The Impact of a (Less) Specialized EDC System on Oncological Research

International collaboration in oncological research comes with its own set of challenges. Different laws and regulations per country and the complexity of data management across multiple sites can cause delays. These delays not only result in higher costs but also postpone potentially life-saving treatments for patients.

The Challenges of Oncological Studies in Numbers

• More Complex Protocols

Phase 3 oncology protocols are on average 16% longer than other drug studies and require significantly more revision cycles: 9.7 versus 5.9.
(Source: Tufts CSDD, 2021)

• More Amendments

Phase 2 and 3 oncology studies generate 65% more substantial amendments than other studies: 4.3 versus 2.4 for phase 2 and 4.6 versus 3.0 for phase 3.
(Source: Tufts CSDD, 2021)

• Longer Timelines Than Planned

Multicenter oncological studies require on average 30% more time to complete than originally planned—while time is especially critical in cancer research. Accelerating research can literally save lives.

• Unique Challenges

Oncological studies require repeated treatment cycles, unforeseen visits, and frequent adjustments to dosage schedules. This emphasizes the need for flexible and efficient research systems.

The Clinical Research Suite by ResearchManager is Suitable for Oncological Studies

1. Supports the Complete Clinical Trial Journey

Our platform seamlessly aligns with all stages of the clinical trial journey: from the recruitment phase, to the enroll phase, to the engage phase. In this way, our clinical research suite provides end-to-end support throughout the entire oncological research process.

2. The Clinical Research Suite Includes All Essential Modules

An integrated system connection provides a centralized overview of all study activities. This real-time monitoring allows study coordinators to instantly see recruitment progress across sites, identify protocol deviations, and spot data trends requiring immediate attention.

Fully Compliant

In addition, the Clinical Research Suite is fully compliant with international standards such as GCP, 21 CFR Part 11, and GDPR. This reduces regulatory barriers across countries.

Clinical Data Management

• EDC – Collecting patient data
• eSource – Direct data capture via APIs
• RTSM – Randomization and medication management
• Visit Planning – Efficient scheduling of visits

Patient Engagement

• ePRO – Digital questionnaires for patients
• eConsent – Digital signatures
• Patient Recruitment – Participant enrollment

Clinical Operations

• CTMS – Central study management
• eTMF – Digital document management across sites

• LIMS – Lab and biobank data management

• RIMS – Regulatory compliance

3. Designed to Handle Oncological Complexity

Our platform is built to manage and streamline the complexity of oncological studies. It equips researchers with the tools to produce reliable results—while remaining easy to use.

As a result, research teams can process complex data and protocol changes more easily and accelerate discoveries that lead to improved cancer care.

• Implement Mid-Study Protocol Changes Without Halting Data Collection

Unlike typical studies with rigid schedules, oncology research requires flexibility due to side effects, disease progression, dose adjustments, and additional diagnostics. Our EDC system accommodates this with flexible visit schedules, dynamic forms, and intelligent validations that handle deviations from standard timelines. When protocols change, updates are immediately and consistently implemented across all sites—without interrupting data collection.

• Set Custom RECIST Criteria (Response Evaluation Criteria in Solid Tumors)

Measure, document, and calculate how well cancer patients respond to treatment by setting your own criteria for Complete Response (CR), Partial Response (PR), Progressive Disease (PD), and Stable Disease (SD).

• Monitor and Manage Lab Data in Detail

Easily add varying reference values per lab—especially relevant in international multicenter studies—as well as factors such as patient demographics (age, sex, etc.), testing methods, and equipment used.

• Automatic Validation Checks for Oncological Datasets

Validation checks reduce errors and improve data quality. ResearchManager’s EDC supports oncology-specific checks such as tumor response, consistency checks, toxicity validations, lab thresholds, treatment cycle validations, and cross-form checks.

• eISF Functionality Offers Oversight of Document Management Across All Sites

The eISF (electronic Investigator Site Files) functionality in our eTMF simplifies administration for multicenter studies.
Study coordinators can instantly see which sites need to take action, while research locations have secure access to only their own documentation.
Thanks to real-time synchronization with the central eTMF and intelligent version control, everyone works with the correct documents at all times. Fully digital approval processes with customizable workflows streamline operations, and all communication is stored within the system for optimal traceability.

Conclusion: Avoid Delays with a System Built for Oncological Research

The Clinical Research Suite by ResearchManager provides a solution for the complexity of oncological research.
By supporting both local flexibility and global standardization, and enabling mid-study modifications without delays, research teams can focus on developing life-saving cancer treatments.

Questions? Our Consultants Have the Answers

Want to learn more about using our Clinical Research Suite for an oncology study? Our consultants are happy to explore the possibilities with you.

Disclaimer
This article is based on the capabilities of ResearchManager’s Clinical Research Suite and published challenges in international oncological research as reported by Tufts CSDD and other industry sources. Specific implementations and outcomes may vary depending on the context and requirements of individual studies.