As the coordinator or manager of a clinical trial, you will have one simple goal: You would want your clinical trial to be successful. After all, it is your responsibility.
However, to guarantee success, you need to be able to manage the project efficiently.
It is of prime importance that, at any time during the project, you have the ability to get a good overview of the progress of the study; that you can plan tasks, activities, and responsibilities; that you can track and monitor any action; and that you can easily organize all clinical study relevant documents and information.
But what system can make all these possible?
Are simple lists generated in Excel sufficient for recording all relevant information and documents? Are the lists clear and well-structured to control the development of my clinical study? Should I implement a Clinical Trial Management System (CTMS)?
If considerations like leave you with a sense of déjà vu, then you are in the right place to get some answers.
After all, the devil is in the detail!
It is important to know which information we need to record for reliable planning and monitoring of tasks and activities in managing clinical trials. We can only make the right decision if we are aware of the requirements.
Unfortunately, this decision is often made in favor of an MS Office package (or comparable programs) without any serious consideration. I can understand that people are used to working with these applications on a day-to-day basis and with the help of these programs it is easy to come up with an overview list in a short time.
The real problem, however, lies in listings that can get out of hand quickly. As a result, there would be a plethora of documents and their different versions. Such a decentralized organization of information in multiple listings frequently leads to great complexity and confusion.
“Which version of which document shows me the truth?”
To make things worse, lists of different versions or revision status could be in circulation. You would soon be wondering which version of which document shows you what you need to know. In the worst case, members of the study team waste precious time working on the basis of divergent and/or not up-to-date information.
“Why does it look completely different on my screen?”
The completely different look syndrome stems from simple technical issues like incompatible program versions being installed by different users. If you are running a complex trial with an international study team, simple lists probably will result in disappointment and confusion in the long run.
So what is the alternative solution? Can a Clinical Trial Management Software (CTMS) help to improve the working routine for you and your study team? The answer is, a qualified yes.
I qualify my statement because the implementation of such a system calls for some additional effort. Also, in the beginning, not everyone will be thrilled to leave their “comfort zone MS-Office”. However, in my experience, it is worth the investment as the CTMS comes with the following strengths and benefits:
- Approach of centricity
One big advantage with a CTMS is that study-relevant clinical data and information coming from different sources are organized centrally in one system. The same version of information is made available to all the members of the study team. Every member is on the same page – at all times during your clinical study.
- Continuity for audit readiness
The collection of diverse information on your clinical trial’s progress all in one place makes the clinical study management much more comfortable for the whole clinical study team. Regular and timely checks and follow-up of clinical study activities and documents with regard to completeness and critical milestones can be performed with ease. Thus, your clinical trial is audit ready at all times.
A Clinical Trial Management Software provides you with a comprehensive overview of your clinical study at every step. In accordance, you can continuously monitor the progress of your clinical trial and selectively plan and control your activities.
With a CTMS, you have your clinical trial in view at all times, you can identify potential problems (e.g. logistical issues) very early and can initiate corrective actions immediately. Also, entry errors can be minimized as a CTMS allows for (automated) quality checks within and between data sets.
Be it CDISC or any other described standards of data availability in the CTMS, the system is very flexible and can be tailored towards the specific needs of your clinical trial.
If a CTMS is so capable, then why is a Clinical Trial Oversight Software (CTOS) necessary?
Well, to tell you the truth, the ‘M’ for Management in CTMS is no longer applicable to large scale clinical trials. Clinical trials spanning geographies often work with several CROs to conduct proceedings. These CROs have a management system of their own where they hold and manage the clinical trial data. With several CROs comes the problem of more than one CTMS. These disparate systems do not talk to each other. As summarized in this article, the important thing for the sponsor to do is oversee and not manage. That brings us to the CTOS.
Why Clinical Oversight?
Starting from the protocol development stage to IND/NDA submission to Regulatory authorities, the basic idea of clinical trial oversight is the identification of the risks on a continuous basis for all risk‐bearing activities throughout the clinical trials. This risk identification is done on the basis of existing and ongoing or emerging information about the investigational product(s).
By applying risk-based quality management approaches to clinical trials one can facilitate better and more informed decision making while making the most of the available resources. It is a prerogative of all involved parties to contribute to the delivery of an effective risk‐based quality management system.
How different is a CTOS?
A significantly large percent of sponsors and CROs still rely on manual processes and spreadsheets even though they probably have some sort of a CTMS in place. They are forced to extract data from different systems, so ultimately, they’re pulling everything together in spreadsheets and other manual tools in order to get a full-picture view.
What sets advanced trial oversight solutions apart is their ability to bring together all of the trial data (from all spreadsheets, data contained in different CTMS of CROs) all in one place without a big investment. Be it risk-based monitoring, data-driven enrollment decisions, or other data-driven mechanisms, the individuals involved in the study have a single place to go for that information. It’s a more efficient way to manage things.
Implementing a CTOS will offer you a number of significant advantages, listed below.
Faster trials: CTOS will equip study teams with easy to use role-based dashboards and streamlined navigation that will improve productivity and speedy trial execution.
Better decision making: It will also enable proactive closed-loop issue management and improve strategic trial planning with a complete real-time view of trial status.
Streamlined clinical operations: Finally, a CTOS will provide one seamless system of record for shared CTMS, TMF, and study start-up content, improving efficiency and streamlining operations.
What does the future hold?
Speaking from a process and a technology standpoint, the industry is going to see sponsors and CROs start to work more collaboratively together because both parties will need access to integrated data in at least near real-time. Emerging technologies hold out a promise to be key enablers for both the formulation and execution of strategy. To be prepared for what’s coming, organizations need to look at their entire process first and find the hidden manual processes – and eliminate them. They can overcome their inefficiencies by implementing technology solutions that enable transparency, agility and anticipatory oversight with the able support of technology like MaxisIt’s Clinical Trial Oversight Software (CTOS).
At MaxisIT, we clearly understand strategic priorities within clinical R&D, and we can resonate that well with our similar experiences of implementing solutions for improving Clinical Development Portfolio via an integrated platform-based approach; which delivers timely access to study specific as well as standardized and aggregated clinical data, allows efficient data quality management, clinical reviews, and statistical computing.
Moreover, it provides capabilities for planned vs. actual trending, optimization, as well as for fraud detection and risk-based monitoring. MaxisIT’s Integrated Technology Platform is a purpose-built solution, which helps Pharmaceutical & Life sciences industry by “Empowering Business Stakeholders with Integrated Computing, and Self-service Analytics in the strategically externalized enterprise environment with major focus on the core clinical operations data as well as clinical information assets; which allows improved control over externalized, CROs and partners driven, clinical ecosystem; and enable in-time decision support, continuous monitoring over regulatory compliance, and greater operational efficiency at a measurable rate”.