The globalization and decentralization of clinical trials have introduced complexities in data collection, management, and regulatory compliance. Ensuring that data from diverse regions and decentralized setups meet FDA standards is crucial for the approval and success of new medical interventions.
Regional disparities in clinical trial data pose significant challenges to the generalizability of research findings and equitable healthcare delivery. Contract Research Organizations (CROs) play a pivotal role in managing decentralized clinical trials (DCTs), which have become increasingly prevalent. The U.S. Food and Drug Administration (FDA) has provided guidance to ensure that data collected from decentralized and international sources meet regulatory standards. NewgenONE's AI-first, low-code platform, integrating Enterprise Content Management (ECM), Business Process Management (BPM), and Customer Communication Management (CCM), can assist pharmaceutical and life sciences companies, particularly Phase 3 (P3) firms, and CROs in aligning with these regulatory requirements.
CROs are instrumental in executing clinical trials, especially in decentralized models where trial activities occur outside traditional clinical sites. The FDA permits sponsors to delegate trial responsibilities to CROs, including the implementation, oversight, and monitoring of DCTs . This delegation allows for flexibility but also necessitates stringent oversight to maintain data integrity and compliance.
The FDA's guidance on conducting clinical trials with decentralized elements emphasizes that such trials are subject to the same regulatory requirements as traditional trials. Key points include but not limited to:
For data collected outside the U.S., the FDA requires that foreign clinical studies be conducted in accordance with GCP and that the data be applicable to the U.S. population and medical practice.
Decentralized trials, while offering increased accessibility and participant diversity, present challenges:
These challenges underscore the need for comprehensive platforms that can manage complex trial processes and data flows.
For P3 – Pharma and Life Sciences companies and CROs, NewgenONE's platform streamlines trial processes, ensures regulatory compliance, and facilitates efficient data management across decentralized and international sites.
NewgenONE offers an AI-first, low-code platform that integrates ECM, BPM, and CCM, providing a unified solution for managing clinical trials:
The evolving landscape of clinical trials, marked by decentralization and globalization, necessitates robust systems to manage complexities and ensure compliance. CROs play a critical role in this ecosystem, and adherence to FDA regulations is paramount. Platforms like NewgenONE provide the technological infrastructure to navigate these challenges, offering integrated solutions that enhance efficiency, compliance, and data integrity in clinical trials.
GHIT Digital ( https://ghit.digital/) is a domain focused, future ready, Enterprise Software Product Implementation, 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 Implementation, Integration, Migration, & Optimization of AI Powered, LowCode NewgenOne EDM, BPM, CCM, ANG and PLM Software Products & Platforms.
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
https://ghit.digital I Monika@GHIT.digital
Government | Health | Insurance | Tech
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