Pharmacovigilance Expertise at Client Associated Businesses, Inc. Complements CAB’s Expertise in Clinical Data Management, and Database Development and Programming.
As we launch the redesign of our Bio-Investigations Ltd. website in January 2014, we will initiate postings in this section on various topics. As our first entry of this redesigned website and for the New Year we are looking back to companies to whom we have provided services over the past 26 years, to highlight a company and a principal individual. We have chosen Paul Bellenoit as the individual, and Client Associated Businesses, Inc. (CAB), the company he co-founded, headquartered in Niantic, CT, USA.
We first met Paul Bellenoit in 1998 when he worked for Kendle International, Inc. Paul’s knowledge of the contract research organization (CRO) industry was impressive and evident from our first meeting. With Bio-Investigations Ltd. focused in the commercialization of pharmaceutical and biomedical innovative technology from inception through the approval of diagnostic and therapeutic candidates, identifying those individuals and organizations that had a pulse in the CRO industry was paramount. Paul’s character, professionalism, and knowledge of the industry allowed him to co-found Client Associated Businesses, Inc., now in operation for over 13 years. Client Associated Businesses, Inc. has differentiated itself by having the experience and flexibility to provide a low cost alternative to companies needing data management services, with a particular focus in Oracle Clinical based services.
What we find attractive about Client Associated Businesses, Inc. and high in the value proposition model is that the company has the expertise and experience to service large multinational companies such as present clients including Pfizer and Novartis, but also has the personal approach to provide individualized services to smaller companies, with services always targeted to the needs of individual clients. The very personal approach utilized by Bio-Investigations Ltd. in providing its services has been accomplished at a much higher level, in their industry segment, by Client Associated Businesses, Inc. This parallel in focus on “customer” or client service that CAB has as part of its core mission is unique, and appropriate for our coverage of them in this communication.
Unlike a traditional CRO, CAB operates in what is referred to as a Functional Service Provider (FSP) model, where they provide a variety of remote based data management services, tailored to a client’s specific need. This model has proven highly effective for those companies seeking to augment their internal staff or develop a team of specialized resources that can be structured to meet a specific staffing need. Flexible with the capacity to be tailored to provide support for a specific function or multiple functions on a short or long term basis, CAB’s headquarters in the United States, along with an operational unit in Delhi India, has an international appeal.
CAB is positioned in 2014 to continue providing biometric support to the pharmaceutical, biotechnology, and medical device industries, as well as other organizations including, but not limited to, CROs. What will continue to be a differentiating factor of CAB, in our opinion, is that their team of highly experienced data managers, database programmers, pharmacovigilance managers and IT technical consultants will continue to provide custom tailored resourcing and production support within adaptable models to meet a clients specific staffing needs.
Specializing for many years in Oracle Clinical™ systems support and operating in a Functional Service Provider model (FSP), CAB can provide production staffing solutions in any or all of the following areas:
• Database Development and Programming
• Data Management
• Data Entry, Scanning and Indexing
• Data Management QC
• Pharmacovigilance Case Processing and Hosting
• Oracle Clinical, Argus and IT Technical Consulting
Looking at the industry and looking forward to 2014, we believe that Pharmacovigilance Case Processing and Hosting will become the most important growth sector within the CRO industry, and that CAB’s commitment to — and expertise within — this area will continue allowing for CAB to excel. With this in mind we share CAB’s services in this one selected area:
AE CASE MANAGEMENT SERVICES:
• Processing of individual Case Safety Reports (ICSRs) originating from various sources
• Post-marketing non-solicited reports/Spontaneous reports
• Clinical trial reports
• Special reports (Legal, Literature and E2B)
• Triage and tracking all cases
• Initial and final regulatory assessments
• MedDRA and WHO-drug coding
• Medical narrative
• Development and maintenance of Analysis of Similar Events
• Complete medical monitoring and follow-up support
• Processing of expedited ICSRs to regulatory authorities
REPORTING SERVICES:
Periodic Post-marketing safety reports:
• PSUR (6 months, annual or 3-year in accordance with Volume 9A, GVP, Schedule Y)
• Summary Bridging Report Addendum
• PADER (annual or quarter reports in accordance with 21CFR 314.80 (c) 2)
Periodic clinical trials related safety reports:
• ASR/DSUR
• Semi-SUSAR Ad hoc safety reports
• Clinical Overview for labeling update
• Safety expert report for assessment of safety queries
Other reports:
• Safety summary
• Customized line listings for aggregate data
LITERATURE SCREENING SERVICES:
• Specialists with vast subject matter expertise and domain centric knowledge
• Extensive worldwide literature search in peer-review journal databases and medical databases
• Knowledge and adherence to global regulatory requirements and compliance
• Review of articles/ abstracts for inclusion in ICSR, PSURs and other specialized reports
We will be following Client Associated Businesses, Inc. as the health care industry continues to change. With the advancement of new models to further expedite the FDA approval of pharmaceutical and biomedical drug and diagnostic candidates, as well as medical devices, we believe that Client Associated Businesses, Inc. will continue to position itself to provide quality services, at affordable prices. Paul Bellenoit, along with the entire team at Client Associated Businesses. Inc., deserve enormous credit for their contributions to the health care industry.
If you would like to learn more about the services CAB can provide further information is available at their website, at www.clincab.com.