BUSINESS DECISION LIFE SCIENCES

GENERAL DESCRIPTION
Business & Decision Life Sciences is a division of the Business & Decision group, an international consulting and system integration services provider with approximately 2700 employees worldwide. Business & Decision has offices in 19 countries in Europe, North America, Asia, North Africa and the Middle East.
The Life Sciences division is headquartered in Brussels, Belgium. Other offices of Business & Decision Life Sciences are situated in France (Paris), Switzerland (Zürich and Geneva), USA (Philadelphia), Israel (Tel Aviv) and Tunisia (Tunis). Tunisia hosts the offshore facility of Business & Decision Life Sciences. Business & Decision Life Sciences employs around 250 employees across the before-mentioned locations.
Business & Decision Life Sciences (B&D LS) offers a combination of skills, combining expert business process and regulatory knowledge as well as information technologies to leverage Life Sciences companies’ response to an increasingly demanding clinical and regulatory environment.
Our strategy is based on being the best at what we do with the most qualified staff. Our promise to customers is to offer quality, excellence, detailed services on time and on budget. To this end, we are constantly evaluating our work and our staff, adjusting when necessary, and staying at the forefront of new developments.

Market
Pharma and biotech worldwide

Areas of Expertise: mainly biometry in the context of clinical trials, with a specific CDISC experience.
Our CDISC experience ranges from CDISC roadmap consultancy to regulatory submission preparation.
Below is a list of the CDISC services we provide:

• CDISC Data Conversions - For FDA submissions and for data warehousing
• CDISC Compliance Solutions
• Consultancy on CDISC Implementations at the clients’ site:

• Implementation plan/Conversion impact analyses, CDISC Roadmap
• Data standards implementation, e.g: create metadata repository, implement SDTM /CDASH in a data management environment, etc

• CDISC SDTM Trainings

• Private trainings hosted by sponsors and Public trainings hosted by the CDISC organization

SERVICES DESCRIPTION
The company operates three service lines:
Consultancy: the Consultancy services provide specialized expertise and/or additional resources at the sponsor’s site.
CRO: the Contract Research Organization conducts end-to-end clinical studies projects in a regulatory compliant environment.
Service Platforms: the Service Platform model is similar to the consultancy model in that B&D Life Sciences consultants use the client’s SOPs and systems, but work remotely from the B&D Life Sciences offices, providing increased flexibility for the client.

Our offering is as follows:

In Consultancy Mode (B&D LS consultant works at a sponsor’s office): Clinical Trial Management, Data Management, CDISC implementation, Statistical Programming, Biostatistics, Medical Writing, Clinical Datawarehousing, Pharmacovigilance, Health Economics, Data Mining, Bio-Informatics, Clinical Applications, Business Intelligence, Computer Systems Validation.
In Platform Service Mode (B&D LS consultant works for a sponsor at B&D LS offices): Statistical Programming and Biostatistics.
In CRO Project Mode: CDISC Services Clinical Trial Management, Data Management, Statistical Programming, Biostatistics, Medical Writing.

PRODUCTS DESCRIPTION
Data Model Compliance Checker
This tool in conjunction with documented processes and procedures is used to:

• Validate data and metadata on CDISC SDTM V3.1.1 and V3.1.2 compliance
• Provides an easy to use interface for electing and running compliance checks
• Generates comprehensive exception reports
• Generating and validating CDISC compliant data sets can be a lengthy process. Our ata Model Compliance Checker helps resolve this intensively demanding process. The 600+ automated checks help identify and sometimes resolve data issues before the data is sent to the FDA. The tool is user friendly, flexible and has the functionality to import custom data models Innovative aspects This tool “Data Model Compliance Checker” allows to test the CDISC SDTM datasets and define.xml for their CDISC SDTM compliance before sending them to the FDA, resulting in a submission that enhances the use of the FDA reviewer tools and will not fail to load in the WebSDM tool.