Pharmacovigilance
Constella’s pharmacovigilance services cover the entire range of clinical trial-related activities, from initial protocol design, through conduct of the trial to study reporting.
It is mandatory that a system is in place for all clinical studies to ensure that serious adverse event and other important safety information is collected and reported to the appropriate individuals and organizations within the required time frames. Constella can undertake all activities required for the management of safety information from clinical trials.
We can provide a comprehensive pharmacovigilance program, or take on some of the following elements, depending on the sponsor company’s requirements.
- Evaluation of safety data
- Management of Serious Adverse Event (SAE) data
- Case treatment code unblinding
- MedDRA coding
- SAE narrative writing
- Electronic reporting of Serious Unexpected Suspected Adverse Reactions (SUSARs) to the EudraVigilance Clinical Trial Module via EVWEB, the web interface for the EudraVigilance Database
- Preparation and submission of IND safety reports
- Reporting of SUSARs to national regulatory authorities and ethics committees
- Preparation and submission of quarterly and annual safety reports
- Writing and updating of Investigator’s Brochures with safety information
- Provision of summaries covering the pre-marketing pharmacovigilance requirements for specified territories
Product Development and Post-Marketing Activities |
Constella provides essential pharmacovigilance services in product development, such as risk management and pharmacovigilance planning. Additionally, our pharmacovigilance service extends into the post-marketing phase of a product’s life cycle.
- Submission of individual case reports to the EudraVigilance Post-Authorization Module via EVWEB
- Periodic Safety Update Reports (PSUR) production
- Preparation for Regulatory Authorities’ pharmacovigilance inspections
Provision of summaries covering the post-marketing pharmacovigilance requirements for specified territories |
Good Pharmacovigilance Practice |
Constella’s experienced team of auditors can guide you through the set up and implementation of a comprehensive pharmacovigilance system. Alternatively, we can review the compliance of your existing system, or those of your contractors, supporting your pharmacovigilance activities through the following services:
- Performance of audits tailored to your particular pharmacovigilance needs throughout all stages of product development
- Assessment of your pharmacovigilance systems and processes, highlighting problem areas and recommending improvements
- Provision of training in EU or US pharmacovigilance regulations and guidelines
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