Your CTMS should represent your genuine needs and exclude everything unnecessary. This excerpt from our whitepaper, "How the Right CTMS Enables Meaningful Data Ownership," demonstrates how rethinking your approach to system selection and pricing alternatives may lead to more meaningful data ownership and more successful trial data management.
Ease of adoption: getting data in, but also getting it out
It's simpler to accept pre-existing systems. However, the inherent difficulties of moving and/or converting data into your preferred system are numerous.
The unintended consequence of passive acceptance is out-of-scope change orders—a partner may be quite ready to spend time rearranging data into a desired format and charging for it. In other cases, the data owner may feel imprisoned by a solution that does not allow them to extract the data on their own. In such a case, the data owner may be forced to wait for a partner or vendor to reply while losing access to their data and incurring ever-increasing time and financial obligations.
"The bottom line for data owners is this: you own the data. Why leave that data dispersed across various systems or departments, or within systems that are not 21 CFR Part 11-compliant, out of your reach, supervision, and usage?No data owner (sponsor or otherwise) should be forced to use a system/vendor/process selected by another organization for the purposes and preferences of that organization. Instead, data owners should reclaim control of their data by adopting a well-designed, feature-rich solution designed to enable genuine data ownership."
-Hiren Thakkar, MD - Octalsoft
Many sponsors may see this as inverting the normal relationship: picking a system with features based on their own needs, and then collaborating with their CRO partners to efficiently use such tools (while still employing the CRO to provide knowledge in their specific field). Others may see data ownership as part of the wider picture of reverting to an in-house strategy.
Affordability provides flexibility—adjusting to your needs, for your growth
CTMS systems for clinical trials have traditionally followed a typical pricing model in which clients are expected to sign a long-term contract and pay for features they do not require—a system that benefits the vendor but gives little benefits to the buyer (other than securing long-term access to a system).
A flexible subscription model is a new option. Instead of committing to services in advance, sponsors can choose and pay for services on a monthly basis. This architecture also supports budget-sensitive research and programs by allowing for team and feature scalability. True affordability is about providing you with what you need rather than what you don't.
Keep a look out for additional or hidden charges, as well as dependencies that are not included in the initial pricing, such as:
- Initiation costs, or charges for actually utilizing your purchase
- Support costs, customer support charges, or up-to-date training materials
- Study setup expenses are sometimes an unexpected extra expenditure.
One of the primary benefits of acquiring a feature-rich CTMS software clinical trials with all of the included capabilities is that it eliminates the complication and unnecessary expense of pricing numerous distinct systems with different connectors, fees, and integration specialists.
Rather, choosing a vendor who offers on-demand, subscription-based pricing will assist in ensuring a quick setup while only paying for what you require. Choosing a CTMS solutions provider who prioritizes competent, high-quality service will help you prevent issues later on.
Vendor expertise
All of the previously described criteria, tools, and features can help with research success, but each trial has its own set of requirements. Consider an ideal clinical toolset to be a pocketknife, with numerous unique and meaningful instruments readily available.
Much of the value of each of these components and services is driven by vendor expertise—the craftsmanship, user experience, and relevancy of offerings are immensely better when founded on boots-on-the-ground experience and an awareness of day-to-day needs. It is generally wise in the eClinical tools market to invest in a solution developed by folks with genuine industry expertise.
In Summation
The value of first-hand information cannot be overestimated, so spend some time researching your options. How did the product come to be? Inquire about a vendor's or partner's data-hosting platforms and platform suppliers. These connections can all be useful in the decision-making process. Want to know more about how Octalsoft’s CTMS can offer your clinical trial an unmatched level of flexibility?
