Safety & Pharmacovigilance Services

Protheragen has designed its safety & pharmacovigilance services to invoke drug safety management with a pragmatic and holistic touch. We possess advanced infrastructure that enables us to cover the global landscape, which greatly facilitates the multipronged nature of pharmacovigilance while placing the core focus on patient safety and aiding in the proper crafting through post-marketing surveillance of drugs.

Introduction to Safety & Pharmacovigilance

Pharmacovigilance (PV) is an important branch of pharmaceutical science that concerns the "collection, detection, assessment, monitoring, and prevention" of destructive side effects of drug products. The term is composed of two pieces, 'pharmakon' which means drug in Greek, and 'vigilare' meaning to watch in Latin. This branch deals with adverse drug reactions primarily which include noxious responses to a drug and at times lack of efficacy. However, the domain of PV has widened over the years to also cover ADR-less incidents like overdose, misuse, abuse, and drug use during pregnancy and breastfeeding, as they may lead to ADRs.

Fig.1 Timeline of the historical evolution of Pharmacovigilance. (Fornasier G., et al., 2018)

Safety & Pharmacovigilance in Clinical Research

Pharmacovigilance is crucial for the drug during its clinical phases and in post-market assessment as well:

• Clinical Trials: Pharmacovigilance experts ensure the safety and efficacy of the trial participants and more importantly, ensure the regulatory requirements are met throughout the duration of the trial by monitoring adverse and serious adverse events alongside other safety measures.
• Post-Marketing Surveillance: Everyone involved with a manufactured product markets it and thereafter undergoes post-marketing surveillance which includes but is not limited to adverse event reporting, signal strategies, and analyzing extensive data.
• Global Compliance: In an effort to comply globally during the pharmacovigilance process there are specific local regulations to be adhered to, there are international regulatory bodies like the EMA, FDA, and WHO among others that have to be complied with.

Our Services

Protheragen offers a comprehensive suite of pharmacovigilance services to support clients throughout the drug development lifecycle and beyond.

Our experts bring deep knowledge and experience in various therapeutic areas, enabling us to provide tailored solutions that address the unique safety challenges of each drug class. If you are interested in our services, please feel free to contact us.