CDISC Conversions

BDLS is widely recognized as worldwide expert in the conversion of clinical and non-clinical data to the CDISC SDTM, ADaM and SEND standards.

CDISC Implementations

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 .

EudraCT Services

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.

Biometrics Services

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 open communication.

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

Health Economics 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

Data Governance

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.