BUSINESS & DECISION LIFE SCIENCES more than just a croAll the tools you need to build, report and maintain your clinical data.
Decision Life Sciences (BDLS) is a specialized high-tech CRO and
Resourcing company, taking advantage of Digital technologies to optimize
collection, transformation and usage of Life Science data by adapting
to new industry evolution and regulations
BDLS is widely recognized
as worldwide expert in the conversion of clinical and non-clinical data
to the CDISC SDTM, ADaM and SEND standards.
BDLS provides expert solutions and services to implement, manage and maintain CDISC
standards and associated workflows and processes, moreover BDLS can
help you managing the oversight of the CRO’s you are working with,
ensuring CDISC compliant trials.
Data Standards Library
Upfront implementation of
the CDISC standards and processes into a biometrics system can
significantly improve study delivery timelines and quality. BDLS
develops and maintains your platform independent Data Standards Library and your Metadata Repository
that enables you to automate the exchange of specifications and
instructions to your internal and external partners. Using such a
Standards Library from study set-up to submission increases consistency
across compounds and cost efficiency
Industry leading solution for De-identification of clinical trial data
With the growing need for
data transparency (Policy 0070), it is critical to ensure that patient
privacy is maintained without limiting the usability of the data. BDLS’s
experienced team understands the appropriate and planned use of the
data, the rarity of the disease under study and the study design. BDLS
uses the principle of 7 PhUSE de-identification methods across the
clinical trial data. The process consists of three steps:
-Assessing the role of each variable in term of identification potential, quasi and direct identifiers across the datasets
-Primary & Alternative Rules for De-Identification are assigned
-Understanding rationale and address exceptions and special considerations
This in turn leads to
important, sometimes very subtle, differences between clinical trials.
BDLS has been working with 2 of the world’s top 10 pharma companies and has launched the De-I.D. solution for de-identifying clinical trials .
BDLS provides expert services for posting the Clinical Trial Summary results into the EudraCT system.
Since 21 July 2014, it is
mandatory for sponsors to post clinical trial results in the European
Clinical Trials Database (EudraCT), managed by the European Medicines
Agency (EMA). BDLS offers a fast and flexible solution to ensure
compliance within the defined timelines. Over the past years, an expert
team has developed a standardized and partly automated routine to
deliver this high quality service.
We are a specialist biometrics company. Our bespoke data management, biostatistics, medical writing and consulting services deliver pragmatic solutions that are flexible, adaptable and generate high-value for our clients.
Our customer focus ensures
you work with the best biometricians and your project is always treated
with the highest priority. We establish strong, collaborative and
proactive relationships with our clients, built on trust, honesty and
RWE & Big Data
RWE: Unleashing the information of real world data
Real World evidence
is taking utmost importance in nowadays healthcare. Using patient-level
data allows to better understand treatment practice, treatment patterns,
compliance, safety, long-term outcomes, and comparisons going beyond
the RCT data. It is of critical interest for regulators, payers and the
pharmaceutical industry (R&D, medical affairs, market access, and
safety. Business & Decision Life Sciences positions itself as a key
partner in providing integrated services. Our services include
trainings, business question formulation, data landscaping, high-end
computing and dynamic / real time deliverables in line with the most
recent technological, methodological and regulatory standards.
Epidemiology: Beyond incidence and prevalence
Modern Epidemiology and pharmacoepidemiology
are the cornerstones of healthcare research. Our offer goes way behind
incidences and prevalences and include healthcare use, unmet needs,
morbidity, mortality and health economics. Business & Decision Life
Sciences offers access to virtually any existing data on diseases,
treatments, their treatments and their potential side effects. We also
collaborate with major data providers to generate innovative quality
solutions when information is scarce.
Health Economics: Determining the value of innovation in healthcare
have evolved considerably over time. Business & Decision Life
Sciences combines a network of experts in this field and
state-of-the-art technology allowing for accurate modelling of any
healthcare intervention. Our offer includes Markov and Monte-Carlo
simulations, impact models, budget optimization, outcome-based pricing,
multi criteria decision analysis, support to HTA and pricing &
reimbursement submissions as well as corresponding trainings.
Data Visualization in Life Sciences
Business & Decision
Life Sciences is promoting "DataViz" solutions, characterized by speed
of deployment, simplicity (business users are able to produce Dashboard
without IT support) and quality of the information delivered to the
end-users. The DataViz solutions are based on new technologies
("in-memory" engine), like Tableau, QlikSense, Spotfire or SAS Visual
Analytics. The strengths of the tool rely on the short learning curve
for the business users, quickly able to produce their own dashboard
through intuitive and advanced visualizations objects
Amongst the many challenges
that the healthcare industry faces, complexities in study design and
data collection are extending the time taken to prepare clinical data
for regulatory submissions. This will increase the cost for sponsor
companies and there is also the risk that data is misinterpreted either
during submission preparation or by the regulatory agencies. The
standardization of clinical data helps companies understand their
clinical data effectively and is helping regulatory agencies streamline
their review times.
The implementation of CDISC
Data Standards within an organization can be a complex operation as
many stakeholders need to be consulted and operational procedures
considered. When the implementation is complete, reductions in
submission time, savings in resource costs as well as increases in
quality will happen immediately.
As with any asset of the organization, the definition of effective governance is necessary to obtain maximum value.
To answer this matter, BDLS
has created a strong expertise & various accelerators in the Data
Governance landscape, based on a range of tools and process to plan,
supervise and control over data management and its use.