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Drug Safety

Avoid Unexpected Adverse Events & Changes to Regulatory Reporting Requirements

ClinChoice specializes in product safety and risk management solutions for pharmaceuticals, biopharmaceuticals, medical devices, and cosmetics. To limit your exposure to risk, we provide a highly qualified team of experienced physicians and healthcare professionals focused on delivering expert pharmacovigilance, cosmetovigilance, and materiovigilance services.

Case Processing

ClinChoice offers proven scientific and medical expertise in over 20 therapeutic areas across the lifecycle of drugs to deliver on our commitment to patient safety.

We reduce patient risk by leveraging our blend of product knowledge and industry best practices to meet the most stringent requirements for adverse event reporting and management.

We provide exceptional prowess at each stage of case processing:

  • Intake
  • Triage
  • Data Entry
  • Quality Review
  • Medical Review
  • Submissions

The modular design of our offerings allows the selection of individual services or an end-to-end solution for adverse event reporting and management in the early clinical trial phases to post-marketing surveillance.

Our specialists have proficiency in Argus, ARISg/LifeSphere Safety, and other safety databases.

We enhance our ICSR management capabilities by providing the following services:

  • Medical information call center (MICC) management
  • Safety literature searches for identification of ICSRs
  • Automated tracking of open and missing cases
  • Monitoring of expedited reporting and reporting of submission status
  • Submission of serious adverse event reports to health authorities
  • Quality assurance
  • E2B case reporting & archiving

Aggregate Report Development and Submission

ClinChoice offers accomplished authoring and quality review services to prepare and submit aggregate reports that comply with global and local regulatory requirements for drugs and drug-device combinations.

Our team of safety and regulatory experts adopt a collaborative approach to create high-quality periodic and ad-hoc safety reports.

We have extensive experience in:

  • Periodic benefit/risk evaluation reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Post-marketing safety Report
  • Integrated Summaries of Safety (US)
  • Canadian Aggregate Reports (CARs)
  • Summary bridging reports (SBRs)
  • Periodic adverse drug experience reports (PADERs)
  • PRAC/health authority responses
  • Developmental safety update reports (DSURs)
  • Benefit/risk profile reports
  • Literature search, analyses, and ad-hoc benefit/risk assessments
  • Data analysis and risk communications
  • Subject matter expertise for risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS)
  • Risk Minimization Plans (RMP)

Over the years of our service, we have excelled in managing the aggregate report authoring and submission process. We partner with our clients in:

  • Maintenance of the aggregate reporting calendar
  • Generation of listings from the pharmacovigilance database
  • Technical and Medical Review of the reports
  • Response to health authority queries

Literature Monitoring

ClinChoice performs thorough searches in medical and scientific databases to analyze relevant safety information for continuous risk management.

Our literature search specialists perform meticulous surveillance by applying search strategies to identify precise and complete safety information for case processing, aggregate reporting, and signal detection.

Literature Sources that we use:

  • Public & commercial databases
  • Meeting & journal article abstracts
  • Published studies
  • Publications from congresses, conferences, and trade shows
  • Literature from registries, studies, regulatory agencies, or drug & poison centers

Our services support

  • Creation of search strategies
  • Local and global literature monitoring services
  • Analytical writing for summaries
  • Literature protocol and reports

Risk Evaluation and Mitigation

ClinChoice analyzes safety data to create risk management reports for submissions to health authorities for new product registrations and continuous labeling updates.

Our team of physicians and product specialists collaborate to design and prepare risk mitigation plans (RMPs) and risk evaluation and mitigation strategies (REMS) to support marketing authorization applications to the FDA and EMA. Our objective is to identify potential problems and address any issues that may arise before they escalate.

