Electronic Clinical Trial Management Systems (E- CTMS) - the Challenges, Solution and Benefits

Managing clinical trials are quite complicated as the healthcare industry is highly regulated and the increasingly global marketplace can be extremely challenging. It calls for an integrated, end-to-end approach that synchronously provides visibility into trial costs, study timelines, and regulatory compliances. Technology comes to the aid of clinical researchers in addressing some of these challenges.

Yet, Electronic Clinical Trial Management System can be vulnerable to organizational boundaries, siloed information, different systems, and non-standardized processes, resulting in an unnerving case of “You don’t know what you don’t know.” Clinical investigators need to adapt a system that allows them to seamlessly integrate all aspects of study management including scheduling, tracking compliances, coordinating with other researchers and participants, and maintaining records with audit trail. The ultimate objective is to fast-track and fool-proof product development.

For several years, increasing numbers of healthcare organizations have implemented Electronic Clinical Trial Management Systems (E-CTMS) that can provide insights collected from the system’s data to gain early and increased visibility into problems, progress, and possibilities.

Many organizations have a constant need to expand Electronic Clinical Trial Management System capabilities, integrate clinical operations data across multiple systems, and update clinical trial developments – all in order to prepare for changing regulatory requirements and clinical trial practices. This is the obstacle faced by clinical researchers and lead investigators when choosing a CTMS solution to manage clinical trials – go with an existing solution or explore alternative options.

CTMS – Solution and Benefits

A standard Clinical Trial Management System defines and manages all of the activities that span the lengthy and rigorous clinical trial processes.

A CTMS can assure clinical researchers that “you know what you should know.” It transcends organizational boundaries, develops interoperability, and reports evolving regulatory standards. It retains and manages clinical trial planning, preparation, performance, and reporting, with a significance on keeping up-to-date contact information for experimental applicants and trailing targets and milestones (e.g., for obtaining regulatory approval, distributing drug supplies, or issuing progress reports). Typically, an Electronic Clinical Trial Management System (E-CTMS) provides data to business intelligence (BI) method, which acts as a digital dashboard for clinical trial managers.

A healthcare organization exploring the selection of a CTMS should expect the solution to deliver the following core competencies:

• Clinical platform/project management - Allows oversight of associated clinical trials per supportive area based on a set of specific clinical project accomplishments (i.e., tracking actual vs. target). Includes the facility to track progress at detailed trial and program levels.
• Trial and site planning - Enables investigator and site identification and recruitment, including key trial milestone tracking such as target enrollment metrics for each study country.
• Site and subject management - Provides facility for site monitoring, subject enrollment relative to the proposal, and Case Report Form (CRF)/ Electronic Case Report Form (eCRF) completion status. Includes organization visits/trip reports.
• Study management - Tracks key data such as CRF collection, Clinical Research Associate (CRA) monitoring rate, procedure visit frequency, and adherence to protocol regiments. Includes support for study records and trailing tasks.
• Investigator management - Allows the trial sponsor to manage relationships with investigators, based on prominence in the status study data and related status with CROs and/or investigator sites.
• Study finance and investigator grants and payment management - Supports financial management including tracking study costs, refunding investigators, and paying claims related to study activities. Includes payment management and management of financial disclosure.
• Clinical supply management including supply tracking - Accomplishes clinical supplies.
• Clinical trial routine and reporting - Provides reporting/dashboards to communicate experimental performance against objectives, as well as other operational reports.

The benefits of using a CTMS can be significant and outweigh such challenges. Potential benefits include:

• Enhanced clinical operations decision making resulting from more proficient trial planning/tracking milestones via administrative management dashboards and metrics reporting
• Increased experimental investigator selection rates and performance trailing management
• Help to manage clinical trial costs/payments and clinical drug supplies tracking
• Enriched relationship regulatory across the clinical trial process (CRO, investigator and sponsor)
• Accurate financial reporting with improved ability to achieve tasks of individual studies and the complete set of clinical programs
• Enhanced data quality through the use of consistent languages, including dictionaries, to avoid confusion and ambiguity of clinical trial data meaning.

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