PHARMACOVIGILANCE & CLINICAL SAFETY
3B Biotech offers a range of local and global high-quality pharmacovigilance services. Through our sister company GB Pharma we provide efficient solutions, comprehensive of the Role of EU-QPPV, to also maintain your PV system in Europe
A comprehensive and customized package of local & global pharmacovigilance services to ensure the patient safety at any stage of the product life-cycle, from early clinical development to marketed product support.
Pharmacovigilance Services
With a set of procedures and a qualified Pharmacovigilance staff, we provide the fulfillment of key PV functions, including the QPPV role on behalf of your Organization to follow these tasks:
PV System management – Main point of contact for Cas, EMA and Inspection (24/7 availability) – Oversee the safety profile of your portfolio – Assessment of the benefit-risk balance – Review and approval of PASS – Management of Risk minimisation measures
Our Risk Management experts may help you drafting, reviewing and submit an RMP classifying important, identified and potential risks. Additionally, we help our Clients in establishing appropriate RMMs to maximise the use of your products and increase the safety of your products.
3b Biotech takes care of all aspects of Eudravigilance registration and maintenance, providing you qualified and trained users to manage all modules embedded within the European database.
From PSURs to signal detection, including RMPs, our service includes plamnning, drafting, reviewing and submission of aggregrate reports. An ongoing overview of the benefit/risk balance as well as of the efficacy and safety of the products is assured by our skilled technicians and medical experts.
Our literature screening service is based on systematic worldwide reference database.
The high number of active substances currently monitored allow us to be highly competitive on the service.
We can support you in planning Signal Detection activities and undertake the cumulative review of safety data.
With an effective process and a medical team in place, we can support you with Signal Management with both spot or full services.
The management of third Parties of your Organization, including commercial partners and vendors, is key to your PV System. Since the implementation of PV Technical and Safety Exchange Agreements, our support includes the compliance check and monitoring of your partners and the implementation risk assessment strategy.
Through a high performance of ICSRs submission and exchange, our solutions allow us to operate on your database by remotely entering and processing safety data or provide you with our validated Safety Database.
Compliant pharmacovigilance procedures during your pre- and post- marketing clinical trials are key to your product success.
Through our Clinical Department and Clinical trial safety officers we ensure pharmacovigilance information of clinical trials is timely and properly managed, We support your Organization to manage SDEA, SAEs, SUSAR and DSUR, as well as regulatory submission/notification to stakeholders.
We provide a full range of services for both device clinical studies and post-registration needs.
Our team of vigilance experts are well versed in the differing requirements for CE-marked and non-CE marked devices, Implantable Medical Devices and drug-device combination products
The processing of the case in the security database will be performed by applying Data Entry, Quality Control and Medical Evaluation;
3B Biotech will be responsible for the management of ELVIS PORTAL on behalf of its clients.
Our PV Network
3B Biotech Research is your provider for global and local pharmacovigilance services. We can offer tailored local Pharmacovigilance services through a network of local providers highly skilled and experienced on Pharmacovigilance topics. Our trusted partners are mid-size Companies that we have been selected and qualified over the years.
Through this network we ensure our Clients with:
- High compliance with local pharmacovigilance requirements;
- Timely and efficient exchange of safety information;
- High quality of translation activities;
- A comprehensive list of non-indexed local scientific journals;
- Qualified staff to act as local contact or responsible person for Pharmacovigilance;
- A global and tailored PV System.