Strengthen IT Infrastructure – Electronic Submission:

·         Monitor and Improve Usability: Enhance the Electronic Submission Gateway (ESG) and other submission platforms by optimizing structured data ingestion and refining Enterprise Identity, Credential, and Access Management (ICAM) processes to ensure secure and efficient access.

Iyka has direct experience with the Electronic Submissions Gateway (ESG) program under Contract# HHSF223201610014C (TTIyka LLC, DUNS: 079208464). This contract supports the CDER Electronic Submissions Processing (ESP) Program.

Our technical team successfully completed a technology upgrade to the FDA’s electronic submissions backend data extraction and validation system, achieving a 300% increase in processing performance. The upgrade also provided support for the next version of the Commercial-Off-The-Shelf (COTS) tool, addressing Module 1 requirements. This includes processing grouped submissions, cross-referencing information, and managing both promotional and non-promotional materials. Additionally, we implemented coded attributes to reduce the need for frequent updates to the eCTD Comprehensive Table of Contents (TOC), Document Type Definition (DTD), and stylesheets when changes are required.

Additional Expertise in Data Management:

• Data Discovery and Collection: Iyka’s advanced data discovery and collection tools significantly enhance the efficiency and accuracy of structured data ingestion, streamlining the submission process to ensure accurate data capture and processing.
• APIs and Data Enclaves: We provide robust API solutions and secure data enclaves that facilitate seamless data integration, improving the functionality and usability of submission platforms.
• Application Development: Our expertise in application development enables us to modernize and enhance FDA’s submission platforms, ensuring they can manage complex data requirements and processes with ease.
• IT Consulting Services: We offer comprehensive IT consulting services, including system assessments and tailored recommendations to optimize the performance of the ESG and other submission platforms.

Zero Trust

Implement Zero Trust Approach: Strengthen the security of the FDA’s digital environment by adopting a Zero Trust model. This approach ensures continuous verification of users and devices, coupled with granular access control, to safeguard sensitive data and systems.

Expertise in Security:

• Privacy-Preserving Record Linkage (PPRL): Iyka’s PPRL solutions ensure that sensitive data is securely managed, maintaining privacy while facilitating necessary data linkage.
• Secure Information Management: Our comprehensive approach to secure information management supports the Zero Trust model by verifying and securing all access points and data transactions, ensuring robust protection.

Relevant Services:

• Infrastructure Products: We offer a suite of infrastructure solutions, including next-generation firewalls and multi-factor authentication systems, essential for implementing a Zero Trust approach.
• Cybersecurity Expertise: Iyka’s cybersecurity services, such as threat detection and response, align with the Zero Trust model by providing continuous monitoring and security enhancements to protect against evolving threats.

Enterprise Data Services

FDA’s Goal:

Improve Data Visibility, Accessibility, and Governance: Enhance data infrastructure using modern cloud-based technologies and ensure secure and efficient data sharing to support informed decision-making and mission outcomes.

Our Unified Direct Data Platform Services:

• Incorta Data Discovery Platform: Iyka specializes in the Incorta Data Discovery Platform, enabling efficient identification and retrieval of relevant data. This enhances visibility and accessibility across the FDA’s systems.
• Data Enclaves: We excel in developing and managing data enclaves that support secure data sharing and governance, aligning with the FDA’s objectives for data security and collaborative analysis.
• Dashboards: We create advanced, intuitive dashboards that provide comprehensive insights and facilitate data-driven decision-making, supporting the FDA’s goal of improving data accessibility and utility.

Relevant Projects:

• Past Performance: Iyka’s successful execution of data-related projects, such as Electronic Submission Support for HHS and the Integrated HIV Prevention Programs for CDC, demonstrates our ability to enhance data infrastructure and management.
• Joint Ventures with NTIS: Our collaboration with NTIS, involving proposals valued at over $6.8 million, highlights our capacity to deliver large-scale data solutions and reinforces our role as a strategic partner in advancing data services.

