Clinical trial complexity has grown in both size and breadth, from small rare illness studies to massive vaccination trials with tens of thousands of patients. However, not all electronic data capture (EDC) solutions can grow to meet the evolving needs of today's clinical trials.

When clinical trial sponsors reach the capacity limit of their EDC system, they either divide the study execution into smaller, distinct implementations or collaborate with another EDC provider to save the study. Both alternatives drastically interrupt clinical trials and impose extra processes, time, and expenses associated with data aggregation and reconciliation. 

To prevent needless interruption, decrease risk, and make operations as easy as feasible, sponsors and CROs want a scalable EDC system for clinical trials capable of fulfilling the particular objectives of their studies.

Why Is EDC Scalability Important?

Although clinical trials share parts, each research phase may contain distinct characteristics, making scalable EDC in clinical trials a crucial component. For example, phase I first-in-human (FIH) trials may involve just 20 to 80 participants, but many gene therapy studies only treat one person. Later-phase and post-marketing studies, on the other hand, might encompass tens of thousands of patients.

The variety and velocity of data utilized in clinical trials have risen as a result of COVID-19's acceleration of the adoption of decentralized trial models. Data for studies may be collected immediately utilizing eCOA apps or wearables, as well as through on-site patient visits. Clinical trials may also use data from electronic health records (EHR) or biobanks.

Depending on the protocol's complexity, a clinical experiment might quickly create millions of data points. Whether data is submitted into the EDC system via an electronic case report form (eCRF), uploaded from lab or imaging reports, or directly obtained from the patient, the EDC system must adapt and scale to give a full picture of all these data points.

The length of a clinical trial determines the requirement for a strong EDC system that can adjust to mid-study alterations as well as complex procedures and dosage regimens. Oncology, which accounts for approximately 30% of pharmaceutical R&D investment, outpaces all other therapeutic categories in terms of complexity due to protocol revisions and data needs.

According to a study conducted by the Tufts Centre for the Study of Drug Development, Phase I-III cancer studies take 14 to 18 months longer than trials in other therapeutic areas. Oncology programs can take up to 12 years to finish, compared to eight years for other courses. Some oncology studies are even longer since patients are monitored for the remainder of their lives. Trial lengths are increasing as medicines become more effective at extending life. 

Scale-up for Long-term Clinical Trials

As clinical trials become longer, more complex, and involve more data points, the EDC in clinical research must adapt accordingly. It needs to scale up to add additional patient visits, assessments, and data. It must also provide a comprehensive data view, whether those data come from an ePRO app, from diagnostic assessments, or from vital signs taken by a home health nurse. 

Scalability also matters when managing workflows and clinical trial data. User interface and system tasks must remain usable even with high volumes of data streaming through them. In addition, the EDC system needs to use artificial intelligence disciplines like machine learning (AI/ML) to enhance workflows and optimize data management review and data cleaning.

Scaled Down EDC Systems for Precision Medicine and Rare Diseases

When clinical trial data requirements grow more focused, the EDC system must scale down as needed. Smaller organizations doing smaller-scale research may believe they can get by without a specialized EDC system, but this can lead to issues as the investigation advances. Platforms that specialize in simple, quick study constructions, for example, may speed up the launch, but they may not adapt as a study grows. Smaller biotechs and CROs must evaluate the demands of their current trials as well as future trials when selecting an EDC vendor.

How to Scale for the Future With Octalsoft EDC

Because of our robust data management platform, Octalsoft EDC can scale with the trial, which means we can monitor multiple studies in parallel and potentially merge datasets as needed from these studies to support a streamlined development plan, leading to approval when we reach that stage.

Choose an EDC platform with the flexibility and scalability to perform pharma, biopharma, and/or medical device studies, regardless of size, phase, or therapeutic area, as clinical trials become more complicated and large. 

In Summation

An EDC platform cannot scale effectively unless it integrates with RTSM, CTMS, eCOA, eConsent, and other systems. When all of these solutions work together on a single platform, all research data is centralized in one place for maximum flexibility. Users may obtain real-time data for speedy decision-making and mid-study adjustments.

