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PHARMACOVIGILANCE

With a team of PV experts including experienced PV physicians, medics and access to our medical writing group, we offer a fully compliant and high-quality complete package of PV services.

Our goal is to help our customers ensure regulatory compliance, along with managing the risk-benefit profile of their products, in order to maximise product potential and ensuring patient safety.

From outsourcing of individual activities to the setup and management of an effective and efficient global PV system, we provide solutions specific to the customer requirements and products.

Following are our globally compliant services for clinical trials and marketing authorization holders.

Clinical Trial Pharmacovigilance

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Clinical Trial Pharmacovigilance

From Phase I to IV clinical trials,

  • We cover drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled.
  • We offer serious adverse effect (SAE) case handling and periodic report production, and we can advance your ongoing safety monitoring so that you can review and manage the evolving safety profile of your product throughout the development process.
  • Our flexibility allows us to work with various stakeholders viz. other CROs, multiple sites and investigators and with data safety monitoring board (DSMB) committees.
  • Medical monitoring and advice
  • Safety database hosting including legacy case migration
  • Development Safety Update Report (DSUR) preparation and submission
  • Global Literature Search & Review in support of the DSUR
  • Investigator meeting PV training
  • Reconciliation of Serious Adverse Events
  • Safety documentation storage and provision in eTMF format
  • Safety documentation storage and provision in eTMF format

Post Authorization / Marketed Products

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Post Authorization / Marketed Products

For drugs and vaccines that hold a marketing authorization, it is our objective to support our clients to ensure the risk-benefit profile of these products are monitored in order to optimize the product’s efficacy while ensuring patient safety.

  • We provide pharmacovigilance services that are up to date with regulatory standards.
  • Our experienced team can support you with flexible solutions to case processing, expedited reporting, periodic safety reports (PBRERs/PSURs and PADERs), global literature screening, signal and risk management activities and support for the European PV framework including QPPV, PSMF and EudraVigilance services.

  • Pharmacovigilance Physician services
  • Preparation and submission of the Periodic Benefit Risk Evaluation Report (PBRER), also referred to as Periodic Safety Update Report (PSUR)
  • Preparation and submission of the US Periodic Adverse Drug Experience Report (PADER)
  • Global Literature Search and Review
  • Local literature review
  • EU Qualified Person for Pharmacovigilance (QPPV) and deputy
  • Pharmacovigilance Awareness Training, Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners
  • Pharmacovigilance System Master File (PSMF) preparation and maintenance
  • Company Core Safety Information (CCSI) production and maintenance

Global and EU Pharmacovigilance Services

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Global and EU Pharmacovigilance Services:

From Phase I to IV, we cover drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled.

We offer serious adverse effect (SAE) case handling and periodic report production, and we can advance your ongoing safety monitoring so that you can review and manage the evolving safety profile of your product throughout the development process.

Our flexibility allows us to work with various stakeholders viz. other CROs, multiple sites and investigators and with data safety monitoring board (DSMB) committees..

  • Recording all conducted training for the purpose of audits, as the training is continuous process.
  • Avoiding non-compliance which affects production quality and causes loss due to inefficiencies.
  • Moving over the Traditional paper-based system used for documenting training.
  • Switching to computerized systems to maintain efficiency as organizations grow in size and geography.
  • Avoiding the inefficiencies due to sheer bulk of the records which may failure of the paper-based system.
  • Failings the system further as paper based system makes audits difficult and tedious.

  • Able to receive and triage the initial and follow up of multiple case types including SAEs, AESIs, SUSARs, ICSRs and regulatory coding.
  • Support with MedDRA coding within these cases and the production of narratives.
  • Support with the data entry, medical assessment reporting to competent authorities, ethics committees/ institutional review boards and investigators all within validated Argus database or other alternative safety databases.

  • Able to perform the duties of the responsible person for EudraVigilance for both clinical trial pharmacovigilance or EudraVigilance EU QPPV Trusted Deputy for Marketing Authorization Holders.
  • Manage all elements of the EudraVigilance process including registration, ongoing management and responsibilities for EudraVigilance submissions, ICSR and MLM downloads, XEVMPD maintenance and EVDAS monitoring.

  • If you would like to have control over your safety data but do not want the cost and delay of setting up a compliant safety processing system, we have an alternative.
  • We can set up and host your PV safety database and provide you with access to your data.
  • We are flexible in the choice of technologies as we have Oracle Argus in place as well as other industry recognized off the shelf alternatives.
  • We provide routine and ad hoc outputs for oversight of your safety data. We are also experienced in supporting PV activities such as case processing for customers with their own database systems.

  • Able to undertake systematic cumulative review of data from all relevant sources to detect and evaluate any potential new signals.
  • Continuous and periodic signal detection and management procedures in place which are written in accordance with ‘GVP: Module IX – Signal management’ and support ongoing safety review of products in both the pre-and post-authorization phase.

  • Where required, a risk management plan or PV plan is a key mechanism used to document, manage and minimize risk of known and potential safety issues.
  • Support the production of the Risk Management Plan (RMP), its review and also maintenance.
  • Includes implementation of additional PV activities and risk minimization measures including post-authorization safety studies (PASS) such as observational studies and registries, creation of targeted questionnaires, and designing and implementing educational materials for risk minimization.
  • Ongoing or periodic assessment of the effectiveness of any RMP and risk minimization methods.

  • Able to provide guidance or support the development update of Standard Operating Procedures (SOPs)/working practices that support PV activities.
  • Support the development and delivery of all employees PV training.

  • Consult an experienced EU QPPV professional to oversee your portfolio which is a cost effective solution to gaining access to the required expertise of QPPV based within the EU.
  • Provide local QPPVs/national contact persons for certain EU territories through our PV network.
  • The EU states that it is a mandatory requirement for a Qualified Person for Pharmacovigilance (QPPV) to be appointed for all approved products in the European Economic Area and who is responsible for ensuring that at the MAHs PV system is compliant with EU requirements.