Observational Studies
We have experience running observational studies that provide valuable real world evidence to support market access, label expansion, as well as to provide insights into the practical implementation of healthcare interventions.
Post Marketing Safety Studies (PMSS)
It is not only about getting a drug or device on the market; it is also about gathering additional information on their use and performance on a larger scale. Observational studies provide high value information on how your product is used routinely and its real-life safety profile as these insights cannot be obtained from interventional clinical trials. For this reason, post-marketing surveillance studies are an integrated part of the Risk Management Plan of your product as they address questions which can only be detected once the product is on the market.
We have experience running observational studies that provide valuable real world evidence to support market access, label expansion, as well as to provide insights into the practical implementation of healthcare interventions.
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Product Value and Effectiveness in the Real World
Real-life data studies are inescapable in today’s context of increasing demand for added value of new therapies by regulators and payers. Assessing the value and effectiveness of your products is part of their life cycle and risk management if they are to stand out of the crowd.
Observational studies are also particularly suitable when clinical trials cannot be conducted. For instance, pregnancy registries are a very important way of monitoring drug effects in pregnant women and foetuses as expecting women are not involved in clinical trials.
Our strategic consultants deploy creativity and scientific excellence to set up different study designs that meet your specific need. Our approach involves working with experienced epidemiologists who can understand and translate into sound study protocols any question that is related to a product, a disease, a procedure or more broadly an environment. We are experienced in setting up different types of registries, whether disease, product or exposure-based.
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Public Health and Social Science Research
Health systems in most parts of Africa are currently struggling to cope with the unprecedented challenges of the rapidly increasing need for healthcare resources.
It is therefore imperative to find sustainable solutions to strengthen social and health systems with the goal of achieving an improving health in Africa.
Via well-structured interdisciplinary research collaborations, Pharmalys is able to deliver high-quality insights into the behaviour, attitudes and expectations of users and providers of healthcare services that can enable decision-makers to shape the provision of rationalised healthcare services.
We provide health systems research to governments and organisations across the public and charitable sectors to support them in achieving their objectives of improving people’s lives.
We do not simply process questionnaires but work with you to ensure the research meets your objectives, advising on the appropriate methodology, designing your questions and helping you to understand the data.
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