When it comes to monitoring adverse events, a single platform integrated with AI/ML enables clinical monitors and data administrators to detect abnormalities more quickly and simply.

Sponsors and contract research organizations (CROs) conduct studies ranging from very targeted precision medicine assessments to worldwide Phase III-IV trials. Choose an EDC that is scalable and flexible enough to support the whole spectrum of studies as well as any mid-study surprises.

According to the Tufts Centre for the Study of Drug Development (Tufts CSDD) study, at least one protocol change happens in more than half of all clinical trials. These changes have the potential to destabilize locations and research teams, causing inefficiencies. For example, if a change affects how therapy is administered or how and what data is collected, sites may need to re-consent with a patient. Changes in research procedures cause big logistical issues for everyone involved and waste a lot of time, especially when it comes to clinical trial data gathering.

Modern EDC Systems Must Accommodate Protocol Amendments

Data collection and patient visit schedules are disrupted if a protocol amendment necessitates. According to the Tufts CSDD research, clinical trials average 2.2 to 2.3 protocol revisions. This means that electronic data capture in clinical trials may have to be shut down several times, which is both disruptive and wasteful. Given the frequency with which changes occur, EDC systems should be built to sustain regular operations while adapting to changes.

Amendments that codify clinical trial data gathering, on the other hand, must be explicitly indicated for users to ensure that each modification is implemented throughout the study. If a new field is introduced to a form, the user interface should make it apparent that the new field must be filled out. Otherwise, clinical research coordinators may overlook the addition of a new item to their process. These sorts of notifications are straightforward but useful procedures that should be common in EDC systems. A clear approach for training or retraining users on any new feature should be included as part of that infrastructure.

Adaptable Designs, Adaptable EDC

Clinical trial design is becoming increasingly difficult. Adaptive trials, for example, evolve over time, which means that an EDC system must account for every conceivable path the trial may take. There are also several types of trials, such as basket, umbrella, and platform, each of which need a versatile electronic data capture software for clinical trials. As sponsors employ a broader range of complicated clinical trial designs, their EDC systems must be capable of implementing complex changes—often in the middle of a study.

Telehealth consultations quickly became a viable and essential alternative to in-person sessions during the COVID-19 epidemic. Remote visits in clinical trials increased in 2020 and 2021 as a result of site closures, travel limitations, and patients' reluctance to attend a medical center. Data from telemedicine platforms, wearables, sensors, and other sources must be integrated into EDC systems for this decentralized research. They also need the capability and flexibility to support numerous treatment arms as well as the mid-study adjustments that are inherent in adaptive trial designs.

Octalsoft EDC Supports the Next Era of Clinical Data Management

Octalsoft is constantly improving electronic data capture systems to match the flexibility demands of current clinical trials. EDC does not need any downtime for protocol changes. Following implementation, site users are automatically allocated the tasks necessary to accommodate the change, and revised eCRF completion criteria may be published and made instantly accessible, informing site users about the eCRF modifications and what new/changed data are required. Once a modification is made, it may be implemented without disrupting patient site appointments or bringing the entire system down. The ultimate goal: consistent, uninterrupted performance.

For reporting reasons, effective electronic data capture solutions log all modifications so users know when and how they were applied. modifies can also be reversed if, for example, a patient withdraws consent following a protocol modification that modifies what data they must supply. EDC saves users time by automating as many of these procedures as possible, allowing them to focus more on patients and the day-to-day operations of clinical trials.

Although all aspects of a clinical trial are rigorously monitored, studies are becoming increasingly complicated, protocol changes are regular, and recruitment is unpredictable. Furthermore, our environment is continually and rapidly changing, which has a direct influence on both trials and participants. 

There are three core reasons why Octalsoft EDC is a firm favorite for clinical data management, clinical operations, and clinical database programming teams:

1. High Configurability

The majority of EDC studies may be built without the use of special functions. A study's components may be customized in 95% of cases. Octalsoft and our clients both have libraries of reusable custom functions to help them construct new studies faster. Customers can employ EDC's Professional Services team or create their own sophisticated research. Other solutions may need the development of additional functionality by a vendor in order to support a certain protocol.  