Our experience includes preparation of:

  • Safety information reviews & revisions
  • All sections of medical assessments
  • Full safety profiles
  • Risk-related position papers
  • Risk-benefit evaluations
  • Integrated summaries of safety (ISS)
  • Product expectedness lists

Our safety experts are also qualified to assist you with:

  • Oversight & tracking of medical monitoring
  • Thorough literature searches & assessments of epidemiology
  • Identification of significant risks & missing information
  • Reviewing & determining adequate routine and additional risk minimization measures
  • Creation of submission-ready RMPs
  • Assessment checks to document the effectiveness of risk mitigation strategies

Safety Data Exchange Agreements (SDEAs)

ClinChoice supports the lifecycle of safety data exchange agreements – from creation to updates to archival with a combination of technology and medico-legal expertise.

Our specialists have experience reconciling and updating SDEAs across all the operating geographies of the marketing authorization holders and other partners.

Our services include:

  1. Digitization of paper SDEAs
  2. Reconciliation of SDEAs
  3. Creation of global SDEA templates
  4. Co-ordination and authoring of new SDEAs
  5. Review of existing audits for assignment of responsibilities and updates of terms
  6. Maintenance of active SDEAs
  7. Authoring of SOPs for the governance of SDEAs

 

Pharmacovigilance System Master File (PSMF)

ClinChoice leverages its experience and presence in Europe to expertly maintain the pharmacovigilance system master file in compliance with EU Directive 2010/84/EU (amending 2001/83/EC).

With their deep understanding of EU regulations, our pharmacovigilance specialists provide all the necessary support to prepare and maintain the PMSF under GVP Module II.

Our services include:

  1. Preparation of the PMSF Template
  2. Verification and update of the PMSF content, including but not limited to the details of the QPPV, organization structure of the marketing authorization holder, safety data sources, pharmacovigilance systems and databases, system performance, and processes
  3. Creation of additional annexes as required
  4. Authoring of SOPs for PSMF maintenance
  5. Creation of training material

Medical Information Call Center (MICC)

ClinChoice expertly provides end-to-end management of medical information call centers with highly trained safety and product specialists.

Our Medical Information Call Center Service can efficiently manage medical information requests, identify adverse events (AEs)/Incident reporting, and product quality complaints (PQCs). The specialists are able to process and document AEs and PQCs in the agreed timelines to facilitate the analyses of the product’s safety profile. Our delivery centers are equipped to provide round-the-clock support with multi-lingual support to engage with patients, healthcare professionals, and other stakeholders.

We are fully capable of providing the appropriate medical and product responses with auditable communications based on a strong understanding of the products.

ClinChoice has experience in coupling our medical information call center capabilities with our in-house case processing operations to accelerate the submission of critical safety to health authorities.

Our services include:

  1. Set-up of medical information call center
  2. Management of call intake, triage, and follow-up
  3. Documentation of calls and request fulfillment
  4. Transfer of AEs, PQCs, and medical information queries
  5. Independent Quality Review of calls
  6. Creation and maintenance of FAQs
  7. Product Replacement and Refund Support
  8. Training of MICC specialists

Local Safety Officer (LSO) Services

ClinChoice places highly trained and experienced local safety officers to support regional pharmacovigilance activities and engage with health authorities.

Our LSOs will be responsible for regulatory compliance of all the pharmacovigilance activities in their assigned locations. In addition to being the client’s local representative for pharmacovigilance, the officers will enhance the quality of the regional drug safety operations and liaise with regulatory affairs to meet compliance requirements.

Our LSOs remain abreast with the latest EU and local safety regulations with the support of our in-house PV intelligence team.

Some of the responsibilities of the LSOs will be:

  1. Compliance with local pharmacovigilance operations with company SOPs and work instructions
  2. Receipt and oversight of processing of adverse events reported
  3. Case reconciliation of reported cases with internal and external partners
  4. Review of local labeling changes
  5. Provision of appropriate safety-related information in response to external queries
  6. Review of local SDEAs
  7. Training for key personnel, including external partners
  8. Manage the preparation and implementation of local risk mitigation measures
  9. Optimization of local processes managing adverse event reporting
  10. Support the submission of reports to local authorities
  11. Inspection readiness and oversight of deviations/CAPA’s