Managing clinical trials effectively is laden with more complexity than ever in today’s clinical development landscape. Simplifying oversight starts with the right eClinical platform — using well designed technologies can unify disparate systems, streamline data collection, optimize user experience, and create an end-to-end, comprehensive toolbox for conducting a successful study across all study phases.
The functionality delivered by an eClinical platform can crosscut nearly every module and function of a clinical trial paradigm, from randomization to device and supply management to patient scheduling, facilitating clinical event adjudication and even managing payments. Coordinating and centralizing all of these moving parts is crucial to creating the efficiencies needed to remain agile in the modern clinical trial arena. Eliminating the need for multiple interfaces and untangling much of the burden that trial site personnel often face can be a critical benefit.
The advantages of a feature-rich eClinical platform are significant: from more complete and clean data collection to fewer deviations, lower costs, better site and patient retention, a unified solution can offer sponsors, patients, and trial teams alike a more efficient clinical trial experience. These days, it’s not a question of whether an eClinical platform can provide value, even in early phase trials, but how much. Ultimately, the right eClinical solution enables users to get a study up and running faster, provides broad enough capabilities to support a wide range of study protocols, can evolve over time and through multiple phases, and of course, is cost effective.
Despite the advantages these platforms can afford a study, many sponsors in may be reluctant to transition to a new eClinical platform, reasoning that their existing systems have worked for them in the past. Yet, as more eClinical products become available, selecting the right platform can be vital to study success. Intuitive, quick to learn, and easy-to-use software solutions improve efficiency and quality, saving time and money. As sites look at digital innovation, they also must consider sustainability. Site teams need software solutions that meet their needs today but won’t be outdated in a few years. They also want products that are flexible enough to adapt and integrate as new technologies emerge.
The Core Elements of an eClinical Platform
When it comes to clinical sites and trial teams, busy is an understatement ― the expansion of studies in the development pipeline, the increasing number of arms in a given study, and the shift in trial designs has culminated in an extremely high burden for those managing day-to-day research activities. Finding ways to ease site burden can greatly improve the speed at which initiation occurs, and support a site’s successful enrollment, follow-up, and close-out.
The most valuable eClinical platforms offer a centralized hub for all study elements. This means having a single login and a user-friendly, cohesive interface that integrates essential tools like:
- Electronic Data Capture (EDC): The heart of the platform, EDC allows for secure and efficient data entry for all study information.
- Informed Consent (eConsent): Using eConsent interfaces, patients have the option to electronically review and sign consent forms, streamlining the enrollment process.
- Electronic Patient Reported Outcomes (ePRO): With ePRO, patients can conveniently complete questionnaires and surveys directly, further optimizing participants’ user experience and assisting study sites with questionnaire collection.
- Safety and Event Monitoring: These tools enable streamlined reporting of adverse events and real-time monitoring for safety concerns.
- Endpoint Adjudication: The right eClinical platform should allow Adjudication Committees (CECs) to easily access and record critical safety observations to meet endpoints while providing complete visibility to the entire flow of review online with email notifications, To Do Lists, reporting tools, and accessibility to digital imaging from the same platform.
- Document Management: Digitalized document management allows for the secure, accessible storage and organization of all study documents.
- Randomization and Trial Supply Management (RTSM): RTSM integrated in an eClinical platform should provide automated assignment of treatment groups and tracking of investigational drugs or devices.
- DICOM Image Storage: These technologies support the secure storage and management of medical images, a capability especially useful for imaging-centric trials, especially when a Core or Central lab is being utilized.
By centralizing all functions needed to conduct a trial, eClinical platforms make study participation more appealing for a site, a crucial consideration in a paradigm where competition among sponsors for site participation is intensifying. Choosing a platform that can manage all study elements in one spot ― supported by easy-to-learn data entry, real-time data queries, and role-based to-do lists to easily manage sites’ pending tasks and reduce the number of times data needs to be touched ― can eliminate the amount of time a site spends on a study and can make study participation for a site more appealing.
The Benefits of Right-Sizing
While all studies require core functionalities, not every trial needs every feature. The best eClinical platforms offer a modular design, allowing sponsors to choose the tools they need and avoid paying for unnecessary functionalities. This keeps costs down and supports a streamlined user experience for all parties involved.
Some eClinical platforms can offer robust feature sets, as well as the flexibility to turn critical functionality on and off as needed. This also leads to greater pricing transparency, which can be helpful to trial sponsors when planning and budgeting for clinical programs. It is also particularly valuable to contract research organizations (CROs) when providing pricing estimates to clients for trials in various phases.
Cloud-based (SaaS) eClinical platforms offer several advantages over in-house solutions. First, they are typically more cost-effective, as subscription fees eliminate the upfront costs of hardware and software licenses and development. They also tend to be more scalable and are better able to meet the needs of different study sizes. Because the vendor manages updates to the software of these systems, as well as customer support, users will always have access to the latest features and security patches and assistance with technical questions. Finally, SaaS platforms should always generate data in a format readily accepted by regulatory bodies, simplifying study reporting and streamlining submissions.
Why Choose iMednet?
Mednet stands out as a leading eClinical platform provider due to its offering’s unique strengths:
- Highly Flexible: The iMednet platform allows for extensive end-user configuration choices to perfectly match the needs of each study.
- User-Friendly Design: Anyone can learn to design within iMednet, eliminating the need for any coding expertise.
- Exceptional Support: iMednet boasts a 5-star highly experienced and responsive support team to guide users throughout the study lifecycle.
iMednet offers seamless access to a modular, intuitive, and user-friendly eClinical platform that is both cost-effective and highly configurable. Backed by an experienced team and exceptional customer support, the iMednet platform provides a comprehensive suite of tools to support and manage all study types and phases. This ensures efficient and effective study conduct for all users and a solution that is flexible to adapt and integrate as new technologies emerge.