2. Flexibility

EDC enables the ability to personalize the study construct and execute any protocol amendment or other mid-study design modification to provide support for any protocol, including complex adaptive designs and master protocols.

3. Transformational Study Build Processes

Octalsoft is dedicated to streamlining operations while maintaining quality and efficacy. By allowing greater study-build customization through the user interface, our next-generation study design technology changes the process. This novel method incorporates complicated casebook dynamic behavior. Because clinical data capture is no longer limited to EDC, we're centralizing the definition of a study across applications, including developing data source agnostic edit checks and data definitions (i.e., the same data definitions and edit checks would apply whether collected via EDC or eCOA).

Many of the edit checks we write now (to account for all eventualities) never run. A recent study at a big pharma customer revealed that anywhere from 45% to 75% of scheduled edit checks were never completed.

Octalsoft is enabling a more intelligent, risk-based approach to building research. As part of our next-generation data platform that supports the progression of clinical data management to clinical data science, we maintain data quality by concentrating edit check development on the most prevalent cases and employing AI/ML to detect data abnormalities. As a result, the amount of custom programming necessary to implement research will be reduced. 

These three fundamental elements result in simplified study builds, which speed up the study construction procedure for many clinical studies.

Conclusion

To meet the clinical trial landscape's complexity and unpredictability, the only logical technology solution is a system with the functionality, adaptability, and flexibility to properly fit with your research. This necessitates the use of a system that is adaptable, can use pre-existing custom functions, and can create new custom functions to meet specific needs. If your EDC lacks them, it will be unable to expand and accommodate the rising number of complex/innovative trials.

This adaptability is one of the primary reasons Octalsoft's EDC has been chosen by over 30,000 users.

Octalsoft's staff collaborates with you to understand your study objectives, study design, and any special requirements. Alternatively, our training experts will assist you in creating your own studies. 

In today's rapidly evolving clinical research landscape, efficient and secure data capture is paramount. Electronic Data Capture (EDC) software has become the backbone of clinical trials, streamlining data collection, management, and analysis. According to a 2024 report by Statista, while the share of office-based U.S. doctors using such systems was around 18 percent in 2001, the uptake stood at some 88 percent in 2021. By 2027, the market value of EHRs is forecasted to reach 47.2 billion U.S. dollars, up from 29 billion U.S. dollars in 2020.

However, with so many alternatives available, you may find deciding on the best EDC difficult. This article digs at outlining the strengths of Octalsoft's EDC system and demonstrating its edge over other options.

Understanding EDC Software:

EDC software acts as a digital repository for clinical trial data, enabling researchers to collect, manage, and analyze data electronically. It facilitates the creation of electronic Case Report Forms (eCRFs), which replace paper forms, promoting data accuracy and reducing errors.  Additionally, EDC software offers features like automated data validation, real-time data monitoring, and robust reporting functionalities. EDC systems have diverse functionalities, which result in their user base being quite extensive. From sponsors to CROS and on to sites, EDC systems are leveraged across functions to streamline modern clinical trial data collection, management, and data-backed strategy formulation.

Based on End-users, the electronic data capture systems market is segmented into CROs, Pharmaceutical & Biotechnology Firms, Hospitals/Healthcare providers, Medical Device Firms, and Others. 

Key Considerations When Choosing EDC Software:

As you can gauge from the report above, it is clear that an EDC system is now a must-have for every clinical trial, regardless of who the end user is. But not every EDC system in the market is capable of handling the requirements of a modern-day clinical trial and therefore you must choose a system with caution and due diligence. Several factors come into play when selecting the best EDC software for your clinical research needs. Here are some crucial aspects to consider:

Scalability and Flexibility: The software should adapt to your study's size and complexity, accommodating diverse research needs.

Compliance and Security: Ensure the software adheres to regulatory requirements like HIPAA and GCP, guaranteeing data integrity and participant privacy.

User-Friendliness and Customization: The platform should be easy for researchers and participants to navigate, offering customization options to fit specific study requirements.

Integration Capabilities: Seamless integration with existing clinical trial management systems (CTMS) and other relevant software is crucial for efficient data transfer and analysis.

