Does cloud CTMS hosting offer a real advantage over on-site solutions? With increasing market pressure and ever tightening budgets, clinical research organizations of every size are being driven to find new ways to efficiently manage clinical trial data. But with patient health and business success at risk, data security and regulatory compliance have to stay at the forefront.
Looking at some of the primary decision points, there are real benefits to a cloud-based solution – but only if the hosting provider meets stringent regulatory requirements.
Cost and Speed
Time and money are often the main drivers for move toward cloud CTMS hosting. The savings in infrastructure costs with a cloud solution are readily apparent, but the deployment and maintenance costs are where you'll see the most immediate difference.
Even if you already have top notch IT and computer systems validation teams in house, it can take up to a year or more for them to spec, install and validate all of the software and hardware for your CTMS. Once the system goes live, the costs of maintaining the system will continue as the teams monitor and upgrade the system and carry out required periodic re-qualifications. But with a qualified CTMS hosting provider, you can be up and running in a fraction of the time.
How does a company offering cloud CTMS solutions save so much time? It it because they cut corners or have some unknown engineering skill that lets them do everything an in house team must do, but in a fraction of the time? The answer is that they will do all of the same tasks that would be required of your team, but that they are able to do it more quickly for you because they've already executed most of the process before you even entered the scene.
With compliant cloud CTMS hosting, you are walking in to a fully qualified system.
A hosting provider's reputation rests on their security systems, and they will have a full time technical staff focused on protecting customers' data. If you've chosen the right partner, a cloud-based CTMS will have several layers of security and protection for your data, including physical security, firewalls, backup and intrusion detection.
With an on site solution, it can be difficult for an IT team to stay on top of required upgrades and keep the system secure and in a validated state. Managing and controlling client upgrades may be next to impossible. By employing a cloud CTMS solution, this is all managed by your provider. What's more, they can typically qualify the changes before they reach you, so your team won't suffer any downtime.
Compliance concerns are the main reason a clinical research organization may be reluctant to adopt cloud-based solution. With so much at stake, the risks of running afoul of the regulations may seem to outweigh the cost benefits.
With a strong, proven CTMS hosting provider, you can actually enjoy better assurance of regulatory compliance than with an on-site system. If your hosting partner's mission is to provide compliant IT solutions, they will likely be better at supplying everything the agencies require than your in-house staff. While your business' focus is on developing life-saving products, theirs is solely on providing robust IT solutions that can withstand any audit.
They'll have a validated data center. They'll have a mature quality system, and a rigorous training process. They'll have strong documentation packages to demonstrate their compliance. And most importantly, they'll have evidence of their compliance in the form of successful audits.
ByteGrid has built their reputation as the only data center validated for compliance with FDA and HIPAA requirements. With proven performance and an expert compliance team, they can offer cloud CTMS hosting the only way that truly makes sense – safe, fast, and fully compliant.