Adopt AI and Mission-Driven Innovations

AI Executive Order (E.O.) Implementation & Governance

Iyka’s Expertise in AI/ML:

• Health IT Solutions: Iyka’s experience in health IT solutions and advanced analytics includes integrating AI/ML technologies. This aligns with the FDA’s goals for developing responsible AI practices. Our expertise ensures that AI technologies are deployed to enhance public health outcomes while adhering to ethical standards.
• Advanced Analytics: We utilize advanced analytics to support AI-driven insights and decision-making, which is essential for effective AI governance and implementation.

Relevant Services:

• AI/ML and Analytics Services: Iyka offers comprehensive AI/ML services that facilitate the effective deployment and governance of AI technologies. Our services include developing AI models, implementing machine learning algorithms, and ensuring compliance with regulatory standards.

Emerging Technologies

Experiment with Emerging Technologies: Explore and utilize new and emerging technologies to drive innovation and address public health threats effectively.

Iyka’s Innovation Focus:

• Commitment to Innovation: Iyka is dedicated to exploring and integrating emerging technologies, aligning with the FDA’s objective of driving innovation. Our work with cutting-edge technologies positions us as a valuable partner in enhancing regulatory processes and public health responses.
• Advanced Technologies Experience: Our expertise in cloud computing, data analytics, and AI/ML enables us to support the FDA’s efforts in leveraging novel technologies to tackle evolving public health challenges.

Customized IT services and IT services-based solutions that involves work spread over NAICS 541511, 541512, 541513, and 541519.

Supported FDA’s Electronic Submissions Program (ESP) which receives and routes for processing applications for Drug and Biologic product approvals. Implement standard processes for Regulated Product Submission (RPS), a Health Level Seven (HL7) standard. Define requirements by verifying, validating, and updating requirements for a COTS submission validation tool, incorporating the HL7 RPS Release 2 requirements. Integrated, tested and deployed multiple versions (2010 & 2014) of the COTS Global Submit Validation tool (which enables e-submission validation and viewing), the underlying Oracle Database, and the Reviewer Tool in support of greater than 3000 FDA users. Rewrote major components of the ASR integration code, eliminating 100% of the existing system hangs and reducing monthly trouble tickets by 90%. Perform O&M (including many system enhancements) as well as Tier 1, 2, and 3 “Help Desk” support for users. Support the submission, processing, and evaluation of over 500,000 re-submissions annually.

Major Accomplishments:

The quality of our workmanship and timely completion of deliverables have resulted in the award of multiple, repeat contracts to Iyka for this project. This is substantiation to our focus on doing what is best for the customer in addition to evidence of the quality of our delivery.

The Iyka Team led the technical advisory, troubleshooting, and enhancement of COTS vendor tools for CDER and CBER, ensuring successful implementation for over 3,000 FDA users (primarily in CDER, CBER, and ORA). The team conducted an impact analysis of ASR, recommending and implementing multi-threaded processing, improved database management, and reporting, boosting system performance by over 300%.

Iyka verified, validated, and updated IT requirements to align FDA’s eCTD validation and viewer COTS tools with HL7 RPS Release 2 (eCTD v.4.0). These requirements supported the acquisition and deployment of a new COTS product for processing electronic submissions (IND, NDA, BLA, ANDA, DMF) and facilitating FDA reviewers’ regulatory tasks. The team also upgraded the ASR system and enhanced the next COTS version to process grouped submissions, cross-referenced data, and promotional/non-promotional materials while leveraging coded attributes to minimize updates to the eCTD TOC, DTD, and style sheets.

● Provided services: Need determination to Creating a Governance and Application Rationalization sustainability framework to take in to account: Application lifecycle (including procurement); To-Be-Introduced technologies such as cloud-based applications and mobile applications; Exception processing, communication and management; Must also be able to serve M&A work.

● Goes beyond governance, regulations, and polices and to facilitate evolving CIO practices and provide consulting in the areas influencing.

Iyka Team has provided CPS:

● E-Rate data switch and file server maintenance

● Desktop and server maintenance

● Lan/wan management

● Project c.l.e.a.r. (cps laptop, e-mail, and antivirus rollout)

● Lan system improvement project

● Email and web filtering project

● Network maintenance & monitoring solution

● Master equipment purchase agreement