Insight

One Stop CRO R&D Software Solutions for Pharma and Biotech Companies: Leveraging NewgenOne Marvin

The pharmaceutical and biotech industries are renowned for their complex and multi-layered R&D processes, extending from the initial stages of drug discovery through the various phases of clinical trials and culminating in regulatory filings with agencies such as the FDA. Efficiently navigating this intricate landscape necessitates robust and integrated software solutions. Enter NewgenOne Marvin, an AI-powered, LowCode Enterprise Software Platform designed to revolutionize R&D workflows through its advanced Enterprise Document Management (EDM), Enterprise Content Management (ECM), and Business Process Management (BPM) capabilities.

Enhancing Drug Discovery

Drug discovery is the initial and arguably the most critical phase in pharmaceutical R&D. It encompasses identifying potential drug candidates, synthesizing new compounds, and conducting preliminary tests to assess their biological activity. This phase is characterized by extensive data generation and necessitates meticulous documentation and analysis.

Key Workflows in Drug Discovery:

Target Identification and Validation: Understanding the biological target and confirming its role in the disease.

• Lead Compound Identification: Screening and identifying compounds that interact with the target.
• Lead Optimization: Refining lead compounds to improve their efficacy and reduce toxicity.
• Preclinical Testing: Conducting lab and animal studies to gather safety and efficacy data.

How NewgenOne Marvin Supports Drug Discovery:

• Automated Data Capture and Management: NewgenOne Marvin’s EDM and ECM capabilities facilitate seamless capture, storage, and retrieval of the vast amounts of data generated during drug discovery, ensuring all data is organized, easily accessible, and secure.
• AI-Powered Analysis: The platform's AI tools analyze complex datasets to identify patterns and potential drug candidates more rapidly than traditional methods.
• Collaboration Tools: Integrated collaboration features allow researchers across different departments or geographical locations to work together in real-time, enhancing communication and efficiency.
• Regulatory Compliance: Built-in compliance checks ensure all documentation adheres to regulatory standards, streamlining the process for future FDA filings.

Streamlining Clinical Trials

Clinical trials are structured into multiple phases (I-IV) and are essential for assessing the safety and efficacy of new drugs in humans. Each phase involves detailed planning, patient recruitment, data collection, and regulatory reporting.

Key Workflows in Clinical Trials:

Study Design and Planning: Developing protocols and securing necessary approvals.

Patient Recruitment and Enrollment: Identifying and enrolling suitable candidates for the trial.

Data Collection and Monitoring: Systematically recording patient data and monitoring for adverse effects.

Data Analysis and Reporting: Analyzing collected data to determine the drug’s safety and efficacy, and preparing reports for regulatory submission.

How NewgenOne Marvin Supports Clinical Trials:

• BPM for Process Optimization: NewgenOne Marvin’s BPM capabilities automate and streamline trial management processes, from planning to execution, reducing delays and human errors.
• Real-Time Monitoring and Reporting: The platform offers real-time monitoring tools that allow continuous oversight of trial progress and immediate detection of any deviations or issues.
• Patient Data Management: Comprehensive ECM features ensure patient data is securely stored and easily accessible, facilitating efficient data analysis and reporting.
• Regulatory Documentation: Automated document management and generation tools help in preparing and managing the extensive regulatory documentation required for FDA submissions.

Simplifying Regulatory Filings with the FDA

Regulatory filings are the final step in the R&D process, where comprehensive data from preclinical and clinical studies is submitted to regulatory bodies for approval. This phase is documentation-intensive and requires meticulous attention to detail.

Key Workflows in Regulatory Filings:

Compilation of Data: Gathering all necessary data from discovery and clinical phases.

Document Preparation: Creating detailed reports and submissions as per regulatory guidelines.

Submission Management: Coordinating with regulatory bodies and managing submission timelines.

Post-Submission Monitoring: Responding to queries and providing additional information as required.

How NewgenOne Marvin Supports Regulatory Filings:

1. Centralized Document Repository: NewgenOne Marvin’s ECM provides a centralized repository for all regulatory documents, ensuring that all required information is available and organized.
2. Template Management: Pre-built templates for regulatory submissions can be customized, ensuring all documents adhere to FDA standards.
3. Workflow Automation: Automated workflows ensure all steps in the filing process are completed efficiently, with notifications and alerts to keep teams on track.
4. Audit Trails: Comprehensive audit trails and version control features ensure all changes to documents are tracked and documented, enhancing transparency and compliance.

Conclusion

In the highly competitive and regulated pharmaceutical and biotech industries, the ability to efficiently manage complex R&D workflows is crucial. NewgenOne Marvin, with its AI-powered, LowCode capabilities, offers an integrated solution that supports every stage of the drug development process—from discovery through clinical trials to regulatory filings. By leveraging its advanced EDM, ECM, and BPM functionalities, CROs, pharma, and life sciences companies can enhance their R&D efficiency, ensure regulatory compliance, and accelerate the time-to-market for new drugs. Embracing such innovative software solutions is not just a strategic advantage but a necessity in today’s fast-paced and ever-evolving industry landscape.

About GHIT Digital

GHIT Digital ( https://ghit.digital/) is a domain focused, future ready, boutique IT Services & Digital Transformation firm. We are Minority and Women Owned (MWOB) small business from New Jersey, USA. Diversity, Inclusion, and Growth is our Mantra. Team GHIT works on strategic IT Projects for Government (G); HealthCare (H); Insurance (I); and Technology (T) clients, thus the brand GHIT. We are nimble, scalable and sell & deliver with Platform Partners & Delivery Partners. Our niche capabilities include Agile Project Management, Infrastructure Services, Data Services, Cloud native Data and Apps Implementation, Integration, Migration, Security & Optimization.

Contact US

MonMass, Inc. (the legal name of GHIT Digital) will work on your strategic IT Projects or Consulting requirements (NAICS codes 541511 / 541512 / 541330 / 541618). Feel free to call 201.792.8924 or 646.734.6482 or write to me at Monika@GHIT.digital for no obligation discovery conversation. You are welcome to share your RFPs/RPQs for us to review and respond on time.

Monika Vashishtha, MBA, ITIL, PMP

President & COO 

https://ghit.digital I Monika@GHIT.digita