Managing a clinical trial is a complex endeavor that requires meticulous attention to detail. With diCELLa CTMS, you'll gain access to a comprehensive management panel, empowering you to efficiently oversee your clinical trial.

Our CTMS software offers an array of essential features tailored to meet your needs, ensuring seamless trial management.

Key Features:

• Recruitment Progress Analysis: diCELLa CTMS provides in-depth analysis of recruitment progress, allowing you to track the enrollment of study participants and make informed decisions to optimize the process.
• Site Monitoring Planning: Our software facilitates the planning and execution of monitoring visits according to your predefined templates. This ensures that monitoring activities are conducted consistently and in compliance with your study requirements.
• eCRF Data Filling and Approval Analysis: Efficiently manage the process of data entry and approval in electronic Case Report Forms (eCRF). diCELLa CTMS offers tools for monitoring and analyzing the progress of data collection and verification.
• Contract and Procedure Preparation: Simplify the administrative tasks associated with clinical trials. You can use diCELLa CTMS to prepare contracts, agreements, and study procedures, streamlining the documentation process.
• Budget Management: Gain control over your study's finances with our budget management capabilities. diCELLa CTMS allows you to monitor expenses, allocate resources, and ensure that your trial stays within budgetary constraints.

With diCELLa CTMS, you'll not only streamline the management of your clinical trial but also gain valuable insights and control over key aspects of the study. Our software is designed to simplify the complex tasks involved in clinical research, ultimately enabling you to run your trial efficiently and effectively.

Managing the documentation and records for a clinical trial is a critical aspect of ensuring regulatory compliance and efficient trial operations. At diCELLa, we offer robust solutions for both the Electronic Trial Master File (eTMF) and the Electronic Investigator Site File (eISF).

These features are designed to streamline document management, enhance data security, and facilitate regulatory compliance throughout your clinical tri

• eTMF Management: Our eTMF functionality provides a digital repository for all essential trial documents and records. This includes the ability to store and organize documents related to the study protocol, regulatory submissions, investigator agreements, and more.
• eISF Management: The eISF module is designed to simplify the management of Investigator Site Files. It allows for the secure storage and organization of site-specific documents, such as informed consent forms, ethics committee approvals, and site correspondence.
• Document Version Control: Both eTMF and eISF modules feature robust version control, ensuring that the most up-to-date documents are easily accessible and that previous versions are securely archived. This promotes compliance with regulatory requirements.
• Electronic Signatures: Our software supports electronic signatures, making it possible to sign and approve documents digitally. This feature enhances the efficiency of document review and approval processes, reducing the need for physical signatures.
• Access Control: We offer role-based access control, allowing you to define and manage user permissions for accessing and modifying documents. This ensures that sensitive trial data and documents are protected and only accessible to authorized personnel.
• Audit Trails: Comprehensive audit trails provide a detailed record of all document activities, including views, edits, and approvals. This feature helps demonstrate compliance with regulatory standards and enables traceability for every document.
• Regulatory Compliance: Our eTMF and eISF modules are designed to align with regulatory guidelines, including 21 CFR Part 11 and ICH GCP E6(R2). This ensures that your electronic documentation meets the highest standards of compliance.

IWRS systems are a vital component of the clinical research process, playing a central role in the efficient management of various aspects of clinical trials.

By incorporating our IWRS module into your clinical trial, you can streamline trial operations, reduce manual errors, and improve overall efficiency. The system simplifies complex processes, enhances data accuracy, and ensures compliance with regulatory requirements.

Key Support Services:

• Patient Enrollment: Our IWRS system simplifies the patient enrollment process. It allows you to efficiently register and track participant details, ensuring accurate and timely enrollment into your trial.
• Randomization: Randomization is a critical element in clinical trials to minimize bias. Our IWRS module automates the randomization process, providing a secure and auditable method for assigning participants to treatment groups.
• Drug Supply Management: Efficiently manage the drug supply chain with our IWRS system. You can track drug inventory, monitor usage, and ensure a consistent and secure drug supply for your trial sites.
• Dosing and Dispensing: Our system facilitates dosing and dispensing of investigational products according to the trial protocol, helping maintain dosing accuracy and compliance.
• Real-Time Reporting: Gain real-time visibility into your trial's progress with comprehensive reporting tools. Generate reports on enrollment, randomization, drug inventory, and other critical trial metrics to make data-driven decisions.
• User-Friendly Interface: The intuitive design of our IWRS system ensures that users can easily navigate and perform essential tasks, minimizing the learning curve for trial personnel.
• Audit Trail: Comprehensive audit trails provide a detailed record of all system activities, including randomization assignments and drug supply movements. This feature enhances transparency and supports regulatory compliance.

Flexibility is a cornerstone of diCELLa's clinical trial software. We understand that clinical trials are dynamic endeavors, and your software should adapt to evolving needs.

