goBalto Files IPO Prospectus to Accelerate Drug Development with Cloud-Based Clinical Trial Solutions

In the process of treating patients, both medication and time are invaluable; early treatment can lead to rapid recovery and even save precious lives. In the drug development process, is your company still using Microsoft Excel and email to manage task progress? Are you still manually entering clinical trial data? Currently, intelligence, comprehensiveness, and standardization have become the standard tone of global production. How to complete the drug research and development process faster, more efficiently, and accurately on this basis is a new problem and challenge currently faced. The use of new software and IT technology has gradually become an important factor in improving the efficiency of new drug research and development.

A study by San Francisco-based goBalto, involving 82 trial sites, revealed that it takes an average of 17 months to fully activate a site from the start of clinical trials, with monthly costs of at least $1,500. This indicates that activating a single trial site requires a minimum investment of $25,000. Consequently, the total pre-activation costs for all 82 sites amounted to $2 million.

How can research time and costs be saved? There are mainly five methods: 1. Optimization of the research process; 2. Collaboration with research teams to enable real-time research processes; 3. Exchange of documentation; 4. Real-time tracking of the research process; 5. Use of reliable research data. Based on these five methods, goBalto has developed a cloud-based platform solution for tracking and sharing clinical trial processes, which accelerates study startup, ensures continuous document synchronization, facilitates real-time collaboration and document exchange, provides visibility into files and opinions, and keeps all participants informed of the current status of the study.

The company’s products streamline and accelerate clinical research in the pharmaceutical, biotechnology, and medical device industries. The company is committed to enabling all stakeholders to monitor trial progress in real time and track clinical trials during drug development, while contract research organizations (CROs) can visualize trial processes in real time, thereby accelerating the completion of clinical studies. Currently, the company’s products are used by Amgen, Genentech, IQVIA, Johnson & Johnson, and Roche.



 

goBalto Product Line

goBalto currently has two products: Activate and Analyze.
At project initiation, using Activate provides access to extensive web resources, research status across various countries, study documents, and diverse activities, which users can leverage for subsequent reporting and analysis. Meanwhile, the software enables sharing of study documents and data with other partners, ensuring clarity on required tasks for all stakeholders, thereby replacing conventional manual Excel reports.
Activate has the following features: 1. Customizable workflows that enable task completion in accordance with different companies’ standard operating procedures (SOPs) and best practices; team members receive reminders to complete assigned tasks, while the software automatically tracks individual completion times. 2. Simplifies, automates, and standardizes multiple processes. 3. Manages key milestones at all levels. 4. Improves quality and reduces cycle time by 66%. 5. Establishes regulatory and standards-compliant processes that integrate with the company’s CTMS and eTMF systems.
Specific functions are as follows:
1. Employee turnover increases departmental costs; Activate intelligent workflows enable new hires to quickly familiarize themselves with job responsibilities and achieve competency in the shortest possible time.
2. Facilitate collaboration among sponsors, contract research organizations, and sites
Invite websites and Activate to collaborate: exchange documents, communicate, complete tasks, and monitor progress. Everyone can view the documents, opinion papers, and submission status.
3. Reports and time-cycle milestones provide a reference basis for accelerating project initiation
Activate logs the start and completion status of each task, eliminating the need for manual compilation of status reports.
4. Establish the entire eClinical workflow
Activate is neither an eTMF nor a CTMS; it serves as a complementary solution.
Existing eTMF (Electronic Trial Master File) systems serve as repositories for documents. Activate can store files that users are currently processing. Leveraging Activate’s integration toolkit, completed files can be automatically transferred to the eTMF repositories of users and their partners, and systematically organized into folders aligned with the TMF Reference Model. Furthermore, Activate can integrate with market-leading CTMS (Clinical Trial Management Systems) and eTMF vendors.
5. Enterprise-Grade Hosts and Monitoring
Activate and Analyze products are developed based on world-class cloud data center certification bodies.