Cost and Value: While budget plays a role, consider the long-term value proposition offered by the software. Look beyond the initial cost and evaluate the return on investment (ROI) in terms of time savings, improved data quality, and overall research efficiency.

Why Octalsoft's EDC Stands Out:

With a deep understanding of the current clinical research landscape and a commitment to innovation, Octalsoft's EDC emerges as a leading contender in the market. Here's what sets it apart:

1. Unmatched Scalability and Flexibility:

Octalsoft's EDC is architected to adapt to any study size and complexity. Whether you're conducting a small, single-site trial or a large, multi-national study, the platform effortlessly scales to your needs. Its flexible design allows for the creation of customized eCRFs, catering to diverse clinical trial requirements.

2. Unwavering Commitment to Compliance and Security:

Octalsoft prioritizes data integrity and participant privacy. The platform adheres to the strictest regulatory guidelines, including HIPAA, GCP, and GDPR, ensuring data security and compliance throughout the research process. Robust security features like role-based access control, audit trails, and encryption provide an additional layer of protection.

3. Intuitive User Interface and Streamlined Workflow:

Octalsoft's user-centric design philosophy translates into an intuitive and user-friendly interface. Both researchers and participants can navigate the platform easily, maximizing user adoption and minimizing training needs. The system incorporates pre-built templates and functionalities to streamline data collection and workflow, saving researchers valuable time and resources.

4. Seamless Integration and Interoperability:

Octalsoft's EDC seamlessly integrates with leading CTMS solutions and other relevant software. This fosters efficient data exchange and eliminates the need for manual data entry, minimizing errors and streamlining data analysis processes.

5. Competitive Cost and Proven Value:

Octalsoft offers competitive pricing models, making its EDC solution accessible to a wide range of research organizations. Additionally, the platform's features and functionalities deliver significant value, translating into tangible benefits such as:

Enhanced data accuracy and reduced errors

Streamlined data collection and management processes

Improved data visibility and real-time monitoring capabilities

Reduced regulatory burden and faster trial completion timelines

Beyond the Features: Octalsoft's Commitment to User Success:

6. Capable of including Amendments with zero downtime

Existing EDC software systems are frequently cited as a source of customer dissatisfaction, given the frequency with which they crash anytime there is a change. The contemporary and adaptable data structure of Octalsoft's EDC makes it possible for adjustments to be made with no downtime, removing the necessity to migrate data whenever an amendment is made and preventing end users from being kicked out of the system. This is more than just "no system downtime," it is in fact "no downtime for end users."

7. Maximizing Custom Functions

Every clinical trial is unique and hence requires an EDC that can adapt to the trial's specific requirements. Octalsoft’s EDC tool includes every functionality that a modern clinical trial could possibly need inclusive of a could-native platform and customization opportunities so that your EDC scales in tandem with your objectives.

8. Intuitive and Effective Study Builds

Building out intuitive and effective studies is yet another essential component of efficient EDC tools. The integrated environment of Octalsoft’s EDC offers a simplified study builder functionality that allows users to do so in much shorter time frames without having to hand over control to development execs to convert protocols to code.

9. Enhanced UX

Octalsoft’s EDC user interface is designed to be both modern as well as deeply intuitive so that the user can navigate the system easily without spending hours in training sessions. There are many additional functionalities within our EDC system that make for a stellar UX.

10. Quicker Access to Data

Octalsoft’s EDC offer a quick and clear overview of patient data at all times. With robust data validation checks and automatic calculations, Octalsoft’s EDC allows users to generate compliant, near submission-ready data; thus, facilitating faster submission of study results for regulatory approval.

11. Compliance and Standardization

Octalsoft’s EDC is compliant with regulatory requirements like 21 CFR Part 11 and HIPAA Privacy Act. It also offers users the ability to maintain a complete audit trail of clinical trial data generated. With Octalsoft’s EDC users can protect the confidentiality of subjects while adhering to independent industry standards like CDISC.

Conclusion:

Better features lead to an enhanced user experience and better UX leads to enhanced productivity and efficiency. This in turn results in better data and thus a better study. But our spirit of consistent innovation doesn’t stop with our EDC. As a core component of our eClinical suite Octalsoft's EDC is simply the starting point for revolutionizing clinical data management. 

