Clinical site monitoring is among the most critical functions of a clinical trial.
Monitors play a key role in selecting trial sites and ensuring that business objectives are met, the trial is compliant with regulations, the data collected are sound, and that participants are safe and protected.
However, as trials become increasingly complex, oversight also becomes increasingly difficult and time-consuming.
In some therapeutic areas, site overhead costs to monitor trials can be up to a third of the entire clinical trial budget.
Of course, more complicated trials help produce urgently needed clinical information and support better product development. But they also bring several other challenges for site monitoring. For example:
- Increased difficulty managing, storing, and communicating data between multiple sites and stakeholders.
- Complex regulatory compliance, data security, and record-keeping.
- Higher management, IT, and analysis costs.
These challenges often translate into wasted time and effort, with disastrous consequences.
The longer a trial lasts, the more money pharma companies lose, both from missed product revenue and the cost of the trial itself - sometimes to the tune of billions of wasted dollars.
Pharma companies have a pressing need to make clinical trials site monitoring more efficient, transparent, and fast - all while substantially reducing costs.
Of course, there's some hope here - the FDA allows risk-based adjustment of monitoring procedures, which can save valuable time and resources by focusing monitoring on the highest-risk trial environments.
Clinical trial management systems (CTMS) software can also address some of these issues by providing a platform through which to manage and track information about participants and trial sites.
However, the majority of trials now involve multiple sites and multiple stakeholders. Traditionally, computing can make it difficult to communicate critical trial information, and translating between different systems often wastes valuable time.
The increased network burden of processing complex information also makes trials more expensive, and also in many cases vulnerable to data breaches or network outages.
Enter cloud computing:
Cloud computing-based CTMS solutions offer an immediate, low-cost way to simply site monitoring processes and make trials run more smoothly and faster.
In the long run, this translates to lower research & development costs and better decision making.
Here Are Just A Few Of The Ways Cloud Computing Simplifies Clinical Site Monitoring
1. By Facilitating Cheaper & More Flexible Data Access
Cloud computing reduces the IT costs of site monitoring and speeds up data monitoring.
Instead of storing and managing data in servers on-site, cloud-based solutions enable companies of any size to essentially rent space within a distributed network that can be accessed anywhere with an internet connection.
Put another way, cloud-based CTMS provide on-demand data storage and access on a pay-for-use basis, allowing users to store large quantities of data in a convenient and connected virtual location.
The immediate benefits of this switch include lower hardware and maintenance costs and increased network reliability.
Instead of purchasing servers, installing software at each site, and then validating, documenting, and maintaining all trial records in-house, cloud-computing allows for more flexible computing and reduced need for IT staff.
In fact, IBM estimates that cloud computing could reduce IT spending by up to a quarter.
Cloud-based models also reduce financial risk, as purchases are spread out over a longer period of time and can typically be scaled based on need.
2. By Managing Site Visit Schedules On Both Sides
Cloud-based CTMS helps create an efficient scheduling process from both the research site side and for monitors.
Coordinating target dates for future visits often require significant time - without a good CTMS solution, these appointments are often typically transcribed into Excel spreadsheets and then updated manually every day.
On top of all the time this takes, there's significant room for error.
Cloud-based CTMS provide an easily viewable daily schedule and tasks and let monitors store, quickly retrieve, and visit details.
Both parties can easily access scheduling windows and coordinate times for scheduled visits, and provide an easy-to-read summary of the time since the last visit was performed.
After a visit, the software can automatically generate a record of the visit for financial and regulatory oversight down the road.
3. By Making Communication Between Stakeholders Easier
CTMS based in the cloud provides a single record of shared study information and makes it easier to access and use.
Trial monitors often act as liaisons between diverse stakeholders, like:
- Research sponsors (in academia, the government, non-for-profits, industry, etc.)
- Clinical investigators/medical providers
- Payers/Funding Bodies
- Regulatory bodies (the FDA, IRB boards, etc.)
These stakeholders must all cooperate and communicate with each other regarding important trial details.
Working off of the cloud to do this can lead to problems with version control or communication breakdown.
In the worst case scenario, this could mean study investigators working off of divergent, out of date or incorrect information.
