Current Technology Gap

Despite the advancements in clinical trial management technology, several challenges persist. One of the main issues is the lack of a comprehensive resource that covers the entire lifecycle of a clinical trial. This leaves gaps in the understanding of the process, potentially leading to errors or delays. Furthermore, existing solutions may not always be up-to-date with the latest global regulations on clinical trials, which can result in non-compliance and additional costs. Another significant problem is the lack of clear communication and coordination between all stakeholders involved in the trial. This can lead to inefficiencies and miscommunications, which can negatively impact the overall success of the trial. Lastly, existing solutions do not adequately address the unique needs and activities of patients, which can significantly impact their participation and retention in the trial.

 

 

Critical Path Clinical's Solution
First in Class AI enabled E2E clinical trial lifecycle application developed using a digital platform integration approach. The manual is designed to be user-friendly and accessible to all stakeholders involved in the trial, including researchers, clinicians, regulatory authorities, and patients. ​

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Development of the Comprehensive Manual

 Critical Path Clinical Connect is driven by forward thinking innovations aimed to accelerate quality, safe trial delivery for patients through a pioneering platform that serves as a Clinical Trial in a Box. The pioneering platform integrates all stakeholders and functional roles into a clinical trial phase driven approach providing a birds eye view of the E2E Clinical Trial Lifecyle.

Digital Platform Integration

The E2E Work Breakdown Structure is fully functional allowing for  guided clinical trial delivery  using a digital platform integration approach. The manual is designed to be user-friendly and accessible to all stakeholders involved in the trial, including researchers, clinicians, regulatory authorities, and patients.
 

The immersive, digital E2E lifecycle solution is developed using a foundation of regulatory guidelines that cover the entire lifecycle of a clinical trial, from concept, initiation to completion and submission. Information on each stage of the clinical trial process, including patient activities, regulatory compliance, and best practices are embedded for live sources including regulatory guidance. Digital documents allow for site facing and patient centric community portal available on mobile apps!

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The manual is integrated into an AI powered, digital platform, which allows the live embeds of regulatory guidelines to update along with the source requiring little maintenance. The digital platform is hosted on a secure server with appropriate firewalls and encryption measures to ensure the security of the data.

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Training and Support 
Training and coaching programs are developed to support the implementation of the manual. These programs are designed to equip all stakeholders involved in the trial with the knowledge and skills needed to effectively participate in the trial process. 

Patient-Centric Approach: 
The manual also takes into account the unique needs and activities of patients, providing guidance on how to involve and retain patients in the trial. This includes providing clear instructions on how to obtain informed consent, how to communicate with patients about the trial, and how to ensure patient privacy and confidentiality. 
 

Accelerate, Quality, Safe and Cost Efficient Trials for the Patients

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