Cover Story

Clinical trial processes are vital, evaluatory research methods, wherein the effects of new medical treatments and drugs are tested on voluntary participants across four phases. Though clinical trials are meticulously designed, there are unforeseen obstacles such as discordant systems, regulatory restrictions, and siloed data that may hinder their seamless functioning.

A Clinical Trial Management System or CTMS is a revolutionary innovation that effectively organizes and manages the clinical trial process. CTMS is a boon to the life science industry, and it provides preemptive insights into the research process. Veeva is a flourishing company that has changed the pace of CTMS with its cloud-based system, Vault CTMS. 

The creative force behind Veeva, Peter Gassner, the company’s Founder and CEO, stated, “I founded Veeva with the belief that vertical cloud software would be the next wave of cloud innovation.” Today, the company is globally recognized as one of the top growth countries, including the Forbes Fast Tech 25 list.

Conventional Legacy systems used CROs are tedious to configure and add complexity to clinical trials, hence, slowing down the execution. Modern CTMS applications help companies comply with standards, offer comprehensive visibility, and improve clinical outcomes.

Founded in 2007, Veeva is a pioneer in the cloud-based industry. It merges the benefits of advanced cloud-based solutions with regulated industries such as life science and consumer goods. Its solutions enable companies to unify disarticulate processes and data to create premium products faster, without compromising tractability.

Veeva offers integrated solutions with advanced capabilities that enhance clinical trial management, such as the Veeva Vault Clinical Suite. It is the industry’s only cloud platform that incorporates EDC (Electronic Data Capture), CTMS, eTMF (Trial Master File), Study Start-up, and site document exchange into a single, comprehensive suite of clinical cloud solutions 

The Vault Clinical Suite is a flexible, adaptable, and agile program that helps life sciences companies customize clinical trial operations as per their unique needs, study designs, and business ideologies. It eliminates manual study trackers, and organizations can easily configure the system and amend protocols at any stage.

Veeva Systems offers a plethora of products spanning across various subcategories of life sciences, including but not limited to clinical, commercial, industrial, and medical processes. One such exemplary solution that uses advanced technology to its benefit is the Veeva Vault CTMS.

Vault CTMS offers real-time visibility across the entirety of clinical trial processes. By doing so, this exceptional tool enhances functional efficiency, streamlines coordination, and facilitates a speedier trial execution that does not compromise on quality. It is an advanced functional system that is easy to configure, and it facilitates team collaboration and data monitoring.

Vault CTMS was devised, keeping in mind the notion that clinical research teams appreciate user-friendly CTMS solutions that provide a consistent experience throughout the clinical trial process.

This helped develop Vault CTMS into what it is today; a cohesive, reliable, and secure platform that allows organizations to seamlessly coordinate end-to-end trial processes and gain detailed insights into all the tasks and processes involved.

With its simple navigation, accessible interface, and coherent record system, Veeva Vault CTMS offers an array of benefits to clinical research companies. These include:

• Faster trial execution: Vault CTMS has interactive, all-encompassing dashboards that generate real-time, pragmatic insights into the trial status. This enables Clinical Research Organizations (CROs) to quickly identify gaps and delays in the trial process and proactively address them to restore momentum. This refines trial performance and efficacy.

• Strategic decisions: The CTMS solution offers organizations a cohesive view of global operations under a single source. With Vault CTMS, sponsors always have real-time and accurate visibility into their trials, helping them improve and speed up their decision-making process. 

• Streamlined Clinical Operations: Veeva Vault CTMS integrates seamlessly with the Vault Clinical Suite, giving CROs a single, cohesive source of reliable information on start-up content and data. This unified sign-on solution eliminates the complexity of switching between multiple systems to organize clinical data, hence streamlining the trial process.

From site selection and monitoring to organizing data and providing analytical insights into the trial process, Veeva Vault CTMS proves its efficiency. It is the first cloud system built from scratch that can meet the rigorous usability, validation, security, and rapid expansion requirements of life sciences organizations.

