Our services
Below are a selection of services provided at epifocus.
Contact us for other services not listed.
01
Epidemiological & statistical consulting services
02
Database studies; methodological expertise
03
Regulatory Post-authorisation Safety Studies “PASS”
04
Evidence strategy: pre-clinical to post-marketing
05
Data resource evaluation
06
Design and analysis of registries
07
Benefit-risk modelling
08
Drug uptake monitoring
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 trusted partners who undertake data collection
(as well as site contacting and contracting) and design the eCRF and other study documents.
We are currently undertaking a multi-country study on advanced breast cancer.
2
Secondary data analytics
The analysis of pre-collected medical data is an efficient way to undertake bespoke drug utilisation
& epidemiological research.
epifocus has over 50 years of combined experience in analysing data from a range of
sources.
Andrew Maguire, director of epifocus developed the main data quality parameter for the THIN® database.
3
Regulatory and Safety Consultancy
New drugs typically require a commitment to Post-Authorisation Safety Studies (PASS) to assess
long-term safety and the effectiveness of risk minimisation measures. Leveraging our experience, we
offer end-to-end support throughout the PASS process.
In addition, we undertake PASS analyses, using appropriate data resources, again including
protocol and SAP development, analyses and report writing and input for regulatory submission.
databases
we work
with:
epifocus works with a number of different databases.
Here are some of the databases we work with:​
​
CPRD, THIN UK, THIN FRANCE and
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.
​
Holding a copy of the THIN® database (UK), we work with Cegedim directly. We undertake analyses of THIN®and
provide input to ongoing evaluations. of THIN®data.
​​
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 - TRIXEO AEROSPHERE (formoterol/glycopyrronium/budesonide) - COPD (has-sante.fr)
​
https://www.has-sante.fr/jcms/p_3242546/en/trixeo-aerosphere-formoterol/-glycopyrronium/-budesonide
​
post authorisation
safety studies. (PASS)
These studies are required by the European Medicines Agency “EMA” to ensure that safety concerns
for newly approved treatments 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 PASSs in rheumatoid arthritis and growth hormone deficiency.
We work with disease and treatment registries in Europe and also conduct analyses using secondary data resources.