Edetek’s CONFORM Platform: Streamlining Clinical Data Management in Oncology Trials

Overview of the CONFORM^™ Platform

The CONFORM^™ platform by EDETEK offers a multifaceted approach to managing clinical data, focusing on five core areas:

• Connect: With capabilities to interface with more than 75 data sources, including electronic data capture systems and labs, CONFORM ensures comprehensive data collection.
• Collect: This function aggregates, transforms, and validates data, employing pre-built libraries for oncology and other specialties to ensure data accuracy and compliance with trial standards.
• Conform: Tailors data to fit regulatory standards like SDTM and ADaM, or custom standards, streamlining the process for regulatory submissions.
• Consume: Facilitates real-time clinical data review, crucial for risk management and ensuring patient safety during trials.
• Conduct: Integrates various clinical trial management tools, enhancing the execution phase of research studies.

Oncology-Focused Accelerator: CONFORM^™ – ONCO+

For oncology, which presents unique challenges due to its data complexity, EDETEK introduced CONFORM^™ – ONCO+. This accelerator:

• Reduces Study Onboarding Time: By up to 50% through pre-validated data adapters for a wide range of data sources. It tackles the integration of both structured and unstructured data like medical imaging and genomics.
• Enhances Data Quality: Provides specific oncology data validation and quality management modules, leveraging AI for smarter data handling and analysis, including tools like Chat.IQ for intuitive data querying.
• Real-Time Insights: Offers near real-time data capabilities, demonstrated by case studies where data is reviewed every 20 minutes, allowing for prompt decision-making on patient care and trial progression.

Broader Application and Adoption

While CONFORM^™ – ONCO+ is focused on oncology, the CONFORM™ platform supports a wide array of therapeutic areas, including CNS, rare diseases, and cardiovascular, and is trusted by half of the top pharmaceutical companies and numerous smaller to mid-size entities. This wide adoption underscores its versatility and impact across the clinical research spectrum.

Addressing Industry Challenges

The pharmaceutical industry, particularly oncology research, faces increasing trial complexity, from larger patient pools to more detailed data requirements. CONFORM^™ addresses these by:

• Simplifying Data Integration: Managing the influx of diverse data types efficiently.
• Speeding Up Trial Processes: From patient recruitment to data submission, reducing both time and cost.
• Improving Safety and Compliance: Through real-time monitoring and adherence to regulatory standards.

Conclusion

EDETEK’s CONFORM^™ platform, with its ONCO+ accelerator, represents a significant step forward in clinical data management. It promises not only to manage the current demands of oncology trials but also to adapt to future challenges as the industry evolves. This platform could
serve as a model for how technology can be harnessed to make clinical research more
effective, faster, and safer — benefiting both researchers and patients.

CONFORM^™ platform, with the ONCO+ accelerator, marks a significant advancement in clinical data management, promising to handle current and future oncology research demands, making research more effective, faster, and safer for all involved.