In an ever-evolving landscape of healthcare and clinical research, innovation is the key to staying ahead. Octalsoft, a renowned name in the world of eClinical software solutions, has embraced this concept and embarked on a journey to redefine its presence in the industry. The unveiling of Octalsoft's new brand identity and website signifies a bold leap forward, reimagining our commitment to delivering top-notch software solutions for clinical research.

Octalsoft's New Look

The rebranding of Octalsoft is more than just a cosmetic change; it represents a deeper commitment to its core values of innovation, excellence, and customer-centricity. The new logo features a modern, dynamic design that symbolizes Octalsoft's forward-looking approach. With its sleek lines and vibrant orange color palette, the logo is a visual representation of the company's dedication to creating innovative eClinical solutions. 

The color orange in the new logo signifies innovative energy, passion, and determination. It represents Octalsoft’s unwavering commitment to delivering exceptional solutions and services to its clients while keeping in lockstep with the pace of technological evolution.

The website, too, has undergone a significant transformation. It is now more user-friendly, and intuitive while continuing to be a comprehensive platform that offers a wealth of information about Octalsoft's products and services. Navigating through the website is an effortless experience, allowing visitors to explore Octalsoft's suite of eClinical solutions and gain valuable insights into our capabilities.

Octalsoft's new website showcases a sleek and modern design that prioritizes user experience, making it effortless for clients, partners, and visitors to explore its comprehensive suite of eClinical solutions and resources. Users can now navigate with ease, accessing valuable insights, case studies, and thought leadership articles that provide a deep understanding of the latest eClinical trends and innovations. The website serves as a hub for staying updated with the evolving eClinical landscape and is also one of the primary touchpoints to engage with Octalsoft’s experts.

The Journey of Transformation

Octalsoft's decision to revamp its brand identity and website was rooted in a desire to enhance the overall user experience for its clients, and to position the company as a market leader with a global footprint. This transformation reflects Octalsoft's unwavering commitment to staying at the forefront of the eClinical software industry.

But, why is Octalsoft considered a market leader in eClinical software solutions?

Innovative Solutions: Octalsoft has always been at the forefront of innovation in the eClinical software space. Our solutions are designed to streamline clinical trial processes, making them more efficient and cost-effective.

Comprehensive Suite: Octalsoft offers a comprehensive suite of eClinical software solutions, including Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), Clinical Trial Management System (CTMS), ePRO, eDOCs, RSDV and LMS among others. This comprehensive approach simplifies trial management for researchers and clinicians.

Customer-Centric Approach: Octalsoft prides itself on its customer-centric approach. We understand that every clinical trial is unique, and work closely with our clients to tailor solutions that meet their specific needs.

Global Presence: Octalsoft's footprint extends across the globe, serving clients in North America, Europe, Asia, and beyond. Our diverse client base reflects the versatility of our eClinical software solutions.

LeaderSpeak

"The launch of our new website and brand identity is a pivotal moment in Octalsoft's journey," said Mr. Hiren Thakkar, MD at Octalsoft. "We have always aimed to be at the forefront of eClinical innovation, and these changes reflect our commitment to being the trusted partner for our clients and partners as they navigate the ever-evolving eClinical landscape."

“Octalsoft invites clients, partners, and eClinical enthusiasts to explore the new website, engage with fresh content, and embark on this exciting journey toward a brighter and more innovative eClinical future.”

The Future of eClinical Software

Octalsoft's revamped brand identity and website serve as a testament to the company's commitment to advancing the field of eClinical software. The healthcare and clinical research industry is constantly evolving, and the demand for robust, user-friendly solutions is on the rise.

Octalsoft is not merely keeping pace with these changes; we are setting the bar higher. With our new look, we are ready to embark on an exciting journey that will redefine the eClinical software landscape.

In Conclusion

Octalsoft's rebranding and website transformation are more than just cosmetic changes; they represent a renewed commitment to excellence, innovation, and customer satisfaction. 

Electronic Data Capture Software Market: Classification, Opportunities, Types and Applications, Status and Forecast to 2023

Report Details

An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical…