Navigating the eClinical Ecosystem: Clarifying the Alphabet Soup

The technology landscape has revolutionized clinical trial operations, with clear goals to enhance efficiency, patient-centricity, data quality, and connectivity between sites and sponsors. Central to this transformation are eClinical Solutions, primarily cloud-based SaaS platforms and digital tools designed to streamline trial management. However, these solutions can either be sponsor-provided (central) or directly purchased by sites, introducing an additional layer of complexity to this intricate web, as they target diverse end users including sponsors, CROs, and sites.

At one of the first global conferences I attended, within the massive exhibit hall of over 4,000 attendees, I quickly melted into the bowl of acronym soup associated with naming these solutions. If you’re as overwhelmed, as I was, whether you’re new to the clinical industry, or just trying to navigate within an area where electronic platforms meant to simplify paper processes have instead created duplications and overlaps, this blog will serve as your buoy. Here, you’ll find clear definitions and useful context to help you navigate through the complex eClinical solution ecosystem.

Site-Enablement Platforms

At the center of the eClinical solutions spectrum lies site-enablement platforms, referred to because they prioritize the needs of the research site, and bridge sites, sponsors and contract research organizations (CROs) throughout the clinical trial process. The primary users of these solutions are research team members at the clinical trial site. These solutions may be purchased by a given sponsor and provided to the site for specific studies, or they may be directly purchased by the site for centralized site management of their protocols, subject to site policies and procedures.

• Electronic Binders (eBinders): By digitizing clinical trial operations, eBinders offer secure storage, retrieval, and exchange of trial documents, eliminating the necessity for physical paper. Essential documents required in the investigator site files (eISF) and regulatory binder (eReg), including protocols, informed consents, investigator brochures, and delegation of authority logs, can be centralized within a dedicated solution. eISF/eReg platforms allow for real-time document sharing and management, routing signatures, ensuring regulatory compliance, and reducing administrative burden.
• Clinical Trial Management Systems (CTMS): Clinical Trial Management Systems (CTMS) provide operational support for trials, including enrollment and patient tracking, staff information, and key document storage. Depending on the vendor’s solution, there may be overlaps in capabilities, such that key regulatory documents may be housed within a site’s CTMS platform rather than a separate solution. These platforms offer remote monitoring with varying levels of access and document transparency, enabling sponsors and CROs to review required site source data and documentation.
• Electronic Drug Accountability Software (eDAR): Site users, often pharmacy team members, assigned to the storage, handling, and dispensing of investigational products (IP) generally use specialized electronic drug accountability software (eDAR) that aids in daily operational tasks. Automated workflows and digital IP accountability processes eliminate manual documentation on paper logs and forms, optimizing standardization. eDAR software can also function as a document storage platform, substituting the paper pharmacy binder, and includes documents related to IP receipt, accountability, temperature control, and other essential pharmacy requirements.

With inventory oversight, alerts, reports, and supply calculators, sites achieve enhanced and streamlined operations. Centralized access allows monitors remote capabilities to review inventory information, temperature reports, and other necessary documentation for proper auditing of trial conduct. Often, due to blinding requirements, these documents are separated from the eISF/eReg platforms.

Sponsor Operations

In examining the sponsor side, numerous eClinical platforms provide services across various operational areas, encompassing study planning, protocol design, training, clinical supplies, and regulatory information management. Vendors generally offer comprehensive services and may be selected for complete or partial requirements of a particular trial. It is common to employ multiple providers for specialized services, depending on specific protocol needs, contractual obligations, or other business partnerships.

To elaborate on commonly used acronyms, the Electronic Trial Master File (eTMF) has established itself as an industry standard. The eTMF serves as the centralized repository for all trial activities from inception to completion, including essential study documents, training materials, safety documentation, monitoring visit records, and participant information. The sponsor’s eTMF aggregates and stores data associated with each research site in the trial, with most of the documentation originating from external sources (analogous to compiling all individual sites’ eISFs).

