There is an advantage in centralizing 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 setup and management of an effective and efficient global pharmacovigilance system, Quanticate provides solutions specific to the requirements of our customer’s organization 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 provide routine and ad hoc outputs for oversight of your safety data. We also utilise our iQ customer portal where data and documents can be easily shared. If you want to outsource any part of the adverse event management process we can help you as needed.
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 have a passion to provide excellence and solutions for the services you require.
Quanticate offer the following pharmacovigilance services:
It is our objective to ensure the risk-benefit profile of products is monitored, in order to maximise product potential, whilst ensuring patient safety. We will support and maintain your quality assured Pharmacovigilance System to regulatory standards.
Quanticate offer the following post-authorisation services:
Quanticate provide a full range of device vigilance services in support of both device clinical studies and post-authorisation needs. Our team of vigilance experts are well versed in the differing requirements for CE-marked and non-CE marked devices, Implantable Medical Devices, In Vitro Diagnostic Medical Devices and drug-device combination products following both EU MEDDEV guidance and FDA 21 CFR 803 and 812 standards.
Quanticate offer the following medical device vigilance services: