There are many companies out there offering their version of a clinical trial management system (CTMS), but that doesn’t mean they’re all the same. While many CTMS companies on the market claim to have all of the features and functionality that is required to successfully track and manage a clinical trial, most do not. What separates the greatest CTMS software from those claiming to be the greatest is the attention to detail that is often overlooked by less-established CTMS providers.
Keep In Mind – Users
Managers at research organizations might make the executive decision to research and adopt a CTMS, but the researchers are the people using it every day. Ensuring the selected CTMS supports the needs of both administrative and research users will help ensure better trial management.
Researchers need to be able to enter data in a way that is intuitive and consistent. This means the CTMS software being used should be easily navigable, well organized and designed to minimize the number of required clicks to accomplish a task. A great CTMS should also have easily generated reports that take the raw data, analyze it and present it in a way that researchers and administrators can benefit from it.
Adopting a CTMS is a major change for any research organization. If a CTMS software company does not offer comprehensive training on its products, organizations may be underutilizing the software or using it inefficiently, which could diminish the likelihood of success. Moreover, a lack of training could prevent research organizations from fully adopting the CTMS they purchased, wasting the money and time that was spent investing in the system. A leading CTMS software company should offer training and tutorials so research organizations can better themselves through the use of this new software.
Even with proper training, questions and requests will arise from any organization using a CTMS. Looking for a CTMS company that provides high quality, ongoing support is essential. Looking for a CTMS company that provides high quality, ongoing support is essential. Given that questions can arise at any time, research organizations should be able to contact the CTMS company support staff and receive assistance immediately. Partnering with a CTMS company that listens to the needs and wants of its customers and takes them seriously should be highly sought out.
Keep In Mind – Specs
When looking for a CTMS, it is important to understand the features associated with the software itself, as well as how these features can be used or adjusted to incorporate the specific needs of the purchasing organization.
Great CTMS software will integrate a wide variety of features that better help organizations report, track and analyze trial data. Features such as patient databases, recruitment, patient scheduling, financial management, document management and reporting all go into a CTMS that can effectively manage trials. Along with these features, some of the greatest CTMS software will be capable of providing web-recruitment services as well as regulatory modules. CTMS software companies that ignore these features are only capable of providing the basic services to their customers, and research organizations using these CTMS products typically see lower ROI and decreased profitability.
Software changes frequently. It is important that CTMS developers continue to release updates to make their CTMS software run more efficiently, and integrate new features that allow for optimized trial management. A CTMS company that understands its users are always evolving will consistently have software updates every few months.
It is important that your CTMS software is capable of recording and storing data in ways that comply with all facets of HIPAA, Safe Harbor and 21 CFR Part 11. Moreover, the applications should provide a full audit trail so all activities can be recorded.
7. Data Import
Whether switching from another CTMS, from a proprietary CTMS or from Microsoft Excel, the new CTMS company should be able to take existing data and impart it into the new CTMS. This way, companies are not burdened with the task of reentering data.
Most research organizations are also using services from other technology providers. It is important that CTMS software has the capabilities to integrate with other clinical tools; doing this further enhances the CTMS benefits for research organizations by giving them even more control. Great CTMS products are capable of integrating with EDC and EMR software, regulatory applications and other types of research tools.
Keep In Mind – Security
Protecting patient and trial data is essential to the success and continued operation of any research organization. Security should be a top priority for every CTMS on the market and working with a CTMS company who does not share this value should be avoided.
9. Secure Data Storage
Many CTMS companies host their products, and this requires partnering with an IT hosting company such as Rackspace, Amazon or Logicworks to store and host the CTMS software for each client. Ensuring that these companies can effectively store and protect confidential data, while also ensuring the CTMS product remains accessible at all times is essential. If a CTMS company is partnering with a company who does not value security, then avoid using that CTMS.
10. User Accounts
Having separate user accounts allows for better tracking of trial data and employee accountability. Some CTMS companies limit the number of users allowed on the CTMS and charge additional fees if more users are required. If this charge is too high, research organizations may have multiple people logging into one account, which raises concerns with HIPAA regulations. Having a CTMS that allows for unlimited users helps research organizations become more productive and remain compliant.
Keep In Mind – The Future
Where a company is now with its business is never exactly where it will be several years down the road. As the clinical trial industry evolves, so do the companies within the industry, so it is important to put some thought into the future while looking for a CTMS today.
11. Changing Needs
As an organization evolves, its needs are almost guaranteed to change. It is important to be partnered with a CTMS company that understands this and is open to working with its customers to ensure the CTMS allows users to effectively conduct clinical trials. A great CTMS company is always analyzing the industry and knows what’s coming before it is requested by customers.
As an organization conducting or managing clinical trials, expanding to generate more business is always a possibility. This expansion may be through the addition of trials at existing locations, or through the addition of multiple trial locations both globally and domestically. Taking into account potential business expansion in the future is a necessary step today before selecting a CTMS. There are many CTMS companies that have software that is capable of scaling along with trial growth. Some CTMS companies embrace this and even offer multiple CTMS software options that fit various types of growth.
Tying it All Together
By understanding the needs of everyday users, the necessary product specifications, the level of security and the potential growth of the organization, research organizations can more easily filter through the noise in the CTMS market in order to find the optimum software, such as Bio-Optronics Clinical Conductor, that is capable of meeting their needs and generating success.
With Clinical Conductor, the primary focus is on making the right fit between the software and the organization. With decades of experience in the CTMS industry, Clinical Conductor has been designed to integrate the unique needs of every client into the software; and with numerous features, Clinical Conductor can provide additional benefits not typically seen in a CTMS. Clinical Conductor support staff work closely with clients, integrating existing data into the system, performing introductory training and taking support calls for questions and issues at all hours. Clinical Conductor is the only CTMS that brings together customization, adaptation, security and support directly into its software.