Our platform empowers you with the following flexible capabilities to ensure your trial runs smoothly:

• Data Export: diCELLa's software allows you to export selected data with ease. Whether you need to share specific datasets with collaborators, regulatory authorities, or sponsors, our export functionality provides you with the flexibility to extract the data you require in your preferred format.
• Protocol Amendments: Clinical trials often necessitate protocol amendments to accommodate changes in study design or regulatory requirements. Our software supports seamless protocol modifications, ensuring that your trial remains compliant and aligned with your evolving research objectives.
• Customization: We understand that each clinical trial is unique. diCELLa's software can be tailored to match your specific requirements. Whether it's adding new data fields, adjusting workflows, or incorporating unique study parameters, our customization options ensure that the software aligns perfectly with your trial's needs.
• Role-Based Access: Our software provides role-based access control, allowing you to define user roles and permissions. This flexibility ensures that team members have the appropriate level of access to the system, enhancing data security and workflow efficiency.
• Real-time Updates: Stay informed about any changes or updates to your trial with our real-time notification system. Receive alerts about data modifications, protocol changes, or any other relevant updates, ensuring you're always in the loop.

At diCELLa, we believe that adaptability is key to the success of your clinical trial. Our flexible features are designed to empower you to make informed decisions, respond to changes quickly, and maintain compliance throughout your trial's lifecycle.

At diCELLa, we recognize that the success of your clinical trial relies not only on our software but also on the support and collaboration of your entire team.

We are committed to providing comprehensive team support throughout your trial journey, ensuring that you have the guidance, resources, and assistance you need to achieve your research goals.

Key Support Services:

• Dedicated Account Manager: Upon adopting diCELLa's clinical trial software, you will be assigned a dedicated account manager who will serve as your primary point of contact. Your account manager will be there to address your inquiries, provide guidance, and coordinate any necessary assistance.
• Training and Onboarding: We offer robust training programs to ensure that your team is proficient in using our software. Whether you're onboarding new team members or seeking advanced training for existing staff, our training sessions are tailored to meet your specific needs.
• Technical Support: Our technical support team is available to assist you with any software-related issues or technical challenges that may arise during your trial. You can reach out to our support team via phone, email, or our dedicated support portal for prompt assistance.
• Customized Support Plans: We understand that every trial and team is unique. We offer customized support plans tailored to your specific requirements. Whether you need additional on-site training, specialized technical assistance, or extended support hours, we can accommodate your needs.

At diCELLa, we consider ourselves an extension of your team. We are dedicated to your success and are committed to providing the support necessary to ensure your clinical trial runs smoothly and efficiently. Your team's satisfaction and confidence in using our software are paramount to us.

At diCELLa, we take pride in staying at the forefront of technology to deliver cutting-edge solutions that enhance your clinical trial experience.

Our technology stack is designed to empower you with the tools and insights necessary to conduct your clinical trial with confidence and efficiency in a rapidly evolving research landscape.

• Python and Django Framework: Our software is developed using Python, a versatile and widely adopted programming language known for its readability and flexibility. Python's extensive ecosystem and libraries enable us to create a robust and efficient platform. We utilize the Django web framework, built on Python, renowned for its security, scalability, and ease of development. This combination ensures a stable and feature-rich platform that can be easily tailored to your needs.
• Advanced Data Analysis: In the realm of clinical trials, data analysis is paramount. We integrate the latest data analysis tools and techniques into our software, allowing you to derive meaningful insights from your trial data. Our data analysis capabilities are designed to facilitate real-time monitoring, identify trends, and support evidence-based decision-making throughout your trial.
• Data Security and Compliance: We prioritize data security and compliance with industry standards. Our software incorporates the latest security protocols and encryption methods to protect your sensitive trial data. Additionally, we maintain compliance with regulatory requirements, including the stringent provisions of 21 CFR Part 11.
• Scalability and Performance: Our software is architected with scalability in mind. Whether your trial involves a small cohort or a large-scale study, diCELLa's platform can effortlessly scale to accommodate your data requirements. This scalability ensures consistent performance, even as your trial grows, allowing you to maintain efficiency and accuracy.
• Continuous Innovation: Innovation is a core part of diCELLa's DNA. We are committed to staying at the forefront of technology and continuously enhancing our software. Our development team actively seeks out emerging technologies and best practices to integrate into our platform, ensuring that you have access to the most advanced tools and features available.

At diCELLa, your satisfaction is our top priority. We understand that choosing the right clinical trial software is a critical decision for your research endeavors.

We are dedicated to ensuring that your experience with our software exceeds your expectations at every step of your trial journey.

• Tailored Solutions for Your Success: Our commitment to satisfaction begins with our tailored approach to meet your unique needs. We work closely with you to understand the specific requirements of your clinical trial and customize our software accordingly. This ensures that our solution aligns perfectly with your research objectives, providing you with the tools and features you need for success.
• Dedicated Customer Support: We take pride in our dedicated customer support team, which is available to assist you whenever you need it. Whether you have questions, encounter technical issues, or require guidance, our responsive and knowledgeable support staff is just a call or message away. We are committed to providing timely and effective solutions to address your concerns.
• Continuous Training and Education: We believe that ongoing training and education are essential for maximizing the value of our software. Our comprehensive training programs empower your team with the knowledge and skills required to make the most of our platform. We offer resources, webinars, and documentation to ensure that you are well-equipped to use our software effectively.
• Proactive Updates and Enhancements: To enhance your experience and meet evolving industry standards, we regularly release updates and enhancements to our software. These updates may include new features, improved performance, security enhancements, and compliance updates. We proactively seek feedback from our users to drive these improvements, ensuring that our software remains at the cutting edge of technology.
• Feedback-Driven Improvement: Your feedback matters to us. We actively encourage and value your input, as it drives our continuous improvement efforts. We have established mechanisms for gathering and acting upon your suggestions, ensuring that our software evolves in a way that best serves your needs.