Clinical data management is the most important topic in the domain of clinical research, it refers to the process of collecting, cleaning, organising, validating, and managing data obtained during clinical trials or patient care in a systematic and structured manner.
Its primary goal is to ensure the accuracy, integrity, and reliability of the data collected, allowing all the stakeholders to make well-informed decisions based on high-quality information.
As a company completely dedicated to the Life Science domain, we are an exceptional Clinical Research Technology Solutions and Services provider.
Are you conducting different types of studies from Phase I to Phase II, III or IV and have an increasing need for different and complex technology solutions around the clinical trial process to optimise and oversight projects, make the right decisions and be supported by a consolidated decisional process based on data?
The selection of these solutions is far beyond choosing a single study tool; it should be closely associated with your Clinical Development Roadmap and Digital Strategy.
We are your trusted partner who will accelerate your overall clinical development.
Having the clinical business and technology knowledge, we will help you to identify and mitigate risks, and keep your clinical programs on track and accelerate clinical programs.
We will provide you with value-added services to secure your operational success and compliance.
Governance and Oversight Solutions
According to the Good Clinical Practice of EMA, ICH GCP E6 (R2), Pharmaceutical and Biotech companies are required to implement a more structured and comprehensive monitoring of their projects.
This requires a set of processes and tools, put in place by the sponsor and the CRO, with the aim of providing the sponsor with a constantly updated overview of the CRO’s performance in projects, timelines, quality and results. The objective is to ensure the sponsor a proper oversight over the studies.
At Arithmos, we developed a comprehensive approach for Clinical Trial Oversight Management, from requirements analysis to the technology selection, implementation, integration and customization of the solutions.
In collaboration with our strategic Partners, we also provide complete support in the reorganisation of Quality Systems, using a risk-based approach.
SOPs Evaluation and Generation
The development and maintenance of a robust Quality Management System is fundamental to ensuring compliance with good practice quality guidelines and regulations.
We provide Life Sciences companies with full support in setting up, managing, delivering and validating QMS, through processes and SOPs evaluation and generation.
Our personable, knowledgeable team provides GAP analyses, process mapping, and the development of a tailored set of policies and procedures that are simple, practical and phase-appropriate, facilitating effective operation in all areas.
Our team will ensure your Quality Management System is inspection ready, meeting the requirements of the applicable Regulatory Authorities and fulfilling your obligations for sponsor oversight.
We also provide digital solutions for QMS and Digital Validation, selected, integrated and configured for your needs.
Vendor selection is a critical opportunity to gauge the impact or risks suppliers can have to help Life Sciences companies bring products to the market that improve patients’ lives.
Our proven and formal selection process enables you to build strategy-driven and future-focused partnerships that ensure compliance.
Depending on the exact purpose of your company, we select and integrate the best technology solution for your individual needs, in accordance with the regulatory requirements and good practice.
Our team at Arithmos has a long experience and a strong network of Partners, helping companies select the most sustainable and scalable technology solutions to meet their current business needs and long-term objectives.
eCRF, ePRO, DCT, eTMF | Accelerate the clinical trial process
How are you managing your clinical trials?
Conduct your clinical studies in less time, and collect high-quality, direct-from-patient data with advanced patient assessments in a streamlined, compliant, and efficient manner.
Arithmos applies standardised and established data management processes to ensure integral, analysable data and real-time availability in a secure and protected environment.
We have solutions focused on:
Electronic Case Report Form (eCRF)
Electronic Patient-Reported Outcomes (ePRO)
Electronic Trial Master File (eTMF)
customizable by customer and study.
User Acceptance Testing is a crucial phase in the software development process, where the system or application is tested by end-users or client representatives to ensure that it meets their requirements and expectations before it is deployed into production.
We apply best practices to support the successful roll out of new software.
With our network of Partners and our extensive expertise, we support you to adopt the right solutions and maximise the value all relevant stakeholders can benefit.
Clinical trials play a crucial role in advancing medical research and finding new treatments for various diseases; however, the traditional methods of conducting clinical trials are often time-consuming, expensive, and can have limitations in capturing real-time patient data.
The emergence of digital endpoints in clinical trials has the potential to revolutionise the way research is conducted, enabling more efficient and accurate real-time data collection, enhancing patient engagement, improving efficiency, reducing costs, and accelerating the development of life-saving therapies.
Endpoint strategy consultation
Drawing on our technical, scientific and digital transformation expertise, we work with organisations to develop programmes with endpoints that meet their strategic objectives.