IT services/Database management Services
In house Safety Database Management
Our tailored database solutions which are designed to meet the unique requirements of our clients. With proficiency in major global pharmacovigilance databases such as ARIS Global and ARGUS, our team is adept at providing comprehensive support. Whether clients are transitioning between databases or initiating a new one, our skilled IT and operational teams guide the process from database validation to seamless data migration.
Additionally, we offer an in-house E2B validated database that can be deployed either on the cloud or on-site, catering to clients with compliance objectives on a more constrained budget.
Clini Resource excels in utilizing EudraVigilance Webtrader for the submission and receipt of Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). Our IT team is well-versed in electronic gateway submissions to global health authorities, where electronic submission capabilities exist. We are also proficient in submitting and retrieving medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), ensuring adherence to controlled vocabulary standards for marketing authorization of medicinal products.
Remote Data Entry
We at Clini Resource also offers remote data entry into a range of Pharmacovigilance Databasesfor our client by experienced resourcestemporarily or regular, based on the client need. This helps client to meet their immediate need.
We also offer resource base database services where only Quality check or Medical review of client sight entered cases can be done by senior physicians who understand well the regulatory expectation of ICSR. This can be managed by remote access to the specific database workflow.
Electronic Document Management System
Under development by the IT team.
Huge volume of data transfer is always a challenge while shifting from one database to another.
Our IT team at Clini Resource work closely with the client to understand their need and propose the best solution and take care the complete data migration process to ensure the complete data transfer from one technical platform to another technical platform.
IT Support Services
Our IT team can offer you cost effective routine support of your pharmacovigilance database, server support, and help in other day to day simple technical assistance.
Veterinary pharmacovigilance Services
Veterinary pharmacovigilance as a service is mostly uncharted territory in most places of the world. But this becomes especially tricky since veterinary products may have untoward effects both in the intended recipients of the products, i.e., animals, as also in the unintended recipients or humans. Adverse reactions may occur in humans in conjunction with the treatment of an animal, or through the handling of a veterinary medicinal product, or following exposure to a veterinary product through the environment. In all these cases, regulators demand additional data on both the animal and the human. And since the use of these products is limited, therefore exposure data also becomes limited.
Our team of experts are well versed with the international guidelines on veterinary pharmacovigilance, and various special situations where human pharmacovigilance differs from veterinary pharmacovigilance.