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Challenges Facing the Clinical Trials Industry
The clinical trials industry faces several challenges that impact the efficiency, cost, and overall success of clinical trials. Some of the key challenges include:
Increasing Trial Complexity
Modern clinical trials are becoming more complex, involving larger sample sizes, multiple study sites, intricate protocols, and advanced technologies. Managing and coordinating these complexities pose logistical and operational challenges, which can impact trial timelines and budget.
Rising Costs
Conducting clinical trials is an expensive endeavor. Costs include study design, protocol development, site selection and management, data collection and analysis, regulatory compliance, and more. High costs limit the number of trials that can be conducted and can also lead to higher drug prices.
Regulatory and Ethical Compliance
Clinical trials must comply with rigorous regulations and ethical standards to protect participant rights, safety, and welfare. Meeting these requirements can be time-consuming and resource-intensive, and failure to adhere to regulations can result in delays, penalties, or even trial termination.
Data Management and Analysis
Managing and analyzing the vast amount of data generated in clinical trials can be challenging. Ensuring data integrity, accuracy, and security is crucial. Advanced data management tools and methodologies are needed to handle the complexity of clinical trial data effectively.
Collaboration and Data Sharing
Managing and analyzing the vast amount of data generated in clinical trials can be challenging. Ensuring data integrity, accuracy, and security is crucial. Advanced data management tools and methodologies are needed to handle the complexity of clinical trial data effectively.
Diversity and Generalizability
Ensuring diversity among study participants is vital to generalize trial results to broader populations. However, recruiting a diverse participant pool can be challenging due to factors such as geographic limitations, language barriers, cultural considerations, and disparities in access to healthcare.
Adverse Event Reporting
Prompt and accurate reporting of adverse events is crucial for participant safety and regulatory compliance. However, underreporting or delayed reporting of adverse events can occur, affecting the assessment of the intervention safety profile.
AuroraPrime Products Overview
AuroraPrime is an integrated clinical research platform that covers the entire process of clinical research. AuroraPrime incorporates a suites of products built on top of the platform that can operate independently to address specific issues in the research process, or be combined for better efficiency and data consistency.
All of these modules can be customized to fit each company's unique business processes. Additionally, the data generated on the AuroraPrime platform can be connected to the customer's own data platform, providing a source of clinical data for enterprise data governance.
The AuroraPrime clinical research platform standardizes and optimizes the traditional trial process from start to finish, resulting in a faster trial process.
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We are excited to partner with Yaocheng and their Prime Create product, which offers a comprehensive authoring system for protocol design in clinical research. The system includes content authoring assistance, intelligent content generation, structured content, online team collaboration, historical version management, approval flow, and knowledge retention and application. Prime Create goes beyond standard authoring systems with its intelligent expansion and future capabilities. We are impressed by the detailed, professional, and convenient functions it offers, which will undoubtedly improve the efficiency and quality of medical writing.
CSPC Pharmaceutical Group
Medical Writing and Information Department, CSPC
The integration and user-friendly experience of Prime Collect (EDC) and Prime Control (RTSM) products, along with the timely and professional technical support from the Yaocheng team, left a deep impression on us.
Data Management Director, RemeGen
Our partnership with Yaocheng began with a focus on optimizing the overall workflow and improving writing and collaboration efficiency through an enterprise-level system for document writing. We also aimed to use machine learning and other technologies to understand and extract the contents of current and past documents, enabling the seamless flow of document content and trial data within the system. Ultimately, our goal is to achieve intelligent clinical research document management.
We have our own plans and ideas regarding the digitalization of clinical trials, and we found that Yaocheng's product design and philosophy are highly aligned with the new demands and trends in this industry as we trusted.
Xinan Lu, Ph.D.
Co-founder, CMO
BriSTAR Immunotech is the first client to go live with AuroraPrime, and there is no doubt about the professionalism and fresh user experience this product offers. In particular, the sense of mission and vision we felt from the Yaocheng team during our interactions has shown us a new future for electronic and intelligent management of clinical trials.
Xueqiang Zhao, Ph.D.
Co-founder, CEO
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