Implementation Services
Business & Decision has experts with the right clinical data management experience that can assist your company with the following services:
- We provide initial and upgrade installation and configuration support for Oracle Clinical, RDC, and TMS
- We will develop an Oracle Clinical Global Library designed to meet your specific requirements. As recognized CDISC SDTM experts, we can also work with you to design an SDTM compliant library that will eliminate the need for data conversion at study close out
- We provide initial study design and development in Oracle Clinical ■ We prepare a full set of validation documentation, provide risk-based testing, develop derivation procedures that perform consistency checks against your data
- We will install and provide maintenance support of coding dictionaries, including the latest versions of MedDRA and WHODrug
Hosting
To meet current FDA and other regulatory requirements, organizations must demonstrate appropriate control over the infrastructure that supports all of their Clinical Data Management systems, such as Oracle Clinical, RDC and TMS. To help our customers wishing to focus on the their core business and not the learning curve and overhead associated with regulated hardware, software and IT infrastructure, Business & Decision maintains a regularly audited, fully qualified data center that offers highly specialized services.
By accessing your systems from our fully validated and compliant hosted environment, you will benefit from systems that are up and running in a short period of time as well as low upfront and ongoing costs.
By combining attention to detail, security, and support, our Data Center located just outside Philadelphia PA, provides a world class IT environment that supports mission-critical business services. We provide:
- People: Named primary and secondary support personnel who are trained in IT quality procedures, GAMP and the appropriate regulations, all having a sense of personal ownership and professional urgency.
- Process: Our policy driven process and procedures feature a world class Quality Management System based on current GAMP, ITIL, and ISO standards as well as our own best practices.
- Infrastructure: We maintain a qualified Tier III environment with guaranteed uptime.
Validation and Compliance
Business & Decision offers a full range of validation services based on proven and widely adapted methodologies and system development lifecycle. Our consultants are published, recognized thought leaders in the industry and are invited to speak regularly at international seminars and conferences.
To bring your clinical trial and information management systems, such as Oracle Clinical, RDC, and TMS into full compliance, we offer complete and easy to use validation packages that includes, but is not limited to:
- Master Validation Plan and Summary Report documents
- OQ/PQ Plan and Summary Report documents
- User Requirements Specifications
- A complete set of functional test cases
- A Traceability Matrix that links each user requirements to one or more functional tests
In addition, we can support your validation processes with assistance during test execution, vendor audit support, and reviews or development of departmental standard operating procedures.
Post-implementation, our consultants can help you review systems on a regular basis in order to ensure that they remain compliant. Periodic reviews of your systems will ensure that policies are being followed, changes are appropriately managed, and risks are correctly assessed and handled.
Tools and Accelerators
Business & Decision has an ISO 9001:2000 registered quality management systems. Our software development lifecycle is audited against the ISO 90003 standard and is specifically mapped against the GAMP® validation model (which we helped to develop).
All of our implementation and project management procedures, tools and templates are reviewed and approved by our regulatory compliance and computer systems validation experts to ensure that they are suitable for use in the regulated Life Sciences industry.
Unlike most other validation consultancies, our quality management system also includes the procedures, tool and templates in our Validation Library that are based around current, relevant and pragmatic interpretation of the latest regulatory and industry guidance – which we also help to develop.
Training
Appropriate training in your clinical data management applications is an important ingredient in maintaining compliant computer systems, and Business & Decision’s eClinical consultants offer a wide variety of standard training to help you train your end users. Our modular workshop courses are supplemented with extensive live demonstrations, hands on exercises, and tailored user guides. Standard courses include:
- Basics of Oracle Clinical (5-day)
- RDC for Administrators (2-day)
- RDC for the End User (1-day)
- TMS for Coders (1-day)
- TMS for Administrators (2-day)
- Basics of Siebel Clinical (3-day)
To find out more
For further information on the eClinical services and solutions provided by our Life Sciences division, please contact Business & Decision using the information below to identify your nearest representative.
eClinical Services and Solutions, Implementation Services, Hosting, Validation and Compliance, Training
