Services

Pharmacovigilance

Norwich Clinical Services’ (NCS') pharmacovigilance, product surveillance and drug safety support services cover the entire product life cycle from development, through pre and post-marketing stages. The NCS team is your reliable partner in reaching compliance and maximal effectiveness of your pharmacovigilance/surveillance system and covering the complex regulatory requirements.

Our Pharmacovigilance/surveillance activities are in compliance with the FDA and the latest EU Guidance.

  • Three successful FDA pharmacovigilance inspections (remote from client’s facility)
  • Compliant XEVMPD software
  • Electronic gateway established with EMA, all EU countries and with the FDA
  • Vast experience in data migration
  • Expertise in signal detection for more than 800 molecules
  • Data mining of global safety databases including FDA
  • Literature and regulatory site searches
NCS PV Info
Facts

>900 molecules/products under management

>60,000 cases migrated

SOFTWARE USED
  1. Siemens Open Scape call center solutions for our 24 hour call center
  2. For adverse event reporting 
  3. MedDRA coding
  4. Axway Synchrony for regulatory submission
  5. XEVMPD

Capabilities & Expertise

SAFETY DATABASE

NCS has 21 CFR (part 11) and EudraVigilance compliant pharmacovigilance database for complete adverse event management in the pre and post marketing setting. We undertake database creation and maintenance on behalf of our clients. The database is accessible to our sponsors and EU QPPV located within the EEA.

ADVERSE EVENT PROCESSING

We carry out full service adverse event case processing which includes: case intake/ receipt, triage, data entry, medical coding using latest MedDRA dictionary, safety narrative writing, assessment, follow up activities, CIOMS/ MEDWATCH generation and electronic reporting to regulators. The team at NCS includes highly skilled and trained health care professionals (i.e. physicians, nurses, and pharmacists).

ELECTRONIC SUBMISSION OF CASES TO REGULATORY AGENCIES USING ELECTRONIC GATEWAY

Expedited reporting of cases to EudraVigilance and FDA using electronic gateways. We have also set up electronic gateways with EU countries and FDA.

24/7 CALL CENTER ACTIVITIES: SAFETY & MEDICAL INFORMATION

At NCS we have a team of trained, skillful support specialists. The tasks carried out by this team include the dissemination of accurate, specific, timely and organized medical information in response to the queries by consumers and health care professionals. The tasks of the medical safety team include receiving the adverse events details from consumers and health provider as well as proactively initiating routine follow ups. The adverse events received are processed according to ICSR guidelines. The triaged date is entered into the database along with the respective dates for action and closure.  All follow up attempts and any information collected are recorded.  Monthly reconciliation reports are sent out as per contracted terms.

AGGREGATE SAFETY REPORTS

  1. Periodic Safety Update Reports (PSUR)
  2. Periodic Adverse Drug Experience Report (PADER)
  3. Annual Safety Report
  4. Investigational New Drug (IND) - Annual Report
  5. Developmental Safety Update Report (DSUR)

The generation, quality control, quality assurance, medical review and submission of aggregate safety reports using complaint standardized templates.

SIGNAL DETECTION

Routine and proactive signal detection activities using validated software tools on the PV database by semi-automated methodologies. Manual searches, review and analysis will be carried out by the team of health care professionals and statisticians.

RISK-BENEFIT ANALYSIS

A comprehensive review, analysis and report of risk benefit analysis will be carried out by system specialists.

RISK MANAGEMENT PLAN, RISK MINIMIZATION ACTION PLAN

A comprehensive review, analysis and report generation will be carried out by our health care professionals and statisticians for the following:

  1. Premarketing risk assessment
  2. Development and use of Risk Minimization action plans
  3. Pharmacoepidemiologic assessments
  4. Design pharmacoepidemiological studies
  5. REM strategy

OTHER CLINICAL DOCUMENTS AND PRODUCT LABELS

The generation, quality control, quality assurance, medical review and submission (if needed) of the following clinical documents using ICH complaint standardized template (as required):

  1. Pharmacovigilance System Master File (PSMF)
  2. Investigator brochure
  3. Integrated summary of efficacy
  4. Integrated summary of safety
  5. Clinical safety narratives
  6. Company core data sheet/safety information
  7. Summary of product characteristics
  8. Package inserts
  9. Prescribing information
  10. Patient information leaflet

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