Sponsors frequently utilize a Randomization Trial Management System (RTMS), also known as Interactive Response Technology (IRT), to manage inventory and drug supply for a given trial. As a sponsor-procured solution, RTMS/IRT enables sites to perform subject randomization and allocate treatments based on the specific assigned inventory to be dispensed to patients. For the site, the RTMS/IRT system manages only the specific trial, posing complexities in the overall management of investigational products across all studies at the site.

Sponsors may also utilize a clinical trial management system (CTMS) to ensure comprehensive project management across their entire trial portfolio. This system centralizes and automates various aspects of the trial process, including study planning, personnel management, participant recruitment and tracking, reporting, and analytics. Similar to site-level systems, sponsor-based CTMS provides real-time access to data, monitors trial progress, and enhances transparency and collaboration among multiple stakeholders involved in the trial (e.g., Sponsor and CRO), thereby facilitating better decision-making and planning.

Participant Data Collection & Management  

eSource platforms provide efficient and paperless data management to streamline daily trial operations by enabling direct data capture from the source, whether it is a patient, clinical site, or laboratory. At the other end of the solution spectrum, participant data collection and management can include eSource solutions such as electronic clinical outcomes assessment (eCOA), electronic patient-reported outcomes (ePRO), wearables, and telemedicine. The shift to paperless clinical trial operations impacts patient quality and experience by reducing the need for frequent site visits and extensive paperwork. Patients can report their outcomes and participate in trials from their homes, which can lead to improved compliance and retention rates. However, the adoption of technology requires training for both clinicians and patients, support assistance, and considerations such as access to reliable internet, health literacy, and dexterity required to operate these devices.

With the gradual adoption of eSource, there has been a noticeable shift away from using the term EDC. Electronic data capture (EDC) refers to the digital recording of subject-reported information collected during clinical trials. Provided by sponsors for specific trials, EDC systems are designed to capture the necessary elements outlined in a given protocol. Traditionally, data was first recorded on paper case report forms (CRFs) and subsequently transcribed into the EDC. Alternatively, data can be directly entered into the EDC through an electronic case report form (eCRF), typically within a secure database. Increasingly, this data originates from other systems, such as electronic health records (EHRs), which are then integrated with the EDC to centralize data capture.

Integrations

A major advancement within technology platforms is the ease and ability to integrate with one another, creating an intricately connected ecosystem.  Integrations between software platforms can optimize operations within a clinical site, as well as between the site and sponsor. At the site, integrations such as CTMS to eISF/eReg, and CTMS to eDARF, EHR to eDARF, EHR to EDC, align data under a single source of truth, eliminating duplication and improving accuracy.  Providing streamlined, electronic communication between research teams, optimizes resources and eliminates tedious paper practices, such as manual charting, paper orders, printing of treatment assignments and patient-visit lists.

Connecting sites and sponsors, several eBinder portals provide secure, direct document exchange from the sponsor to site; substantially aiding in the study start-up process, protocols and amendments dissemination, and ensuring timely training, signatures, and approvals. Often hundreds of pages long, the transition to electronic protocol documents vastly reduces the environmental impact of the paper trail, and conserves physical space within multiple areas of the research site: regulatory, clinics, and pharmacy. Integrations between the site’s eISF and sponsor’s eTMF, syncs site documents, improves data quality, completeness and timeliness. Additionally, any issues can be quickly identified, promoting compliance and trial integrity.

Quick Reference: Key eClinical Acronyms and Their Functions

Conclusion

eTMF, RTMS, CTMS, eDAR, and eSource have revolutionized clinical trials by centralizing processes, enhancing data accuracy, and improving patient experiences. These platforms create an interconnected ecosystem that streamlines workflows, eliminates paper inefficiencies, and fosters site-sponsor collaboration. As clinical trials evolve, sites, sponsors, and vendors must align to ensure eClinical platforms continue to enhance efficiency and integration. Continuous innovation and integration will be key as eClinical platforms further evolve to meet the ever-changing needs of clinical research.

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