Business & Decision is a global professional services firm that provides eClinical services and solutions to life sciences companies. They have over 2,600 consultants worldwide with deep experience in clinical data management. They offer a full range of implementation, hosting, validation, training, and compliance services for applications like Oracle Clinical, RDC, and TMS. Their validated hosting environment and quality management system help clients meet regulatory requirements for computer systems and infrastructure.

1. eClinical Services and Solutions
Who We Are
Business & Decision is a world class professional services
company that currently employs more than 2,600
consultants worldwide. Founded in 1992, the group has
gained its leadership by leveraging its industry knowledge
and technological expertise to successfully address
today’s most critical challenges for our clients.
Hosting
To meet current FDA and other regulatory requirements,
Business & Decision consultants have been assisting
organizations must demonstrate appropriate control over
companies in the Life Sciences sector for over two
the infrastructure that supports all of their Clinical Data
decades and have been at the forefront of the
Management systems, such as Oracle Clinical, RDC and
development of industry guidance and best practices.
TMS. To help our customers wishing to focus on the their
core business and not the learning curve and overhead
With resources in North America, Europe and Asia, the
associated with regulated hardware, software and IT
Life Sciences eClinical solutions business serves a global
infrastructure, Business & Decision maintains a regularly
client base with a unique blend of business, technical, and
audited, fully qualified data center that offers highly
regulatory experience to help successfully deliver valuable
specialized services.
solutions that support and improve efficiency for Clinical
Data Management.
By accessing your systems from our fully validated and
Implementation Services compliant hosted environment, you will benefit from
systems that are up and running in a short period of time
Business & Decision has experts with the right clinical
as well as low upfront and ongoing costs.
data management experience that can assist your
company with the following services:
By combining attention to detail, security, and support,
We provide initial and upgrade installation and
■
our Data Center located just outside Philadelphia PA,
configuration support for Oracle Clinical, RDC, and TMS
provides a world class IT environment that supports
We will develop an Oracle Clinical Global Library designed
■ mission-critical business services. We provide:
to meet your specific requirements. As recognized CDISC
People: Named primary and secondary support
■
SDTM experts, we can also work with you to design an
personnel who are trained in IT quality procedures,
SDTM compliant library that will eliminate the need for
GAMP and the appropriate regulations, all having a
data conversion at study close out
sense of personal ownership and professional urgency.
We provide initial study design and development in
■
Process: Our policy driven process and procedures
■
Oracle Clinical
feature a world class Quality Management System
We prepare a full set of validation documentation,
■ based on current GAMP, ITIL, and ISO standards as well
provide risk-based testing, develop derivation as our own best practices.
procedures that perform consistency checks against
Infrastructure: We maintain a qualified Tier III
■
your data
environment with guaranteed uptime.
We will install and provide maintenance support of
■
coding dictionaries, including the latest versions of
MedDRA and WHODrug
900 West Valley Road, Suite 900
Wayne, PA 19087-1830
Phone: 610.230.2500
Fax: 610.230.2512
E-mail: info-compliance-na@businessdecision.com
www.businessdecision.com
011008

2. eClinical Services and Solutions
All of our implementation and project management
Validation and Compliance
procedures, tools and templates are reviewed and
Business & Decision offers a full range of validation
approved by our regulatory compliance and computer
services based on proven and widely adapted
systems validation experts to ensure that they are
methodologies and system development lifecycle. Our
suitable for use in the regulated Life Sciences industry.
consultants are published, recognized thought leaders in
the industry and are invited to speak regularly at
Unlike most other validation consultancies, our quality
international seminars and conferences.
management system also includes the procedures, tool
and templates in our Validation Library that are based
To bring your clinical trial and information management
around current, relevant and pragmatic interpretation of
systems, such as Oracle Clinical, RDC, and TMS into full
the latest regulatory and industry guidance – which we
compliance, we offer complete and easy to use validation
also help to develop.
packages that includes, but is not limited to:
Master Validation Plan and Summary Report documents
■
Training
OQ/PQ Plan and Summary Report documents
■
Appropriate training in your clinical data management
User Requirements Specifications
■
applications is an important ingredient in maintaining
A complete set of functional test cases
■
compliant computer systems, and Business & Decision’s
eClinical consultants offer a wide variety of standard
A Traceability Matrix that links each user requirements
■
training to help you train your end users. Our modular
to one or more functional tests
workshop courses are supplemented with extensive live
demonstrations, hands on exercises, and tailored user
In addition, we can support your validation processes with
guides. Standard courses include:
assistance during test execution, vendor audit support,
and reviews or development of departmental standard Basics of Oracle Clinical (5-day)
■
operating procedures.
RDC for Administrators (2-day)
■
Post-implementation, our consultants can help you review RDC for the End User (1-day)
■
systems on a regular basis in order to ensure that they
TMS for Coders (1-day)
■
remain compliant. Periodic reviews of your systems will
TMS for Administrators (2-day)
■
ensure that policies are being followed, changes are
appropriately managed, and risks are correctly assessed Basics of Siebel Clinical (3-day)
■
and handled.
To find out more
Tools and Accelerators For further information on the eClinical services and
Business & Decision has an ISO 9001:2000 registered solutions provided by our Life Sciences division, please
quality management system. Our software development contact Business & Decision using the information below
lifecycle is audited against the ISO 90003 standard and is to identify your nearest representative.
specifically mapped against the GAMP® validation model
(which we helped to develop).
900 West Valley Road, Suite 900
Wayne, PA 19087-1830
Phone: 610.230.2500
Fax: 610.230.2512
E-mail: info-compliance-na@businessdecision.com
www.businessdecision.com
011008