regional stakeholders to ensure that the PSMF is updated and audit ready. Our services include:

• Preparation of the the PSMF and periodic updates
• Additional annex creation
• SOP authoring for PSMF maintenance

ClinChoice’s specialists have experience reconciling and updating Safety Data Exchange Agreements (SDEAs) across all the operating geographies of marketing authorization holders and other partners. We bring leading technology and medico-legal experience to ensure comprehensive SDEA management.

• Paper SDEA digitization
• SDEA reconciliation
• Global SDEA template creation
• New SDEA coordination and authoring
• Existing audit review
• Active SDEA maintenance

Having a strong understanding of regional pharmacovigilance regulations and being able to implement changes to comply with health authority requirements is necessary for pharmaceutical and biotechnology companies as they enter new markets independently or through partnerships. ClinChoice provides experienced LSOs who proactively approach drug safety surveillance and regulatory compliance while staying updated on the latest EU and local safety regulations.

• SOP and work instruction compliance in local pharmacovigilance operations
• Receipt and oversight for adverse event reporting via telephonic call, hotline, email, company website, and social media screening
• Local process optimization for adverse event reporting
• Compliance to SDEAs
• Case reconciliation with internal and external partners
• Local labeling change review
• Provision of appropriate safety-related information in response to external queries
• Training for key personnel, including external partners and distributors, to comply with PV agreements
• Preparation and implementation of local risk management plans and mitigation measures
• Support for the submission of reports to local authorities
• Inspection readiness and oversight of deviations/CAPAs

Marketing of drugs in different parts of the world, including the European Union and the United Kingdom, requires the availability of a QPPV (Qualified Person for Pharmacovigilance)/ LPPV (Local Person for Pharmacovigilance) and deputy QPPVs/LPPVs. ClinChoice uses its grid of QPPVs/LPPVs and deputy QPPVs/LPPVs to alleviate the added responsibility of identifying experienced officers who are well-grounded in local regulations and compliance requirements. Key responsibilities include:

• Review and curate local regulatory intelligence
• Develop and maintain the PMSF and SDEAs
• Establishment and maintenance of the marketing authorization holder’s pharmacovigilance system
• Be the 24/7 point of contact for health authorities
• Responsible for ensuring readiness for PV audits and inspections
• Accountable and is the authority for the RMPs and aggregate reports prepared and submitted
• Oversight and accountable for all the products assigned
• Prompt and appropriate communications with the regulatory authorities

ClinChoice’s Medical Information Call Center Service excels in efficiently managing medical information requests, promptly identifying adverse events (AEs) and incident reporting, and precisely handling product quality complaints (PQCs). Our specialists are dedicated to processing and documenting AEs and PQCs within agreed timelines, ensuring seamless facilitation of product safety profile analyses.

Our medical information call center capabilities are coupled with our in-house case processing operations to accelerate the submission of critical safety updates to health authorities. Our services include:

• Management of call intake, triage, and follow-up
• Documentation of calls and request fulfillment
• Developing first-time right responses
• High quality outcomes
• Patient/Subject Centric
• Creation and maintenance of FAQs
• Omnichannel patient support
• Expert product and device support
• Multilingual support via translation services