Pharmacovigilance Services
There is advantage in centralising all safety data, clinical data, analysis and reporting with one provider. By combining Quanticate’s substantial biometrics, medical writing and pharmacovigilance expertise, we offer a fully compliant and high quality complete package of pharmacovigilance services. Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximise product potential, whilst ensuring patient safety. From outsourcing of individual activities, to the set-up and management of an effective and efficient global pharmacovigilance system, Quanticate provides solutions specific to the requirements of our customer’s organisation and products.
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, Quanticate has an alternative. We can set up and host your safety database and write your SOPs. We have Oracle Argus in place and you can obtain web access so that you can enter, process and view reports on your data. If you want to outsource any part of the adverse event management process we can help you as needed.
Pharmacovigilance services include:
- Adverse Event Case Processing
- Expedited Case Reporting
- EudraVigilance & Electronic Reporting
- Safety Data Management & Global Safety Database
- Signal Detection & Evaluation
- Pharmacovigilance Report Preparation & Submission
- Literature Search & Review
- EU Qualified Person for Pharmacovigilance
- Medical Monitoring
- Pharmacovigilance Quality Assurance
