Clinical trials play a pivotal role in advancing medical research and bringing new treatments to patients. Traditionally, trials have been conducted using paper-based methods for startup activities and beyond, such as negotiating Confidentiality Disclosure Agreements (CDAs) and managing regulatory processes, but the landscape is rapidly evolving. In recent years, there has been a growing momentum towards digitizing and modernizing clinical trials overall – including electronic documents.
Embracing electronic documents and tools such as the category-defining RealTime-Devana, previously PROPEL, platform can help increase an organization’s efficiency, accuracy, compliance, and more throughout the entire clinical trial process. Devana is a business process improvement platform that touches all things clinical trials – from pipeline management and streamlined study startup through to historical trial metrics – including document management, providing one source of truth for all your clinical trial data that can be easily shared with internal and external shareholders alike.
Why Transition
There are many compelling reasons as to why the clinical trials industry should consider moving away from paper and embracing digital solutions, including:
- Efficiency and Speed: One of the primary advantages of transitioning to digital platforms and electronic documents is the significant improvement in efficiency and speed. Paper-based processes are inherently slow and prone to errors, leading to delays in data collection and analysis. Devana enables real-time data entry, instant updates, automatic alerts and reminders, and streamlined communication among stakeholders, reducing the overall duration of clinical trials.
- Data Accuracy and Quality: Accuracy and quality of data are paramount in clinical trials. Paper-based methods are susceptible to transcription errors, missing data, and inconsistencies. Devana offers built-in validation checks, automated data entry, and centralized databases that enhance the accuracy and integrity of trial data. This not only ensures reliable results but also contributes to more robust regulatory submissions.
- Cost Savings: While there may be initial costs associated with implementing digital solutions, the long-term benefits often outweigh them. Devana eliminates the need for paper storage, duplicate data entry, and extensive monitoring efforts, leading to substantial cost savings over the course of a clinical trial. All trial-related data and files are stored in a single, secure place, saving time and money when it comes to making changes, sharing updates, searching for historical information, and more.
- Regulatory Compliance: The regulatory landscape governing clinical trials is evolving, and regulatory agencies are increasingly recognizing the benefits of digital solutions. When progressing trials through the startup process and beyond, Devana helps to track all regulatory stages, ensuring research site organizations stay prepared for regulatory expectations, contributing to smoother interactions with health authorities.
- Flexibility and Adaptability: Digital platforms provide the flexibility to adapt to evolving trial requirements and protocol changes. Unlike paper, which can be rigid and difficult to modify, Devana allows for quick updates and amendments. This adaptability is crucial in the dynamic landscape of clinical research, where trial protocols may need adjustments based on emerging data or regulatory feedback.
- Scalability: As operations grow and expand, having digitized document management is key. Whether you’re looking to add a new investigator or an entirely new site, onboarding is made faster and easier with agile technology. Devana enables users to securely share documents between stakeholders regardless of their physical location, helps establish standardized processes across different locations for improved efficiency, and allows central teams to monitor real-time activities across all sites.
Make the Leap
The shift from paper to digital in clinical trials represents a transformative leap towards a more efficient, accurate, and adaptable approach to medical research. While challenges and barriers may exist, the benefits of adopting digital solutions like Devana far outweigh the status quo. Embracing the future of clinical trials means embracing technology that can revolutionize the way we bring new therapies to patients, ultimately improving healthcare outcomes for all.
