According to the Tufts Centre for the Study of Drug Development (Tufts CSDD) study, at least one protocol change happens in more than half of all clinical trials. These changes have the potential to destabilize locations and research teams, causing inefficiencies. For example, if a change affects how therapy is administered or how and what data is collected, sites may need to re-consent with a patient. Changes in research procedures cause big logistical issues for everyone involved and waste a lot of time, especially when it comes to clinical trial data gathering.

Modern EDC Systems Must Accommodate Protocol Amendments

Data collection and patient visit schedules are disrupted if a protocol amendment necessitates. According to the Tufts CSDD research, clinical trials average 2.2 to 2.3 protocol revisions. This means that electronic data capture in clinical trials may have to be shut down several times, which is both disruptive and wasteful. Given the frequency with which changes occur, EDC systems should be built to sustain regular operations while adapting to changes.

Amendments that codify clinical trial data gathering, on the other hand, must be explicitly indicated for users to ensure that each modification is implemented throughout the study. If a new field is introduced to a form, the user interface should make it apparent that the new field must be filled out. Otherwise, clinical research coordinators may overlook the addition of a new item to their process. These sorts of notifications are straightforward but useful procedures that should be common in EDC systems. A clear approach for training or retraining users on any new feature should be included as part of that infrastructure.

Adaptable Designs, Adaptable EDC

Clinical trial design is becoming increasingly difficult. Adaptive trials, for example, evolve over time, which means that an EDC system must account for every conceivable path the trial may take. There are also several types of trials, such as basket, umbrella, and platform, each of which need a versatile electronic data capture software for clinical trials. As sponsors employ a broader range of complicated clinical trial designs, their EDC systems must be capable of implementing complex changes—often in the middle of a study.

Telehealth consultations quickly became a viable and essential alternative to in-person sessions during the COVID-19 epidemic. Remote visits in clinical trials increased in 2020 and 2021 as a result of site closures, travel limitations, and patients' reluctance to attend a medical center. Data from telemedicine platforms, wearables, sensors, and other sources must be integrated into EDC systems for this decentralized research. They also need the capability and flexibility to support numerous treatment arms as well as the mid-study adjustments that are inherent in adaptive trial designs.

Octalsoft EDC Supports the Next Era of Clinical Data Management

Octalsoft is constantly improving electronic data capture systems to match the flexibility demands of current clinical trials. EDC does not need any downtime for protocol changes. Following implementation, site users are automatically allocated the tasks necessary to accommodate the change, and revised eCRF completion criteria may be published and made instantly accessible, informing site users about the eCRF modifications and what new/changed data are required. Once a modification is made, it may be implemented without disrupting patient site appointments or bringing the entire system down. The ultimate goal: consistent, uninterrupted performance.

For reporting reasons, effective electronic data capture solutions log all modifications so users know when and how they were applied. modifies can also be reversed if, for example, a patient withdraws consent following a protocol modification that modifies what data they must supply. EDC saves users time by automating as many of these procedures as possible, allowing them to focus more on patients and the day-to-day operations of clinical trials.

Although all aspects of a clinical trial are rigorously monitored, studies are becoming increasingly complicated, protocol changes are regular, and recruitment is unpredictable. Furthermore, our environment is continually and rapidly changing, which has a direct influence on both trials and participants. 

There are three core reasons why Octalsoft EDC is a firm favorite for clinical data management, clinical operations, and clinical database programming teams:

1. High Configurability

The majority of EDC studies may be built without the use of special functions. A study's components may be customized in 95% of cases. Octalsoft and our clients both have libraries of reusable custom functions to help them construct new studies faster. Customers can employ EDC's Professional Services team or create their own sophisticated research. Other solutions may need the development of additional functionality by a vendor in order to support a certain protocol.  

2. Flexibility

EDC enables the ability to personalize the study construct and execute any protocol amendment or other mid-study design modification to provide support for any protocol, including complex adaptive designs and master protocols.

3. Transformational Study Build Processes

Octalsoft is dedicated to streamlining operations while maintaining quality and efficacy. By allowing greater study-build customization through the user interface, our next-generation study design technology changes the process. This novel method incorporates complicated casebook dynamic behavior. Because clinical data capture is no longer limited to EDC, we're centralizing the definition of a study across applications, including developing data source agnostic edit checks and data definitions (i.e., the same data definitions and edit checks would apply whether collected via EDC or eCOA).

Many of the edit checks we write now (to account for all eventualities) never run. A recent study at a big pharma customer revealed that anywhere from 45% to 75% of scheduled edit checks were never completed.

Octalsoft is enabling a more intelligent, risk-based approach to building research. As part of our next-generation data platform that supports the progression of clinical data management to clinical data science, we maintain data quality by concentrating edit check development on the most prevalent cases and employing AI/ML to detect data abnormalities. As a result, the amount of custom programming necessary to implement research will be reduced. 

These three fundamental elements result in simplified study builds, which speed up the study construction procedure for many clinical studies.

Conclusion

To meet the clinical trial landscape's complexity and unpredictability, the only logical technology solution is a system with the functionality, adaptability, and flexibility to properly fit with your research. This necessitates the use of a system that is adaptable, can use pre-existing custom functions, and can create new custom functions to meet specific needs. If your EDC lacks them, it will be unable to expand and accommodate the rising number of complex/innovative trials.

This adaptability is one of the primary reasons Octalsoft's EDC has been chosen by over 30,000 users.

Octalsoft's staff collaborates with you to understand your study objectives, study design, and any special requirements. Alternatively, our training experts will assist you in creating your own studies. 

Want to know more about how Octalsoft can help boost the flexibility and modularity of your next clinical trial? Book a demo with us today.