Safety

The collection, analysis, and processing of adverse events and incident reports need the best of many worlds – medically and scientifically trained staff, knowledge of local regulations, experience with the best industry practices, and competency with the leading safety databases. At ClinChoice, our case processing teams are geared to deliver our services with acuity and quality. Our services include:

• Automated tracking of open and missing cases
• End-to-end case management including intake, triage, data entry, quality review, medical review, and submissions followed by reconciliations
• Expedited reporting and submission status monitoring
• Serious adverse event report submissions
• Quality management systems, including inline and end-of-line QC processes
• ICSR download from Eudravigilance for case processing
• XML import into safety database for ICSR assessment
• E2B case reporting and archiving
• Automated Safety System implementation

A mature, scientific, and medically qualified literature monitoring service is crucial to identifying and annotating safety information for case processing, aggregate reporting, and signal management. ClinChoice’s staff has the wherewithal to perform global and local literature monitoring using the latest technologies to identify the relevant information imperative for advancing patient safety and product enhancement. Our services include:

• Search strategy development
• Create and maintain the search calendar
• Full text procurement and translation management
• Review and medical assessment and classification of literature reports
• Providing literature contributions to aggregate and signal management reports
• Management and archival of large volumes of literature

The development of high-quality reports needs highly skilled authors with strong product knowledge, a good grasp of regulations, and an affinity for technology. ClinChoice’s global authoring workforce has proven experience developing and reviewing safety reports drafted for different geographies, tailoring the documents to meet local requirements.

The team manages aggregate report calendar, defines data evaluation and presentation strategies in collaboration with stakeholders, extracts relevant data from the product vigilance database, conducts thorough technical and medical reviews, and adeptly responds to health authorities’ inquiries.

• 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

Detection of new uses of a product or determining if there are potential links between adverse events and a product requires a strong medical temper and deep knowledge of analytical methods. ClinChoice’s signal management teams have exceptional capabilities in working with small and large data sets using the latest technologies to identify potential signals that are necessary for continuous benefit-risk analysis and reporting. 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

Our pharmacovigilance specialists, equipped with extensive experience in European markets, offer comprehensive support for the preparation and maintenance of the Pharmacovigilance System Master File (PMSF) under GVP Module II, aligning with the requirements of EU Directive 2010/84/EU (amending 2001/83/EC). Our services include:

• PSMF template preparation
• PSMF content verification and periodic/ad-hoc updates
• Additional annex creation
• SOP authoring for PSMF maintenance
• Training material creation

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

The availability of skilled and experienced safety officers in different markets in Europe and other parts of the world has proven advantages beyond just complying with local regulations. Having the right people to provide seasoned oversight, quickly adapt to changing regulations, and respond to local emerging safety issues is necessary for ensuring the quality of operations and patient safety. ClinChoice has a network of LSOs who are available to support local pharmacovigilance operations and contribute to global safety initiatives apart from meeting regulations. Our services include:

• 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

Continuous oversight of local safety operations by a Qualified Person for Pharmacovigilance (QPPV)/Local Person for Pharmacovigilance (LPPV) is a regulatory requirement that needs to be met by market authorization holders. Beyond meeting the law by their availability, experienced and proficient QPPVs/LPPVs provide invaluable contributions to addressing safety issues that emerge regionally or locally. ClinChoice has a slew of QPPVs/LPPVs and deputy QPPVs/LPPVs who are available around the clock for health authorities and are ably supported by our offshore delivery centers to carry out their daily operations. Key responsibilities include:

• Review and curate local regulatory intelligence
• Develop and maintain the Pharmacovigilance System Master File (PMSF) and Safety Data Exchange Agreements (SDEAs)
• Establishment and maintenance of the marketing authorization
• Be the 24/7 point of contact for health authorities
• Prepare the organization for PV audits and inspections
• Support the creation and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to the health 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
• Authoring first-time right responses
• Independent quality review of calls
• Creation and maintenance of FAQs
• Product replacement and refund support
• Omnichannel support
• Expert product and device support
• Product launch expertise
• Patient support
• Multilingual support via translation services