Pharmacovigilance key to increasing public trust in pharmaceutical industry: SaaS makes software available to all companies
The benefit of pharmacovigilance to the reputation of drug development and marketing concerns is well known. Pharmacovigilance, which underpins government regulations, has become even more important as globalization requires a unified world-wide set of regulations.
Currently, only large companies have their own pharmacovigilance systems. Upcoming regulations, like the FDA’s electronic submission requirement that comes into effect in 2010, will necessitate that small to mid-size companies also use these systems. Most smaller companies do not have the budget to purchase this expensive software application, and to add data-entry employees to their staff, in addition to the personnel needed to implement and maintain the system.
SaaS provides a way for these smaller players to be able to both afford the use of a pharmacovigilance system and to have access to the same software as large corporations. Companies who already have systems can choose to only outsource data input and maintenance. Outsourcing of pharmacovigilance is beneficial to companies for another reason. Michael Reynolds, head of sales and marketing at APCER Pharma, points out that outsourcing pharmacovigilance work “enables the company not only to do its ‘real’ job – bringing new therapies to market – but also to do it efficiently with good, clean, validated data.”
Best-in-Class Clinical Pharmacovigilance Services Providers:
- Ability to perform both contextual single case evaluations as well as case-series analyses
- Performs statistical proportionality and correlation checks
- Has add-ons for the electronic reporting of adverse events
Top Considerations Before Selecting Clinical Pharmacovigilance Services Provider:
If your company already has an in-house pharmacovigilance system, and you are planning on only outsourcing the day-to-day administration, be sure to choose a vendor who runs the same system or has had experience with your type of system. Pick a vendor whose software systems are versatile enough to allow you to have different levels of input from nil to full access as the situation changes.
Key Producers:
1. CLIA-certified Rules-Based Medicine, Inc. (RBM) markets biomarkers for clinical pharmacovigilance testing and other purposes. RBM’s solutions include a self-contained whole-blood culture system for ex vivo immune response measurement and therapeutic-specific MAPs custom designed for late-stage clinical development. RBM's tests, which have been validated to meet or exceed clinical laboratory standards, allow extension of the reproducible biomarker pattern discoveries made in the pre-clinical stage forward into human clinical trial stage. Corporate headquarters and CLIA-certified biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and a subsidiary unit is located in Germany. RBM, founded in 1998, is the world's leading biomarker testing laboratory.
2. The Jackson Laboratory offers state-of-the-art facilities, research support and a wide range of technologies, as well as mice colonies, to organizations around the world engaged in clinical pharmacovigilance studies. This company, which was started in 1929 as one of the first centers for cancer genetics research, is a major provider of genetic resources, software, and expertise to the scientific community. Its extensive experience with experimental genetics enhances the services it offers. This independent, non-profit laboratory has two facilities in Maine and California and plans for a third in Florida, which will be funded by the state. The Jackson Laboratory also advances science by offering academic programs for teachers and students as well as for corporate researchers.
3. Aris Global is a global provider of consultancy services including drug safety, drug safety monitoring, pharmacovigilance, regulatory compliance, medical information and R&D and clinical trials management software. It reports that “more than 300 life sciences companies and CROs in countries around the world use Aris Global’s Total Safety — a comprehensive suite of integrated software solutions that enable life science organizations, regardless of status or size, to implement effective domestic and global pharmacovigilance, clinical safety, Signal detection and risk management programs.” This Stamford, Connecticut-headquartered company was founded in 1987.
4. BioSoteria provides a broad range of pharmacovigilance solutions and individually tailored services to the biopharmaceutical industry. Safety services range from an a la carte safety solution to serving as a fully functional safety department. It also has drug safety training and educational programs. BioSoteria reports that its management team "has experience building drug safety departments from the ground up at start-up companies and expanding pharmacovigilance capabilities for larger companies." This company has decades of experience and has offices in California and North Carolina.
Clinical Pharmacovigilance Services
Definition: Pharmacovigilance (PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of the adverse long and short term side
