Michael Reynolds, APCER Pharma
Outsourced data management in the form of Software as a Service (SaaS) is a partnership needed more than ever—particularly for drug safety, or pharmacovigilance.
Historically, pharmaceutical companies kept their data in-house and went through the traditional and ongoing headaches of software upgrades, database administration, validation and dealing with software vendors.
These activities frequently cause problems, which pull resources away from the primary objective of developing new therapies. Most pharmaceutical companies are dealing with increasing constraints on time, money and resources. Additionally, there is added pressure from the executive level to decrease costs while improving results.
Some of the upcoming regulations will place an even greater strain on pharmaceutical companies’ in-house systems and their maintenance. These include the FDA requiring electronic submission by May 2010, and more countries following the EMEA’s guidance by either encouraging or requiring electronic submission.
The old reasons companies did not implement SaaS no longer apply. Network bandwidth has come of age, and software has been running on the Web for more than 10 years and is usable and practical. User interfaces are also getting better. There is no discernable difference between the performance of an in-house or outsourced system.
Even as pharmaceutical companies expand their operations into Third World or developing countries, there has been no problem with Internet access. Indeed, most of these countries have better Internet and telephone connections than industrialized nations because their infrastructures are brand new and state of the art.
There are numerous pieces to the puzzle that can best be described as the “Pharmacovigilance Continuum.” There are the safety systems themselves, nearly all of which are proven in both large and smaller pharma. There are also newer systems that probably will suffice but are not yet sufficiently tested and therefore present some small risk.
Most of the larger systems have add-ons for the electronic reporting of adverse events. This is a huge advantage because these products will have been tested by specialists—the safety system designers—and the regulatory authorities. They are smart, efficient and have good interfaces with both the system itself and with the authorities’ gateway. There are other pieces to the puzzle but these do not need to be discussed here.
Given that SaaS now is an option for most pharmaceutical companies, it is important to consider what a smaller to mid-size company can do if it doesn’t have a budget for an in-house system.
When considering budget, it is important to remember that it comprises not only the cost of buying a system but also the cost of implementing, running and maintaining it, and the cost of users to input and analyze data.
Companies of this size are ideally suited to an outsourced system and its many advantages. These include mostly fixed and predictable costs, reduced overhead and someone else to manage day-to-day administration. These companies can use the same software as much bigger organizations and have a greater choice of software because many of the providers of outsourced services will give them a choice of the software they want to use.
Generally these software systems are flexible enough to allow input from nil to full access to the system with only data input and the maintenance of the system outsourced. The savings are not only financial; there is peace of mind knowing that the providers have experience and that this is their job. There is the relief of the burden of maintaining another in-house system. And probably greatest of all, there is no need to provide 24-hour support.
A larger pharmaceutical company looking to outsource some of its pharmacovigilance work, on the other hand, could achieve all of the benefits described above without having to waste the time and effort already spent in implementing their in-house system.
Often, the biggest concern of middle management in large pharma is the restriction on headcount. Departments are bursting at the seams, and there is neither the will nor the ability to add more. Outsourcing some of the more arduous or time consuming tasks often is the answer. However, there is also the need to know that these tasks are being performed to the required standard and at the required speed.
As I stated above it should be fairly easy to choose a vendor who runs the same system or has experience of the system in-house. There is no need for in-depth training, just some low-level configuration familiarization.
It is important to reiterate that one of the biggest advantages for any pharmaceutical company is the relief of the burden of maintaining the system. This 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. The time of SaaS definitely is upon us.
Michael Reynolds is head of sales and marketing at APCER Pharma, a global provider of integrated marketing, regulatory and pharmacovigilance services to pharmaceutical companies. Mr. Reynolds has 20 years of experience in the pharmaceutical industry and extensive expertise in regulatory and safety systems and operations. For more information, visit www.apcpharma.co.uk.