Veeva’s Vault CTMS enables users to plan and select the sample groups’ size for research. Sponsors can customize parameters such as screening processes, random sample selection, and enrollment protocols. This automated system gives research teams a comprehensive view of the study group, site, and study country. With these insightful metrics, researchers can adjust enrollment goals to ensure the timely completion of clinical trials.

When it comes to site monitoring, research teams can proactively manage all aspects of routine visits such as pre-study, interim monitoring, and closeout, using Vault CTMS. The cohesive CTMS platform helps CRAs (Clinical Research Associates) setup and implement remote trial monitoring methods to minimize site visits and efficiently resolve site violations.

Teams are granted tools to identify site trends and site adherence to ICH (International Conference on Harmonization) or GCP (Good Clinical Research Practice) protocols right from the CRA homepage without being restricted by location or device. They can also author and update new monitoring reports and view critical metrics from the same application.

The application facilitates seamless and organized planning, based on clinical research stages, such as regulatory protocols, visit frequency, and milestone tracking. The CTMS helps organizations optimize their trial resources and meticulously plan frameworks for different scenarios, such as aligning site visits with clinical supply arrivals or analyzing site performance parameters across related studies.

The innovative CTMS platform also bolsters collaboration between the study team and site personnel, such as sponsors, CROs, and investigators. Everyone involved in the project can track communication logs and assigned resources at any given time. This seamless collaborative approach improves study execution and ensures the timely management of goals without any conflicts.

Research teams can take immediate action right from their dashboard, eliminating redundant processes and increasing efficiency. Teams can easily create reports on the interactive dashboard that show real-time metrics and set different attributes such as country, investigator, portfolio, and activation status. The solution gives teams a clinical master data source, which can be remotely accessed by all team members.

The Veeva Vault CTMS platform also has a risk assessment feature to facilitate allocation based on priority. Clinical study teams can create a risk library based on present or past studies using risk templates. These templates can be reused across multiple studies, and risk scores can be compared based on the parameters of impact, probability, and detectability. This helps teams efficiently prioritize resources and recognize gaps in their study process.

With the ingenious Vault CTMS solution, CROs can leverage trial documentation and data across multiple systems, research sites, and even countries, in a hassle-free manner, without being transferred through systems.

This transparent and unique approach is what gives the solution an edge over its competition. It’s a one-stop source that enhances all-round visibility and control and hence accelerates the recruitment process.

Vault CTMS has a dynamic security system that provides different security clearance levels based on study teams or member roles. Research personnel can only access information pertinent to them, protecting the cohesive system from data breaches and unwarranted risks.

The CTMS application is also integrated with Vault Payments, enabling sponsors to track finances and reimburse site payments quickly and efficiently. Vault CTMS users can also access data from the Vault EDC solution, which offers better visibility and reporting. 

The COVID-19 pandemic impacted several sectors, including the clinical trial industry. With the urgency of the pandemic demanding a vaccine or cure, Veeva took proactive measures to address the need for clinical process innovations that wouldn’t compromise on quality to avoid the delay of clinical trials. 

The company leveraged its Vault EDC system to develop a versatile casebook template for COVID-19 to optimize clinical trials and maintain quality. Using this meta-driven system, the company narrowed down user reviews, testing, and validation across multiple reports and studies, to only what was vital.

Reputed biotechs and global corporations have adopted the Vault CTMS cloud application to manage their clinical trials across several study phases. More than seventy-five companies, including six leading pharmaceutical companies, have shifted to the cloud-based application to organize and accelerate their clinical trial processes.

Vault CTMS is a stellar platform that addresses the myriad scientific, regulatory, and market changes that impact clinical trials. Its cloud solutions break global barriers and unify clinical trials that span across many geographically distinct sites and partners.

The Veeva Vault CTMS solution functions as a single source of information and management across the entire lifecycle of the trial process. It is an innovative platform that simplifies clinical trial processes and enables life sciences corporations to achieve exceptional levels of efficiency and transparency across their clinical trials.