Our services
- Epidemiological & statistical consulting services
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- Database studies; methodological expertise
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- Regulatory Post-authorisation Safety Studies “PASS”
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- Evidence synthesis
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- Evidence strategy: pre-clinical to post-marketing
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- Data resource evaluation
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- Design and analysis of registries
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- Benefit-risk modeling
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- Drug uptake monitoring
Everyone at epifocus is dedicated to providing you with an elite service.
Here are some of the services we provide at epifocus.
We also provide a lot more services that aren't listed. You can find out more by contacting us.
we also provide:
Chart reviews:
design, management, analysis,
writing
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Prospective studies :
design, management, analysis,
writing
more information.
a small insight into what we do at epifocus.
1
Primary data analytics
At epifocus, we will:
Design the study, write the protocol, create a statistical analysis plan and table shells, provide data management services,
data analyses, and all medical writing.
We work closely with our partners who undertake data collection
(as well as site contacting, and contracting) and design the eCRF and other study documents.
epifocus partners with trusted companies that perform data collection.
We are currently undertaking a multi-country study on advanced breast cancer
2
Secondary data analytics
epifocus analyses pre-existing data when needed to come to a conclusion.
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The analysis of pre-collected medical data is an efficient way to undertake bespoke drug
& epidemiological research.
Care and experience are needed as the data are normally for clinical management
and hence understanding data quality is vital.
Andrew Maguire, director of epifocus developed the main data quality parameter for the THIN database.
3
Disease registers and how we use them
If your study requires the use of pre-collected data that is specific to a disease area, using
existing registries may be a good option.
For example, epifocus would work together with
BCB medical who have access to nearly 100 diseases registries in
Nordic countries and who have experience in creating bepsoke cohorts using available linked
national patient registries.
databases
we work
with:
epifocus work with a number of different databases.
Here are some of the databases we work with below:
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CPRD, THIN UK, THIN FRANCE, UK HES (Hospital Episode Statistics)
CEGEDIM
and
THIN®
Cegedim Health Data own and manage THIN® (The Health Improvement Network), a suite of primary
care databases.
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Holding a copy of the THIN database (UK), we work with Cegedim directly. We undertake analyses of THIN and
provide input to undertake ongoing evaluations.
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We provide epidemiological and statistical support to Cegedim where needed.
An example of this is in the
analyses and subsequent publication on fixed triple therapy to treat COPD in France, then cited by:
HAS (Haute Autorité de Santé) to modify the recommendation on prescribing Haute Autorité de Santé - TRIXEO AEROSPHERE (formoterol/glycopyrronium/budesonide) - COPD (has-sante.fr)
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https://www.has-sante.fr/jcms/p_3242546/en/trixeo-aerosphere-formoterol/-glycopyrronium/-budesonide
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post authorisation
safety studies. (PASS)
These studies are required by the European Medicines Agency “EMA” to ensure that safety concerns
for newly approved treatment are adequately monitored.
Such studies are usually long-term safety
studies (prospective cohort studies) or may measure the impact of additional risk minimisation
measures.
Additional information can be found below:
epifocus is currently undertaking 3 PASS in rheumatoid arthritis and growth hormone deficiency. We
work with disease and treatment registries in Europe and also conduct analyses using secondary
data resources.