With a team of PV experts including experienced PV physicians, medics and access to our medical writing group, we offer a fully compliant and high-quality complete package of PV services.
Our goal is to help our customers ensure regulatory compliance, along with managing the risk-benefit profile of their products, in order to maximise product potential and ensure patient safety.
From outsourcing of individual activities to the setup and management of an effective and efficient global PV system, we provide solutions specific to the customer requirements and products.
Following are our globally compliant services for clinical trials and marketing authorization holders.
From Phase I to IV clinical trials,
For drugs and vaccines that hold a marketing authorization, it is our objective to support our clients to ensure the risk-benefit profile of these products are monitored in order to optimize the product’s efficacy while ensuring patient safety.
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 various stakeholders viz. other CROs, multiple sites and investigators and with data safety monitoring board (DSMB) committees.
