Maximise product potential, whilst ensuring patient safety
Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of their products.
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.
Our services are both global and European Union (EU) specific for both clinical trials and marketing authorisation holders, as well as manufacturers of medical devices.
Global and European Union Pharmacovigilance
Case Processing and Reporting
Quanticate is able to receive and triage the initial and follow-up of multiple case types including SAEs, AESIs, SUSARs, ICSRs and regulatory coding. We can also support with MedDRA coding within these cases, and the production of narratives. We are able to support with the data entry, medical assessment reporting to competent authorities, ethics committees/institutional review boards and investigators all within validated pharmacovigilance safety databases.
EudraVigilance
Quanticate is able to perform the duties of the responsible person for EudraVigilance for both clinical trial pharmacovigilance or EudraVigilance EU QPPV Trusted Deputy for Marketing Authorisation Holders. By performing this role we 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.
Global Safety Data Management & Database
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 pharmacovigilance safety database and provide you with access to your data. We are flexible in the choice of technologies as we have a range of industry recognised off the shelf technologies available. 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.
Risk Management
Where required, a risk management plan or pharmacovigilance plan is a key mechanism used to document, manage and minimise risk of known and potential safety issues. At Quanticate we support the production of the Risk Management Plan (RMP), its review and also maintenance. This includes implementation of additional pharmacovigilance activities and risk minimisation measures including post-authorisation safety studies (PASS) such as observational studies and registries, creation of targeted questionnaires, and designing and implementing educational materials for risk minimisation. We are also able offer our clients ongoing or periodic assessment of the effectiveness of any RMP and risk minimisation methods in place.
Qualified Person for PV (QPPV)
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. Quanticate can supply an experience 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. Through our PV network, we can also provide local QPPVs/national contact persons for certain EU territories where these are required.
Consultancy, Project Management and SOP Development
With our global team of scientific, medical and quality assurance professionals we are able to provide guidance or support the development update of Standard Operating Procedures (SOPs)/working practices that support PV activities. We also can support the development and delivery of all employee PV training.
Clinical Trial Pharmacovigilance
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 other CROs, multiple sites and investigators and with data safety monitoring board (DSMB) committees.
Clinical Trial PV Services:
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
Study documentation review and update, including protocol and Investigator’s Brochure
Post Authorisation/Marketed Products
For drugs and vaccines that hold a marketing authorisation, it is our objective to support our clients to ensure the risk-benefit profile of these products are monitored in order to optimise the product’s efficacy while ensuring patient safety. We provide pharmacovigilance services that are up to date with regulatory standards, our global 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.
Post Marketing PV 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
Regulatory intelligence for general PV requirements and product specific information
Medical Device Vigilance
Quanticate provide a full range of medical device vigilance (also known as materiovigilance) services in support of both device clinical trials and post-registration requirements. 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.