If you regularly find yourself taking significant time calling or emailing study personnel to track down specific documentation on a subject or protocol, a cloud-based solution could significantly cut down on administrative time.
As a concrete example, the cloud enables all AEs/SAEs or protocol deviations to be instantly and directly added electronically to a site monitor's trip report, ensuring that the information will be instantly available to all relevant parties.
Authorized users can easily view and interpret complete trip reports electronically; cloud computing provides a single source for information related to trials, breaking down silos.
This also means that overall site performance is easier to track.
4. By Providing Better Data Security and Reliable Access to Information
As valuable as trial site monitoring data are to pharma trial management, they also present an increasingly lucrative target for hackers.
With the increased use of electronic records throughout the healthcare system, data security is - with good reason - one of the top concerns for clinical trial management.
The cloud, luckily, has made significant strides in security in recent years. Confidential participant data can be stored in a HIPAA-compliant secured data center with multiple layers of security.
Microsoft's data centers have some of the most advanced security protocols in the world.
In fact, the cloud is now more secure against hacks than typical on-site servers.
Another benefit of decentralized computing power is increased resilience and reliability: cloud-based computing offers better fail-over and disaster recovery.
Microsoft has distributed its secure servers all around the world. Unlike on-site servers, even if a hurricane were to take out an entire geographical region, you could still conduct clinical management, and your data would still be secure and accessible in the cloud.
In addition to safety from hacking, the technology also protects against data loss with backup and recovery support of vital information.
5. By Offering Fast Electronic Access to Financial and Regulatory Documentation
Using cloud-based systems to create or store study documents of interest to site monitors minimizes personnel interactions with monitors.
In turn, this also minimizes study interruptions and repeat document requests by instantly locating all often-requested documents in a secure online space for site monitor access.
The cloud can also provide easier access to:
- Financial documentation (e.g. Sunshine Act and sponsor compensation record keeping)
- Regulatory documents, including electronic medical records (EMR)
Particularly in trials which are shifting to increasingly remote monitoring (such as risk-adjusted monitoring situations), this capability can dramatically reduce hours wasted in paper pushing and less-important administrative tasks.
Site monitors/CTAs can then focus their time on the most critical oversight areas.
6. By Standardizing Record Keeping
Trying to record these results of site visits manually quickly turns into a logistical nightmare. For starters, these scenarios might sound familiar:
- There are data inconsistencies between different spreadsheets or reporting systems
- Misplaced records or computer errors lead to lost data
- Adapting to different trial sites requires different software and data recording methods
- Recording and reporting visit data on time becomes next to impossible
Fortunately, once all study data are securely in a singular cloud location, entering data from any computer makes it accessible without the need to convert it to any other format or system.
Using a cloud CTMS, it's possible to pull data from other systems such as EDC/IRC and external clinical trial management systems and then export it in Excel without building new data warehouses.
The standardization embedded in a cloud-based solution also eliminates the need to adapt monitoring procedures to different sites.
Standardized fields for entering data also help eliminate incorrect entry through human error, which leads to better compliance and easier information retrieval down the road.
Cloud Computing Maximizes the Efficiency of Clinical Trial Site Monitoring
Big pharma through small life-science startups alike can realize significant cost savings and faster clinical trial operations by adopting - or converting existing CTMS to - cloud computing solutions for site monitoring.
On top of cheaper and more reliable data storage, cloud-based CTMS helps:
- Manage site selection, status, visits, and trips.
- Manage documents and activities end-to-end with a global view in one unified, secure, reliable system.
- Keep track of financial and regulatory reporting documents in the same place, including physician-researcher payment records for Sunshine Act reporting as well as business financial planning and payment records.
Cloud-based pharma CTMS solutions enable successful, cost-effective, and secure clinical pharma trial site monitoring through rich trial life-cycle analytics, streamlined management processes, and lower-cost computing.
These are just a few of the ways cloud computing can make an impact for clinical trial site monitoring. There's plenty more to be said, so if you have ideas or comments not covered here, please let us know below!
Want to learn more about how cloud CTMS solutions are accelerating clinical trials? Get in touch now to see how cloud computing can simplify and magnify the impact of your organization's medical trials.