In the later stages of the process, using Analyze provides access to a broader suite of tools that help monitor progress, automatically identify issues or bottlenecks, and resolve them. Analyze enables team members and partners to leverage data effectively, run ad-hoc reports, and create visualizations of multi-trial data. Users can identify risks and then drill down into details, supported by comprehensive information such as document and submission status, milestone status, task duration, phases, indicators, countries, sites, and team members. Additionally, users can customize their own data. Two standard templates are provided for rapid report generation, allowing easy customization of visualization styles, such as bar charts or line charts. Reports can then be shared with the team and individual members.
Summary: Analyze has the following features: 1. Customizable data formats. 2. Share standard or customized reports with team members or partners. 3. Add custom report libraries.



goBalto User Group
The company primarily provides solutions for the following three types of users: 1. Pharmaceutical manufacturers, medical device manufacturers, biotechnology companies, and other enterprises. 2. Contract Research Organizations (CROs). 3. Clinical trial sites.
1. Pharmaceutical manufacturers, medical device manufacturers, biotechnology companies, and other enterprises can leverage GoBalto to implement automated, intelligent, and customized workflows that guide teams in managing documents and submitting materials, thereby enhancing efficiency. Additionally, its oversight capabilities enable every team member to share real-time research status and track product development progress, thus optimizing processes.
By leveraging goBalto, the company can achieve local management with global tracking, monitor key milestones and research activities, and maintain a holistic view of the entire process.
2. Pharmaceutical R&D contract research organizations (CROs) can use goBalto to share files and data with vendors and trial sites, standardize and automate workflows, and establish compliant regulatory processes. The product is also compatible with the organization’s CTMS and eTMF systems.
3. The use of the goBalto product at trial sites can remind site personnel to send documents or experimental results to manufacturers and service organizations, ensuring real-time communication and smooth interaction.

goBalto's Financing Status
Since its inception, the company has completed five rounds of financing. Since September 2011, it has raised a total of $37.6 million from investors including Aberdare Ventures, Dolby Family Ventures, EDBI, Mitsui Global Investment, Qualcomm Life Fund, and Westhealth Investment Fund. The most recent round was a $12.1 million Series C financing closed on January 6, 2015. Meanwhile, goBalto was named one of the Top 10 Biotech Solutions of 2013 by FierceBiotechIT, selected as one of the Top 100 in the Red Herring North America competition, and received the Special Award for Clinical Trial Partnerships. FierceBiotechIT stated that “goBalto combines the best of high-tech and biotechnology to address significant challenges in the healthcare sector.”



goBalto Founders and Team
Our team is composed entirely of elite professionals, including software engineers and clinical operations specialists from leading organizations such as Amgen, Genentech, IQVIA, Roche, Johnson & Johnson, McKinsey & Company, and Cisco Systems.

Founder and Chairman: Jae Chung


In October 2008, Jae Chung founded goBalto. The origin of the name is rooted in a true story. In 1925, a diphtheria outbreak struck Nome, a village in Alaska. During that harsh winter, the only way to deliver antitoxin to the village was via a dog sled team. The sled dogs became the final link in the antitoxin delivery chain; transporting the life-saving serum from Anchorage to Nome, they saved the entire village. The lead Siberian Husky was named Balto. The name “goBalto” embodies the company’s mission: to spare no effort in accelerating the drug development process and delivering vital medications to patients as quickly as possible.
Jae Chung describes himself as a “geek” and an Apple enthusiast, with a passion for New Order and 1980s rock music. He holds an MBA from New York University and is a Certified Public Accountant (CPA). A visionary entrepreneur, he has served as a startup mentor at the Rock Health accelerator, founded the leading biopharmaceutical company Celltrion, and worked as a strategy consultant at McKinsey & Company. At goBalto, Jae Chung delivers aesthetically pleasing and user-friendly application experiences. He believes that cloud-based workflow solutions can significantly accelerate clinical trial progress, enabling earlier product development. In 2013, he was named one of the Top 10 Tech Executives by FierceBiotechIT, and in 2010, he received the Innovation Award in the Bio-IT community.

CEO:Sujay Jadhav


Sujay Jadhav boasts over 20 years of extensive experience in the leading Silicon Valley software provision industry, with a consistent focus on the life sciences sector. He previously served as Senior Vice President of Global Corporate Strategy and Development at Model N, where he held multiple responsibilities, overseeing corporate development, life sciences analytics, and software-as-a-service (SaaS) operations. Under his exceptional leadership, the company grew from an initial team of six employees to 600, achieved annual revenues of $100 million, and successfully completed its initial public offering (IPO). He holds a bachelor’s degree from the University of South Australia and an MBA from Harvard University.

(Editor: Zhang Nan)

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