PHARMACOVIGILANCE

Pharmacoepidemiology and Risk Management Solutions

 

Consulting

Our researchers bring hundreds of years of experience from industry, regulatory authorities, and academia in all important therapeutic areas, as well as advanced degrees in medicine, pharmacoepidemiology, biostatistics, pharmacology, and public health to the table to provide expert advice on all areas of pharmacovigilance risk management and pharmacoepidemiology.

Risk and Benefit-Risk Analyses (qualitative and quantitative)

We have significant industry experience in setting up and performing different types of risk analysis.

Lifecycle Risk Management Planning (RMP)

Risk management planning has to be a lifecycle activity, commencing well before entry into man and finishing only after the product is not on the market anymore.

Design, implementation and evaluation of effectiveness of additional Risk Minimisation measures (aRMMs)

Our experts have been developing and implementing aRMMs for products from various disease areas according to the requirements of the EU PV legislation, as part of REMSs, and for global risk minimization approaches.

Advanced Signal Management

We have industry experience in creating efficient, compliant, multidisciplinary processes for signal detection and management, including the appropriate use of up to date statistical methodologies and data mining approaches within product safety risk management systems.

Post-authorization safety and efficacy studies (PASS/PAES)

We have been contributing to the development and execution of PASS/PAES for several products from various therapeutic areas as part of the PV activities required for products in Europe, following PRAC referrals.

Prospective observational research, Registries

We support clients in the design and implementation of prospective observational research approaches, including cohort studies, patient registries, and surveys of patients or HCPs, as part of risk management programs or plans.

Systematic Literature reviews and metaanalysis

Our data analysis experts offer systematic literature reviews at various levels of complexity according to your requirements.

Issue and Crisis Management

When risk management fails, issues and sometimes crises develop.